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VIAGRA Drug Profile
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» See Plans and PricingWhich 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 November 6th, 2012.
Summary for VIAGRA
| International Patents: | 45 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 81 |
| Clinical Trials: | 135 |
| Patent Applications: | 5,588 |
| 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 |
|---|---|
| Ain Shams University | N/A |
| University of British Columbia | 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 |
Synonyms for VIAGRA
| 1-((3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methylpiperazine |
| 1-((3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methylpiperazine citrate |
| 139755-83-2 |
| 1udt |
| 1xos |
| 2h42 |
| 3M7OB98Y7H |
| 4-((4-Ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydr |
| 5-(2-ethoxy-5-((4-methylpiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-(2-Ethoxy-5-((4-methylpiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one |
| 5-[2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonyl-phenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1-methyl-3-n-propyl-1.6-dihydro-7H-pyrazolo[4,3-d]Pyrimidin-7-one |
| 5-[2-ethoxy-5-(4-methylpiperazine-1-sulfonyl)phenyl]-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-[2-ethoxy-5-(4-methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo(4,3-d]pyrimidin-7-one |
| 5-[2-ethoxy-5-(4-methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-{2-(ethyloxy)-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1,4-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7-ol |
| 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 5-{2-ETHOXY-5-[(4-METHYLPIPERAZIN-1-YL)SULFONYL]PHENYL}-1-METHYL-3-PROPYL-1H,6H,7H-PYRAZOLO[4,3-D]PYRIMIDIN-7-ONE |
| 5-{2-ethoxy-5-[(4-methylpiperazine-1-)sulfonyl]phenyl}-1-methyl-3-propyl-1H,6H,7H-pyrazolo[4,3-d]pyrimidin-7-one |
| 755S832 |
| AB00052444_04 |
| AB00052444_05 |
| AB00052444-02 |
| AB00052444-03 |
| AB0015440 |
| AC-938 |
| ACT02662 |
| AKOS008901403 |
| AKOS025397193 |
| Aphrodil (TN) |
| AS-48884 |
| BCP05337 |
| BDBM14390 |
| BIDD:GT0352 |
| BNRNXUUZRGQAQC-UHFFFAOYSA-N |
| BRD-K50128260-001-01-6 |
| BRD-K79759585-001-02-1 |
| BRD-K79759585-048-01-4 |
| BSPBio_003424 |
| C07259 |
| C22H30N6O4S |
| Cambridge id 7030299 |
| CCG-21806 |
| CCG-39076 |
| CHEBI:9139 |
| CHEMBL192 |
| CS-1577 |
| D08514 |
| DB00203 |
| DivK1c_006894 |
| DTXSID6023579 |
| FT-0601554 |
| GTPL4743 |
| HIP-0908 |
| HIP0908 |
| HMS1684K08 |
| HMS1922B19 |
| HMS2089M12 |
| HMS2093O17 |
| HMS2233L22 |
| HMS3372N07 |
| HMS3715P17 |
| HMS3740G19 |
| HSDB 7305 |
| HY-15025 |
| J-007309 |
| KBio1_001838 |
| KBio2_002035 |
| KBio2_004603 |
| KBio2_007171 |
| KBio3_002927 |
| KBioGR_001052 |
| KBioSS_002035 |
| KS-00000XMX |
| LS-111655 |
| M901 |
| MCULE-2481702478 |
| MLS001240224 |
| MLS001304737 |
| MLS006011565 |
| NCGC00095099-01 |
| NCGC00095099-02 |
| NCGC00095099-03 |
| NCGC00095099-04 |
| NCGC00159496-02 |
| NCGC00370976-03 |
| NCX-911 |
| Piperazine, 1-((3-(4,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methyl- |
| Q191521 |
| Revatio |
| s4684 |
| SB17345 |
| SBI-0051920.P002 |
| SC-83326 |
| SCHEMBL1895 |
| SCHEMBL5795456 |
| SCHEMBL8100377 |
| sildenafil |
| Sildenafil (INN) |
| Sildenafil [INN:BAN] |
| Sildenafil 1.0 mg/ml in Methanol |
| Sildenafil solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| SILDENAFIL; VIAGRA |
| Sildenafil# |
| SMR000752512 |
| SMR004703325 |
| SPBio_001775 |
| SpecPlus_000798 |
| Spectrum_001555 |
| SPECTRUM1504099 |
| Spectrum2_001648 |
| Spectrum3_001892 |
| Spectrum4_000586 |
| Spectrum5_001508 |
| SR-01000504734 |
| SR-01000504734-1 |
| SR-05000001934 |
| SR-05000001934-1 |
| SR-05000001934-2 |
| STL483201 |
| STL483720 |
| STL565123 |
| UK 92480-10 |
| UK-92,480-10 |
| UK-92480 |
| UNII-3M7OB98Y7H |
| Vizarsin |
| W-2194 |
| Z1522567175 |
| ZINC19796168 |
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 | 020895-003 | Mar 27, 1998 | Start Trial | Start Trial |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIAGRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Czechoslovakia | 9101876 | Start Trial |
| United Kingdom | 9311920 | Start Trial |
| Israel | 121836 | Start Trial |
| Japan | H11263728 | Start Trial |
| Czech Republic | 284946 | Start Trial |
| Norway | 321622 | Start Trial |
| Norway | 309227 | 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 | 300048 | Netherlands | Start 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 | 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 |
