REVATIO Drug Patent Profile
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When do Revatio patents expire, and when can generic versions of Revatio launch?
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-five 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.
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: | 5,838 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for REVATIO
US Patents and Regulatory Information for REVATIO
REVATIO is protected by zero US patents and one FDA Regulatory Exclusivity.
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Viatris | REVATIO | sildenafil citrate | SOLUTION;INTRAVENOUS | 022473-001 | Nov 18, 2009 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Viatris | REVATIO | sildenafil citrate | TABLET;ORAL | 021845-001 | Jun 3, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Viatris | REVATIO | sildenafil citrate | TABLET;ORAL | 021845-001 | Jun 3, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Hungary | 912061 | ⤷ Try a Trial | |
Russian Federation | 2047617 | METHOD OF SYNTHESIS OF PYRAZOLOPYRIMIDINE COMPOUNDS OR THEIR PHARMACEUTICALLY ACCEPTABLE SALTS | ⤷ Try a Trial |
Norway | 178029 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REVATIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0463756 | 300048 | Netherlands | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 |
0463756 | SPC/GB99/004 | United Kingdom | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |