TARPEYO Drug Patent Profile
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Which patents cover Tarpeyo, and what generic alternatives are available?
Tarpeyo is a drug marketed by Calliditas and is included in one NDA. There are two patents protecting this drug.
This drug has fifteen patent family members in ten countries.
The generic ingredient in TARPEYO is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tarpeyo
A generic version of TARPEYO was approved as budesonide by TEVA PHARMS on November 18th, 2008.
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Summary for TARPEYO
| International Patents: | 15 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for TARPEYO |
| What excipients (inactive ingredients) are in TARPEYO? | TARPEYO excipients list |
| DailyMed Link: | TARPEYO at DailyMed |
Pharmacology for TARPEYO
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for TARPEYO
TARPEYO is protected by three US patents and three FDA Regulatory Exclusivities.
Patents protecting TARPEYO
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION IN LOSS OF KIDNEY FUNCTION AND REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
Compositions for the oral delivery of corticosteroids
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION
Compositions for the oral delivery of corticosteroids
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION IN LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION
FDA Regulatory Exclusivity protecting TARPEYO
TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G
Exclusivity Expiration: ⤷ Sign Up
TO REDUCE THE LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON DECEMBER 15, 2021
Exclusivity Expiration: ⤷ Sign Up
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calliditas | TARPEYO | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 215935-001 | Dec 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Calliditas | TARPEYO | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 215935-001 | Dec 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Calliditas | TARPEYO | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 215935-001 | Dec 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Calliditas | TARPEYO | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 215935-001 | Dec 15, 2021 | RX | Yes | Yes | ⤷ 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 |
EU/EMA Drug Approvals for TARPEYO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Dr. Falk Pharma GmbH | Jorveza | budesonide | EMEA/H/C/004655 Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). |
Authorised | no | no | yes | 2018-01-08 | |
| Stada Arzneimittel AG | Kinpeygo | budesonide | EMEA/H/C/005653 Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. |
Authorised | no | no | yes | 2022-07-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TARPEYO
See the table below for patents covering TARPEYO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2011519967 | ⤷ Sign Up | |
| Poland | 2278958 | ⤷ Sign Up | |
| European Patent Office | 2278958 | COMPOSITIONS POUR L'ADMINISTRATION DE CORTICOSTÉROÏDES PAR VOIE ORALE (COMPOSITIONS FOR THE ORAL DELIVERY OF CORTICOSTEROIDS) | ⤷ Sign Up |
| Spain | 2452265 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TARPEYO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | SPC/GB21/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
| 2435024 | LUC00208 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| 2435024 | 21C1020 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
| 2435024 | 2190014-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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