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 twelve branded drugs marketed by Akorn, Amneals Pharms, Lupin Ltd, Navinta Llc, Novel Labs Inc, Novitium Pharma, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Zydus Pharms, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Annora Pharma, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Ivax Sub Teva Pharms, Mankind Pharma, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Bausch, Horizon, and Teva Pharms Usa, and is included in eighty NDAs. There are six 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 thirteen suppliers are listed for this compound.
Summary for famotidine
US Patents: | 6 |
Tradenames: | 12 |
Applicants: | 50 |
NDAs: | 80 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 113 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 111 |
Patent Applications: | 7,290 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Mainline Biosciences, Inc. | Early Phase 1 |
Assistance Publique - Hôpitaux de Paris | Phase 2/Phase 3 |
INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, Paris | Phase 2/Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Ltd | FAMOTIDINE | famotidine | TABLET;ORAL | 075718-002 | Apr 16, 2001 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Abbvie | FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER | famotidine | INJECTABLE;INJECTION | 075729-001 | Dec 17, 2001 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Zydus Pharms | FAMOTIDINE | famotidine | TABLET;ORAL | 216441-001 | Jun 3, 2022 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | 020801-001 | Sep 24, 1998 | See Plans and Pricing | See Plans and Pricing |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | See Plans and Pricing | See Plans and Pricing |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020902-001 | Aug 5, 1999 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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