FAMOTIDINE - Generic Drug Details
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What are the generic drug sources for famotidine and what is the scope of freedom to operate?
Famotidine
is the generic ingredient in fourteen branded drugs marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Unichem, Upsher Smith Labs, Salix Pharms, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Epic Pharma Llc, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, MSN, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Bausch, Horizon, Torrent, Endo Operations, and Teva Pharms Usa, and is included in ninety-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for famotidine. One hundred and forty-four suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for FAMOTIDINE
US Patents: | 5 |
Tradenames: | 14 |
Applicants: | 62 |
NDAs: | 97 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 144 |
Raw Ingredient (Bulk) Api Vendors: | 83 |
Clinical Trials: | 118 |
Patent Applications: | 7,261 |
Drug Prices: | Drug price trends for FAMOTIDINE |
Drug Sales Revenues: | Drug sales revenues for FAMOTIDINE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FAMOTIDINE |
What excipients (inactive ingredients) are in FAMOTIDINE? | FAMOTIDINE excipients list |
DailyMed Link: | FAMOTIDINE at DailyMed |
Recent Clinical Trials for FAMOTIDINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Miami | Phase 3 |
Celgene | Phase 1 |
CURE Drug Repurposing Collaboratory (CDRC) | Phase 3 |
Generic filers with tentative approvals for FAMOTIDINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MG/ML | Injectable; Injection |
⤷ Sign Up | ⤷ Sign Up | 10MG/ML | Injectable; Injection |
⤷ Sign Up | ⤷ Sign Up | 10MG/ML | Injectable; Injection |
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 FAMOTIDINE
Drug Class | Histamine-2 Receptor Antagonist |
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for FAMOTIDINE
Anatomical Therapeutic Chemical (ATC) Classes for FAMOTIDINE
US Patents and Regulatory Information for FAMOTIDINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkem Labs Ltd | FAMOTIDINE | famotidine | TABLET;ORAL | 217375-001 | Apr 24, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Msn | FAMOTIDINE | famotidine | TABLET;ORAL | 217400-001 | Aug 6, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apothecon | FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075708-001 | Apr 16, 2001 | DISCN | 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 FAMOTIDINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | PEPCID AC | famotidine | TABLET, CHEWABLE;ORAL | 020801-002 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020902-001 | Aug 5, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | PEPCID | famotidine | TABLET;ORAL | 019462-001 | Oct 15, 1986 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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