Glyburide; metformin hydrochloride - Generic Drug Details
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What are the generic drug sources for glyburide; metformin hydrochloride and what is the scope of freedom to operate?
Glyburide; metformin hydrochloride
is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Actavis Elizabeth, Aurobindo Pharma, Heritage, Impax Labs Inc, Teva, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.Eleven suppliers are listed for this compound.
Summary for glyburide; metformin hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 6 |
Clinical Trials: | 25 |
Patent Applications: | 74 |
DailyMed Link: | glyburide; metformin hydrochloride at DailyMed |
Recent Clinical Trials for glyburide; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The University of Texas Health Science Center, Houston | Phase 4 |
Texas Tech University Health Sciences Center | Phase 3 |
University of Illinois at Chicago | Phase 3 |
Pharmacology for glyburide; metformin hydrochloride
Drug Class | Biguanide Sulfonylurea |
Anatomical Therapeutic Chemical (ATC) Classes for glyburide; metformin hydrochloride
US Patents and Regulatory Information for glyburide; metformin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Impax Labs Inc | GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 076731-001 | Nov 19, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Impax Labs Inc | GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 076731-002 | Nov 19, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Zydus Pharms | GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 206748-002 | Feb 29, 2016 | AB | RX | No | No | ⤷ 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 |
Expired US Patents for glyburide; metformin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | GLUCOVANCE | glyburide; metformin hydrochloride | TABLET;ORAL | 021178-001 | Jul 31, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | GLUCOVANCE | glyburide; metformin hydrochloride | TABLET;ORAL | 021178-003 | Jul 31, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | GLUCOVANCE | glyburide; metformin hydrochloride | TABLET;ORAL | 021178-002 | Jul 31, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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