SILDENAFIL CITRATE Drug Patent Profile
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When do Sildenafil Citrate patents expire, and what generic alternatives are available?
Sildenafil Citrate is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Appco, Aptapharma Inc, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Lupin Ltd, MSN, Novitium Pharma, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Cadila Pharms Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc. and is included in forty-seven NDAs.
The generic ingredient in SILDENAFIL CITRATE 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 Sildenafil Citrate
A generic version of SILDENAFIL CITRATE was approved as sildenafil citrate by CHARTWELL RX on November 6th, 2012.
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Questions you can ask:
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Summary for SILDENAFIL CITRATE
| US Patents: | 0 |
| Applicants: | 34 |
| NDAs: | 47 |
| Finished Product Suppliers / Packagers: | 65 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 138 |
| Patent Applications: | 5,557 |
| Drug Prices: | Drug price information for SILDENAFIL CITRATE |
| Drug Sales Revenues: | Drug sales revenues for SILDENAFIL CITRATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SILDENAFIL CITRATE |
| What excipients (inactive ingredients) are in SILDENAFIL CITRATE? | SILDENAFIL CITRATE excipients list |
| DailyMed Link: | SILDENAFIL CITRATE at DailyMed |
See drug prices for SILDENAFIL CITRATE
Recent Clinical Trials for SILDENAFIL CITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Batterjee Medical College | Phase 4 |
| University of Pennsylvania | Phase 2 |
| Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso | Phase 4 |
Pharmacology for SILDENAFIL CITRATE
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for SILDENAFIL CITRATE
Anatomical Therapeutic Chemical (ATC) Classes for SILDENAFIL CITRATE
Paragraph IV (Patent) Challenges for SILDENAFIL CITRATE
| 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 SILDENAFIL CITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 091448-001 | Jun 11, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd V | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 203623-001 | Nov 26, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 203962-002 | Jun 11, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 201171-001 | Mar 25, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Reyoung | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 208494-003 | Jun 12, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 203814-001 | Dec 17, 2013 | AB | RX | No | No | ⤷ 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 |
