VIAGRA Drug Patent Profile
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Which patents cover Viagra, and when can generic versions of Viagra launch?
Viagra is a drug marketed by Viatris and is included in one NDA.
The generic ingredient in VIAGRA 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 Viagra
A generic version of VIAGRA was approved as sildenafil citrate by CHARTWELL RX on November 6th, 2012.
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Summary for VIAGRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 160 |
| Patent Applications: | 5,557 |
| Drug Prices: | Drug price information for VIAGRA |
| Drug Sales Revenues: | Drug sales revenues for VIAGRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIAGRA |
| What excipients (inactive ingredients) are in VIAGRA? | VIAGRA excipients list |
| DailyMed Link: | VIAGRA at DailyMed |
Recent Clinical Trials for VIAGRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Rouen | Phase 3 |
| Pia Wintermark | Phase 2 |
| Al-Azhar University | Phase 2 |
Pharmacology for VIAGRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Paragraph IV (Patent) Challenges for VIAGRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VIAGRA | Tablets | sildenafil citrate | 25 mg and 50 mg | 020895 | 1 | 2004-11-19 |
| VIAGRA | Tablets | sildenafil citrate | 100 mg | 020895 | 1 | 2004-10-25 |
US Patents and Regulatory Information for VIAGRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | 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 VIAGRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIAGRA
See the table below for patents covering VIAGRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1971 | Pyrazolopyrimidinone antianginal agents | ⤷ Sign Up |
| Finland | 955911 | ⤷ Sign Up | |
| Norway | 912366 | ⤷ Sign Up | |
| Japan | H11263728 | THERAPEUTIC AGENT FOR GENITAL INSUFFICIENCY | ⤷ Sign Up |
| Norway | 1999004 | ⤷ Sign Up | |
| Yugoslavia | 47962 | ⤷ Sign Up | |
| Czechoslovakia | 9101876 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIAGRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 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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