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Glyburide - Generic Drug Details
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What are the generic sources for glyburide and what is the scope of patent protection?
Glyburide
is the generic ingredient in seven branded drugs marketed by Sanofi Aventis Us, Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Orient Pharma Co Ltd, Swiss Pharm, Teva, Zydus Pharms, Dava Pharms Inc, Hikma, Mylan, Yaopharma Co Ltd, Pharmacia And Upjohn, and Bristol Myers Squibb, and is included in twenty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for glyburide. Twenty-seven suppliers are listed for this compound.
Summary for glyburide
US Patents: | 1 |
Tradenames: | 7 |
Applicants: | 17 |
NDAs: | 27 |
Drug Master File Entries: | 20 |
Suppliers / Packagers: | 27 |
Bulk Api Vendors: | 124 |
Clinical Trials: | 65 |
Patent Applications: | 6,951 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for glyburide |
Drug Sales Revenues: | Drug sales revenues for glyburide |
What excipients (inactive ingredients) are in glyburide? | glyburide excipients list |
DailyMed Link: | glyburide at DailyMed |
Recent Clinical Trials for glyburide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ironwood Pharmaceuticals, Inc. | Phase 1 |
Medical College of Wisconsin | Phase 4 |
The University of Texas Health Science Center, Houston | Phase 4 |
Pharmacology for glyburide
Drug Class | Sulfonylurea |
Medical Subject Heading (MeSH) Categories for glyburide
US Patents and Regulatory Information for glyburide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva | GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686-001 | Apr 20, 1999 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Epic Pharma Llc | GLYBURIDE | glyburide | TABLET;ORAL | 076257-001 | Jun 27, 2002 | AB1 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Heritage Pharms Inc | GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 079009-003 | Jun 3, 2009 | DISCN | No | No | 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 |
Expired US Patents for glyburide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pharmacia And Upjohn | GLYNASE | glyburide | TABLET;ORAL | 020051-002 | Mar 4, 1992 | Start Trial | Start Trial |
Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | Start Trial | Start Trial |
Pharmacia And Upjohn | GLYNASE | glyburide | TABLET;ORAL | 020051-001 | Mar 4, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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