REVATIO Drug Patent Profile
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Which patents cover Revatio, and what generic alternatives are available?
Revatio is a drug marketed by Viatris and is included in three NDAs.
The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Revatio
A generic version of REVATIO was approved as sildenafil citrate by CHARTWELL RX on November 6th, 2012.
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Summary for REVATIO
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 65 |
| Patent Applications: | 5,557 |
| Drug Prices: | Drug price information for REVATIO |
| What excipients (inactive ingredients) are in REVATIO? | REVATIO excipients list |
| DailyMed Link: | REVATIO at DailyMed |
Recent Clinical Trials for REVATIO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Texas Medical Branch, Galveston | Phase 2 |
| Christoph P Hornik, MD MPH | Phase 2 |
| Actelion | Phase 1 |
Pharmacology for REVATIO
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
US Patents and Regulatory Information for REVATIO
REVATIO is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting REVATIO
LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP I) IN PEDIATRIC PATIENTS 1 TO 17 YEARS OLD TO IMPROVE EXERCISE ABILITY AND, IN PEDIATRIC PATIENTS TOO YOUNG TO PERFORM STANDARDIZED EXERCISE TESTING, PULMONARY HEMODYNAMICS THOUGHT TO UNDERLY IMPROVEMENTS IN EXERCISE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viatris | REVATIO | sildenafil citrate | FOR SUSPENSION;ORAL | 203109-001 | Aug 30, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | REVATIO | sildenafil citrate | TABLET;ORAL | 021845-001 | Jun 3, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | REVATIO | sildenafil citrate | SOLUTION;INTRAVENOUS | 022473-001 | Nov 18, 2009 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | REVATIO | sildenafil citrate | TABLET;ORAL | 021845-001 | Jun 3, 2005 | AB | 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 |
Expired US Patents for REVATIO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | REVATIO | sildenafil citrate | SOLUTION;INTRAVENOUS | 022473-001 | Nov 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | REVATIO | sildenafil citrate | TABLET;ORAL | 021845-001 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REVATIO
See the table below for patents covering REVATIO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 279289 | Pyrazolopyrimidinonové sloučeniny, způsob jejich přípravy, farmaceutický prostředek a použití těchto sloučenin (PYRAZOLOPYRIMIDINONES PROCESS OF THEIR PREPARATION, PHARMACEUTICAL COMPOSITION CONTAINING THEREOF AND THE USE OF SUCH COMPOUNDS) | ⤷ Sign Up |
| Poland | 166490 | ⤷ Sign Up | |
| Netherlands | 990005 | ⤷ Sign Up | |
| Poland | 290721 | ⤷ Sign Up | |
| Hungary | T61312 | ⤷ Sign Up | |
| Hungary | 912061 | ⤷ Sign Up | |
| Hungary | 218945 | Pirazolo-pirimidinon-származékok és a vegyületeket tartalmazó gyógyászati készítmények, eljárás a vegyületek és a készítmények előállítására (PYRAZOLO PYRIMIDINONE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, PROCESS FOR PRODUCING THE COMPOUNDS AND THE COMPOSITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REVATIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0463756 | C990005 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622 |
| 0463756 | SPC/GB99/004 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914 |
| 0463756 | 99C0007 | Belgium | ⤷ Sign Up | PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622 |
| 0463756 | 300048 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307 |
| 0463756 | 5/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622 |
| >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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