NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details
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What are the generic sources for nitrofurantoin, macrocrystalline and what is the scope of freedom to operate?
Nitrofurantoin, macrocrystalline
is the generic ingredient in three branded drugs marketed by Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.Twenty-eight suppliers are listed for this compound.
Summary for NITROFURANTOIN, MACROCRYSTALLINE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 11 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 28 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 3 |
| Patent Applications: | 6,478 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NITROFURANTOIN, MACROCRYSTALLINE at DailyMed |
Recent Clinical Trials for NITROFURANTOIN, MACROCRYSTALLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Saltro | Phase 3 |
| MJM Bonten | Phase 3 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 3 |
Pharmacology for NITROFURANTOIN, MACROCRYSTALLINE
| Drug Class | Nitrofuran Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN, MACROCRYSTALLINE
US Patents and Regulatory Information for NITROFURANTOIN, MACROCRYSTALLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Almatica | MACRODANTIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 016620-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | NITROFURANTOIN MACROCRYSTALLINE | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 070249-001 | Jun 24, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Athem | NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 074336-002 | Jan 25, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mankind Pharma | NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 217272-001 | Mar 21, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | NITROFURANTOIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 211935-001 | Jun 25, 2021 | AB | RX | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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