MACRODANTIN Drug Patent Profile
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When do Macrodantin patents expire, and when can generic versions of Macrodantin launch?
Macrodantin is a drug marketed by Almatica and is included in one NDA.
The generic ingredient in MACRODANTIN is nitrofurantoin, macrocrystalline. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin, macrocrystalline profile page.
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Questions you can ask:
- What is the 5 year forecast for MACRODANTIN?
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- What is Average Wholesale Price for MACRODANTIN?
Summary for MACRODANTIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 6 |
| Patent Applications: | 5,701 |
| Drug Prices: | Drug price information for MACRODANTIN |
| What excipients (inactive ingredients) are in MACRODANTIN? | MACRODANTIN excipients list |
| DailyMed Link: | MACRODANTIN at DailyMed |
Recent Clinical Trials for MACRODANTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roswell Park Cancer Institute | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
| European Commission | Phase 4 |
Pharmacology for MACRODANTIN
| Drug Class | Nitrofuran Antibacterial |
US Patents and Regulatory Information for MACRODANTIN
| 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 | 016620-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Almatica | MACRODANTIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 016620-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Almatica | MACRODANTIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 016620-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ 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 |



