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Profile for Tradename: ONGLYZA

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Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

Summary for Tradename: ONGLYZA

Patents:2
Applicants:1
NDAs:1
Suppliers: see list4

Pharmacology for Tradename: ONGLYZA

Clinical Trials for: ONGLYZA

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

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 the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
Status: Completed Condition: Diabetes Mellitus

Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants
Status: Completed Condition: Type 2 Diabetes Mellitus

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
Status: Completed Condition: Diabetes Mellitus

BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Status: Withdrawn Condition: Type 2 Diabetes

The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes
Status: Active, not recruiting Condition: Type 1 Diabetes

A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Status: Completed Condition: Diabetes

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350Jul 31, 2009RXYes<disabled><disabled>
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350Jul 31, 2009RXNo<disabled><disabled>
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350Jul 31, 2009RXYes<disabled><disabled>
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350Jul 31, 2009RXNoRE44186<disabled>YY<disabled>
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350Jul 31, 2009RXYes7,951,400<disabled>Y<disabled>
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Paragraph IV activity for: ONGLYZA

Drugname Dosage Strength RLD Submissiondate
saxagliptin hydrochlorideTablets2.5 mg and 5 mgOnglyza7/31/2013
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