ESBRIET Drug Patent Profile
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Which patents cover Esbriet, and when can generic versions of Esbriet launch?
Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. There are twenty patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and sixty-three patent family members in forty-five countries.
The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Esbriet
A generic version of ESBRIET was approved as pirfenidone by AMNEAL on January 3rd, 2022.
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Summary for ESBRIET
| International Patents: | 263 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 142 |
| Clinical Trials: | 19 |
| Patent Applications: | 5,268 |
| Drug Prices: | Drug price information for ESBRIET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESBRIET |
| What excipients (inactive ingredients) are in ESBRIET? | ESBRIET excipients list |
| DailyMed Link: | ESBRIET at DailyMed |
Recent Clinical Trials for ESBRIET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Excalibur Pharmaceuticals, Inc. | Phase 1 |
| San Diego Veterans Healthcare System | Phase 2 |
| Veterans Medical Research Foundation | Phase 2 |
Pharmacology for ESBRIET
| Drug Class | Pyridone |
Paragraph IV (Patent) Challenges for ESBRIET
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ESBRIET | Capsules | pirfenidone | 267 mg | 022535 | 9 | 2018-10-15 |
| ESBRIET | Tablets | pirfenidone | 534 mg | 208780 | 2 | 2018-10-15 |
US Patents and Regulatory Information for ESBRIET
ESBRIET is protected by sixty-four US patents.
Patents protecting ESBRIET
Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same
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Modifying pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Modifying pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
Modifying pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
Modifying pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE THEN FULL DAILY DOSE IN TREATMENT OF IPF
Modifying pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
Method of providing pirfenidone therapy to a patient
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Patented Use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patented Use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
Method of providing pirfenidone therapy to a patient
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Patented Use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Method of providing pirfenidone therapy to a patient
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Patented Use: PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
Methods of administering pirfenidone therapy
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Methods of administering pirfenidone therapy
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Patented Use: DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
Methods of administering pirfenidone therapy
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Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
Methods of administering pirfenidone therapy
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2
Methods of administering pirfenidone therapy
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Patented Use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
Methods of administering pirfenidone therapy
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Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patented Use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
Methods of administering pirfenidone therapy
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Methods of administering pirfenidone therapy
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Patented Use: ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Methods of administering pirfenidone therapy
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Patented Use: MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: DISCONTINUING A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Methods of administering pirfenidone therapy
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
Methods of administering pirfenidone therapy
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Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
Methods of administering pirfenidone therapy
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Patented Use: DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
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Patented Use: METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
Method of providing pirfenidone therapy to a patient
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Patented Use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
Method of providing pirfenidone therapy to a patient
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Patented Use: PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
Pirfenidone treatment for patients with atypical liver function
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Patented Use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
Pirfenidone treatment for patients with atypical liver function
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Patented Use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN USE OF PIRFENIDONE
Pirfenidone treatment for patients with atypical liver function
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Patented Use: FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
Pirfenidone treatment for patients with atypical liver function
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Patented Use: DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patented Use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
Pirfenidone therapy and inducers of cytochrome P450
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Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
Methods of administering pirfenidone therapy
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Patented Use: DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH CIPROFLOXACIN
Methods of administering pirfenidone therapy
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Patented Use: DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
Methods of administering pirfenidone therapy
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Patented Use: ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ESBRIET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-002 | Jan 11, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ESBRIET
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Roche Registration GmbH | Esbriet | pirfenidone | EMEA/H/C/002154 Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis. |
Authorised | no | no | no | 2011-02-27 | |
| Axunio Pharma GmbH | Pirfenidone axunio (previously Pirfenidone AET) | pirfenidone | EMEA/H/C/005873 Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). |
Authorised | yes | no | no | 2022-06-20 | |
| Viatris Limited | Pirfenidone Viatris | pirfenidone | EMEA/H/C/005862 Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). |
Authorised | yes | no | no | 2023-01-10 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ESBRIET
When does loss-of-exclusivity occur for ESBRIET?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 55
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Argentina
Patent: 7990
Patent: FORMULACIÓN GRANULADA DE 5-METIL-1-FENIL-2-(1H)-PIRIDONA Y MÉTODO PARA ELABORARLA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 06295440
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patent: 11201520
Patent: Capsule Formulation Of Pirfenidone And Pharmaceutically Acceptable Excipients
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Patent: 13201986
Patent: Capsule Formulation Of Pirfenidone And Pharmaceutically Acceptable Excipients
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Patent: 14240300
Patent: Capsule Formulation of Pirfenidone and Pharmaceutically Acceptable Excipients
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Patent: 17241530
Patent: Granulate formulation of 5-methy|-1-pheny|-2(1H)-pyridone and method of making the same
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Patent: 22275529
Patent: Granulate formulation of 5-methyl-1-phenyl-2(1H)-pyridone and method of making the same
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Brazil
Patent: 0616324
Patent: formulaÇço de cÁpsula de pirfenidona e excipientes farmaceuticamente aceitÁveis
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Canada
Patent: 20380
Patent: FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
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Patent: 62013
Patent: FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
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Patent: 37365
Patent: FORMULATION EN GRANULES DE 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE ET METHODE DE FABRICATION ASSOCIEE (GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
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China
Patent: 1267810
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patent: 3393607
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patent: 3735530
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patent: 8883072
Patent: 5-甲基-1-苯基-2-(1H)-吡啶酮颗粒制剂和其制备方法 (GRANULATE FORMULATION OF 5-METHY-1-PHENY-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 4533688
Patent: 5-甲基-1-苯基-2-(1H)-吡啶酮颗粒制剂和其制备方法 (5-methyl-1-phenyl-2-(1H)-pyridone granular formulations and processes for their preparation)
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Cuba
Patent: 080043
Patent: FORMULACIÓN DE CÁPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACÉUTICAMENTE ACEPTABLES
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Cyprus
Patent: 15544
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 40364
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 088394
Patent: FORMULACIÓN DE CÁPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACÉUTICAMENTE ACEPTABLES
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Eurasian Patent Organization
Patent: 0093
Patent: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
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Patent: 0800881
Patent: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 40364
Patent: CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
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Patent: 31025
Patent: Formulation de capsule de pirfénidone et excipients pharmaceutiquement acceptables (Capsule formulation of pirfenidone and pharmaceutically acceptable excipients)
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Patent: 35985
Patent: PRÉPARATION DE GRANULÉS DE 5-MÉTHYL-1-PHÉNYL-2(1H)-PYRIDONE ET SON PROCÉDÉ DE FABRICATION (GRANULATE FORMULATION OF 5-METHY!-1-PHENY!-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 95696
Patent: PRÉPARATION DE GRANULÉS DE 5-MÉTHYL-1-PHÉNYL-2(1H)-PYRIDONE ET SON PROCÉDÉ DE FABRICATION (GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0115303
Patent: CAPSULE OF PIRFENIDONE
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 17762
Patent: 吡非尼酮與藥學上可接受的賦形劑的膠囊製劑 (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9273
Patent: תצורה קפסולרית של פירפנידון וחומרי תרופה בלתי-פעילים המתאימים מבחינה פרמצבטית (Capsule formulation of pirfenidone and pharmaceutically acceptable excipients)
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Patent: 1745
Patent: פורמולציית גרגירים של 5-מתיל-1-פניל-2(h1)-פירידון ושיטה להכנתה (Granulate formulation of 5-methyl-1-phenyl-2(1h)-pyridone and method of making the same)
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Japan
Patent: 15101
Estimated Expiration: ⤷ Sign Up
Patent: 37732
Estimated Expiration: ⤷ Sign Up
Patent: 56721
Estimated Expiration: ⤷ Sign Up
Patent: 09509962
Estimated Expiration: ⤷ Sign Up
Patent: 12224641
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENT
Estimated Expiration: ⤷ Sign Up
Patent: 14169341
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Sign Up
Patent: 19513145
Patent: ５−メチル−１−フェニル−２−（１Ｈ）−ピリドンの顆粒製剤及びその製造方法
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Patent: 22087115
Patent: ５－メチル－１－フェニル－２－（１Ｈ）－ピリドンの顆粒製剤及びその製造方法
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Mexico
Patent: 08003882
Patent: FORMULACION DE CAPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACEUTICAMENTE ACEPTABLES. (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS.)
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Patent: 18011819
Patent: FORMULACION GRANULADA DE 5-METIL-1-FENIL-2-(1H)-PIRIDONA Y METODO PARA ELABORARLA. (GRANULATE FORMULATION OF 5-METHY|-1-PHENY|-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME.)
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Morocco
Patent: 875
Patent: FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES
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New Zealand
Patent: 5957
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
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Patent: 1443
Patent: Granule formation of pirfenidone and pharmaceutically acceptable excipients
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Patent: 0129
Patent: Capsule formation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 5131
Estimated Expiration: ⤷ Sign Up
Patent: 080759
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 40364
Estimated Expiration: ⤷ Sign Up
Patent: 35985
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 40364
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 40364
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0802237
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1645069
Estimated Expiration: ⤷ Sign Up
Patent: 1675651
Estimated Expiration: ⤷ Sign Up
Patent: 2552615
Estimated Expiration: ⤷ Sign Up
Patent: 080046673
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Sign Up
Patent: 130100381
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Sign Up
Patent: 140029554
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Sign Up
Patent: 180123067
Patent: 5-메틸-1-페닐-2-(1H)-피리돈의 과립화 제형 및 이의 제조 방법
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 96144
Estimated Expiration: ⤷ Sign Up
Patent: 83595
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 08136
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 433
Patent: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ;ЛІКАРСЬКА ФОРМА ПІРФЕНІДОНУ У ВИГЛЯДІ КАПСУЛ З ФАРМАЦЕВТИЧНО ПРИЙНЯТНИМИ ЕКСЦИПІЄНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 5861
Patent: ЛІКАРСЬКА ФОРМА ПІРФЕНІДОНУ У ВИГЛЯДІ КАПСУЛ З ФАРМАЦЕВТИЧНО ПРИЙНЯТНИМИ ЕКСЦИПІЄНТАМИ
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ESBRIET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20170109079 | 피르페니돈 요법의 실시 방법 (METHODS OF ADMINISTERING PIRFENIDONE THERAPY) | ⤷ Sign Up |
| Ukraine | 99433 | ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ;ЛІКАРСЬКА ФОРМА ПІРФЕНІДОНУ У ВИГЛЯДІ КАПСУЛ З ФАРМАЦЕВТИЧНО ПРИЙНЯТНИМИ ЕКСЦИПІЄНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS) | ⤷ Sign Up |
| Australia | 2013204032 | Method of Administering Pirfenidone Therapy | ⤷ Sign Up |
| Portugal | 969873 | ⤷ Sign Up | |
| Norway | 345131 | ⤷ Sign Up | |
| New Zealand | 591443 | Granule formation of pirfenidone and pharmaceutically acceptable excipients | ⤷ Sign Up |
| Cyprus | 1115544 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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