NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) Drug Patent Profile
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When do Nitrofurantoin (monohydrate/macrocrystals) patents expire, and what generic alternatives are available?
Nitrofurantoin (monohydrate/macrocrystals) is a drug marketed by Alvogen, Amneal Pharms, Aurobindo Pharma, Aurobindo Pharma Usa, Inventia, Mankind Pharma, Omsav Pharma, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc. and is included in eleven NDAs.
The generic ingredient in NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 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 (MONOHYDRATE/MACROCRYSTALS)
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) at DailyMed |
-patent-expirations.png "NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) drug patent expirations")
Recent Clinical Trials for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 3 |
| Saltro | Phase 3 |
| MJM Bonten | Phase 3 |
See all NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) clinical trials
Pharmacology for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
| Drug Class | Nitrofuran Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
US Patents and Regulatory Information for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alvogen | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 215002-001 | Jul 20, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Omsav Pharma | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 217073-001 | Nov 3, 2023 | AB | RX | 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 |
