Sildenafil citrate - Generic Drug Details
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What are the generic drug sources for sildenafil citrate and what is the scope of freedom to operate?
Sildenafil citrate
is the generic ingredient in four branded drugs marketed by Viatris, 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, Cmp Dev Llc, 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 fifty-two NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sildenafil citrate has nine patent family members in nine countries.
There are eighteen drug master file entries for sildenafil citrate. Sixty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for sildenafil citrate
International Patents: | 9 |
US Patents: | 4 |
Tradenames: | 4 |
Applicants: | 36 |
NDAs: | 52 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 68 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 138 |
Patent Applications: | 7,181 |
Drug Prices: | Drug price trends 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 |
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 |
Generic filers with tentative approvals for SILDENAFIL CITRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 100MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 50MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 25MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 077342-003 | Mar 9, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | SILDENAFIL CITRATE | sildenafil citrate | FOR SUSPENSION;ORAL | 211534-001 | May 29, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Lifesciences | SILDENAFIL CITRATE | sildenafil citrate | FOR SUSPENSION;ORAL | 215708-001 | Sep 29, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms Ny | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 202023-003 | Jun 27, 2018 | 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 |
Expired US Patents for sildenafil citrate
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 | REVATIO | sildenafil citrate | SOLUTION;INTRAVENOUS | 022473-001 | Nov 18, 2009 | ⤷ 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sildenafil citrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2019130052 | ⤷ Sign Up | |
Singapore | 11202006080S | LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS | ⤷ Sign Up |
Brazil | 112020012986 | formulações orais líquidas para inibidores de pde v | ⤷ Sign Up |
Japan | 2021509114 | PDE V阻害剤のための液体経口処方物 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sildenafil citrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 | 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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