MYCOBUTIN Drug Patent Profile
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When do Mycobutin patents expire, and when can generic versions of Mycobutin launch?
Mycobutin is a drug marketed by Pfizer and is included in one NDA.
The generic ingredient in MYCOBUTIN 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 Mycobutin
A generic version of MYCOBUTIN was approved as rifabutin by LUPIN LTD on February 24th, 2014.
Summary for MYCOBUTIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 11 |
| Patent Applications: | 4,708 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MYCOBUTIN |
| What excipients (inactive ingredients) are in MYCOBUTIN? | MYCOBUTIN excipients list |
| DailyMed Link: | MYCOBUTIN at DailyMed |
Recent Clinical Trials for MYCOBUTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Bari | Phase 3 |
| Centre for Digestive Diseases, Australia | Phase 2 |
| Cadrock Pty. Ltd. | Phase 2 |
Pharmacology for MYCOBUTIN
| Drug Class | Rifamycin Antimycobacterial |
Anatomical Therapeutic Chemical (ATC) Classes for MYCOBUTIN
US Patents and Regulatory Information for MYCOBUTIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | MYCOBUTIN | rifabutin | CAPSULE;ORAL | 050689-001 | Dec 23, 1992 | AB | RX | Yes | Yes | ⤷ 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 |
