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Profile for Tradename: GLUCOPHAGE

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Glucophage is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug.

The generic ingredient in GLUCOPHAGE is metformin hydrochloride. There are forty-five drug master file entries for this compound. Eight suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for Tradename: GLUCOPHAGE

Suppliers / Packagers: see list5

Pharmacology for Tradename: GLUCOPHAGE

Drug ClassBiguanide

Clinical Trials for: GLUCOPHAGE

Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
Status: Withdrawn Condition: Diabetes Mellitus Type 2

Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Status: Completed Condition: Type 2 Diabetes Mellitus

Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Metformin; Healthy Subjects

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Status: Completed Condition: Healthy Volunteers

Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Status: Completed Condition: Type 2 Diabetes Mellitus

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
Status: Terminated Condition: Diabetes Mellitus, Type 2

Drug-Drug Interaction Study With Metformin and Nizatidine
Status: Completed Condition: Healthy

Metformin And Chloroquine in IDH1/2-mutated Solid Tumors
Status: Recruiting Condition: Glioma; Cholangiocarcinoma; Chondrosarcoma

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
metformin hydrochloride
TABLET;ORAL020357-005Nov 5, 1998RXYes<disabled><disabled>
Bristol Myers Squibb
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021202-001Oct 13, 2000RXNo6,475,521<disabled> <disabled>
Bristol Myers Squibb
metformin hydrochloride
TABLET;ORAL020357-004Nov 5, 1998DISCNNo<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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