NITROFURANTOIN - Generic Drug Details
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What are the generic sources for nitrofurantoin and what is the scope of freedom to operate?
Nitrofurantoin
is the generic ingredient in eight branded drugs marketed by Watson Labs, Casper Pharma Llc, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novel Labs Inc, Novitium Pharma, Procter And Gamble, Chartwell Molecular, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Sun Pharm Industries, Zydus Pharms, Alvogen, Chartwell Rx, Inventia, Micro Labs, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for nitrofurantoin. Eleven suppliers are listed for this compound.
Summary for NITROFURANTOIN
US Patents: | 0 |
Tradenames: | 8 |
Applicants: | 30 |
NDAs: | 45 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 54 |
Patent Applications: | 6,479 |
Drug Prices: | Drug price trends for NITROFURANTOIN |
What excipients (inactive ingredients) are in NITROFURANTOIN? | NITROFURANTOIN excipients list |
DailyMed Link: | NITROFURANTOIN at DailyMed |
Recent Clinical Trials for NITROFURANTOIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Early Phase 1 |
Walter Reed National Military Medical Center | Phase 2 |
Radboud University Medical Center | Phase 4 |
Pharmacology for NITROFURANTOIN
Drug Class | Nitrofuran Antibacterial |
Medical Subject Heading (MeSH) Categories for NITROFURANTOIN
Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN
US Patents and Regulatory Information for NITROFURANTOIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Procter And Gamble | FURADANTIN | nitrofurantoin | TABLET;ORAL | 008693-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mankind Pharma | NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 217272-002 | Mar 21, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Athem | NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 074336-003 | Jan 25, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ranbaxy Labs Ltd | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 076951-001 | Mar 30, 2005 | 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 |
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