RIFABUTIN - Generic Drug Details
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What are the generic sources for rifabutin and what is the scope of freedom to operate?
Rifabutin
is the generic ingredient in two branded drugs marketed by Pfizer, Lupin Ltd, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for rifabutin. Five suppliers are listed for this compound.
Summary for RIFABUTIN
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 90 |
Patent Applications: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for RIFABUTIN |
What excipients (inactive ingredients) are in RIFABUTIN? | RIFABUTIN excipients list |
DailyMed Link: | RIFABUTIN at DailyMed |
Recent Clinical Trials for RIFABUTIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CW-Research and Management GmbH | Phase 1 |
Tuberculosis Trials Consortium | Phase 2/Phase 3 |
Gilead Sciences | Phase 1 |
Pharmacology for RIFABUTIN
Drug Class | Rifamycin Antimycobacterial |
Medical Subject Heading (MeSH) Categories for RIFABUTIN
Anatomical Therapeutic Chemical (ATC) Classes for RIFABUTIN
US Patents and Regulatory Information for RIFABUTIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | RIFABUTIN | rifabutin | CAPSULE;ORAL | 090033-001 | Feb 24, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novitium Pharma | RIFABUTIN | rifabutin | CAPSULE;ORAL | 215041-001 | Dec 17, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Pfizer | MYCOBUTIN | rifabutin | CAPSULE;ORAL | 050689-001 | Dec 23, 1992 | AB | RX | Yes | Yes | ⤷ 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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