RIFABUTIN Drug Patent Profile
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When do Rifabutin patents expire, and what generic alternatives are available?
Rifabutin is a drug marketed by Lupin Ltd and Novitium Pharma and is included in two NDAs.
The generic ingredient in RIFABUTIN is rifabutin. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rifabutin
A generic version of RIFABUTIN was approved as rifabutin by LUPIN LTD on February 24th, 2014.
Summary for RIFABUTIN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 90 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| Tuberculosis Trials Consortium | Phase 2/Phase 3 |
| CW-Research and Management GmbH | Phase 1 |
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novitium Pharma | RIFABUTIN | rifabutin | CAPSULE;ORAL | 215041-001 | Dec 17, 2021 | AB | RX | 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 |
