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VIAGRA Drug Profile
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Which patents cover Viagra, and when can generic versions of Viagra launch?
Viagra is a drug marketed by Pfizer Inc and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has forty-five patent family members in twenty-six countries.
The generic ingredient in VIAGRA is sildenafil citrate. There are twenty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
US ANDA Litigation and Generic Entry Outlook for Viagra
A generic version of VIAGRA was approved as sildenafil citrate by HEBEI CHANGSHAN on January 24th, 2020.
Summary for VIAGRA
| International Patents: | 45 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 78 |
| Clinical Trials: | 135 |
| Patent Applications: | 6,329 |
| Formulation / Manufacturing: | see details |
| 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 |
| DailyMed Link: | VIAGRA at DailyMed |
Recent Clinical Trials for VIAGRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of British Columbia | N/A |
| Ain Shams University | N/A |
| Walter Reed National Military Medical Center | Phase 2 |
Recent Litigation for VIAGRA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Umedica Laboratories Pvt., Ltd. | 2017-10-31 |
| ERFINDERGEMEINSCHAFT UROPEP GbR v. Eli Lilly and Company | 2015-07-01 |
| Natural Alternatives International, Inc. v. Woodbolt Distribution, LLC | 2011-12-21 |
Pharmacology for VIAGRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Paragraph IV (Patent) Challenges for VIAGRA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIAGRA | TABLET;ORAL | sildenafil citrate | 020895 | 2004-11-19 |
| VIAGRA | TABLET;ORAL | sildenafil citrate | 020895 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Pfizer Inc | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Pfizer Inc | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 VIAGRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Inc | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | Start Trial | Start Trial |
| Pfizer Inc | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | Start Trial | Start Trial |
| Pfizer Inc | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIAGRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 227877 | Start Trial |
| Finland | 955911 | Start Trial |
| Cyprus | 2099 | Start Trial |
| Ecuador | SP941102 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIAGRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0463756 | C990005 | Netherlands | Start Trial | 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 | 99C0007 | Belgium | Start Trial | PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622 |
| 0463756 | 5/1999 | Austria | Start 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 | Start 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 |
