NITROFURANTOIN Drug Patent Profile
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When do Nitrofurantoin patents expire, and what generic alternatives are available?
Nitrofurantoin is a drug marketed by Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novitium Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc. and is included in thirty-nine NDAs.
The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for NITROFURANTOIN
| US Patents: | 0 |
| Applicants: | 25 |
| NDAs: | 39 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 52 |
| Patent Applications: | 6,113 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NITROFURANTOIN |
| What excipients (inactive ingredients) are in NITROFURANTOIN? | NITROFURANTOIN excipients list |
| DailyMed Link: | NITROFURANTOIN at DailyMed |
See drug prices for NITROFURANTOIN
Recent Clinical Trials for NITROFURANTOIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| IBSA Institut Biochimique SA | Phase 4 |
| Goodlife Pharma B.V. | Phase 4 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | NITROFURANTOIN | nitrofurantoin | TABLET;ORAL | 080043-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma | NITROFURANTOIN | nitrofurantoin | SUSPENSION;ORAL | 212607-001 | May 11, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 209225-001 | Mar 30, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Watson Labs | NITROFURANTOIN | nitrofurantoin | TABLET;ORAL | 085796-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Usa | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 076648-001 | Mar 22, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
