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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 eleven branded drugs marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Novel Labs Inc, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Valeant Pharms North, and Horizon, and is included in sixty-eight NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for famotidine. Ninety suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for famotidine
US Patents: | 7 |
Tradenames: | 11 |
Applicants: | 40 |
NDAs: | 68 |
Drug Master File Entries: | 18 |
Suppliers / Packagers: | 90 |
Bulk Api Vendors: | 70 |
Clinical Trials: | 84 |
Patent Applications: | 7,284 |
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 |
DailyMed Link: | famotidine at DailyMed |
Recent Clinical Trials for famotidine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
drpykessupplements.com | Phase 4 |
Profact, Inc. | Phase 2 |
Reema Padia | Phase 1/Phase 2 |
Generic filers with tentative approvals for FAMOTIDINE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 10MG/ML | Injectable; Injection |
Start Trial | Start Trial | 10MG/ML | Injectable; Injection |
Start Trial | Start Trial | 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
Paragraph IV (Patent) Challenges for FAMOTIDINE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
PEPCID AC | TABLET, CHEWABLE;ORAL | famotidine | 020801 | |
PEPCID | TABLET;ORAL | famotidine | 019462 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Athenex Inc | FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075622-001 | Apr 16, 2001 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Sun Pharm Inds Ltd | FAMOTIDINE | famotidine | TABLET;ORAL | 090283-001 | Nov 17, 2009 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Sandoz | FAMOTIDINE | famotidine | TABLET;ORAL | 075793-001 | Apr 16, 2001 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Salix Pharms | PEPCID | famotidine | FOR SUSPENSION;ORAL | 019527-001 | Feb 2, 1987 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Aurobindo Pharma Ltd | FAMOTIDINE | famotidine | TABLET;ORAL | 206531-002 | Apr 26, 2016 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Wockhardt | FAMOTIDINE | famotidine | TABLET;ORAL | 077146-001 | Mar 7, 2005 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Watson Labs | FAMOTIDINE | famotidine | TABLET;ORAL | 075062-002 | Apr 16, 2001 | DISCN | No | No | Start Trial | Start Trial | 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 famotidine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020325-001 | Apr 28, 1995 | Start Trial | Start Trial |
Ucb Inc | FLUXID | famotidine | TABLET, ORALLY DISINTEGRATING;ORAL | 021712-002 | Sep 24, 2004 | Start Trial | Start Trial |
Merck | PEPCID RPD | famotidine | TABLET, ORALLY DISINTEGRATING;ORAL | 020752-001 | May 28, 1998 | Start Trial | Start Trial |
Ucb Inc | FLUXID | famotidine | TABLET, ORALLY DISINTEGRATING;ORAL | 021712-001 | Sep 24, 2004 | Start Trial | Start Trial |
Salix Pharms | PEPCID | famotidine | FOR SUSPENSION;ORAL | 019527-001 | Feb 2, 1987 | Start Trial | Start Trial |
Valeant Pharms North | PEPCID | famotidine | TABLET;ORAL | 019462-002 | Oct 15, 1986 | Start Trial | Start Trial |
J And J Consumer Inc | PEPCID AC | famotidine | TABLET;ORAL | 020902-001 | Aug 5, 1999 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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