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SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

ANDA

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | A205981 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB v. Mylan Pharmaceuticals Inc. 1:2014cv00094 3 patentsANDA 205980, 205981saxagliptin hydrochloride; saxagliptin hydrochloride and metformin hydrochloride	WVND	2014-06-03	Terminated 2017-03-10	—
AstraZeneca AB v. Mylan Pharmaceuticals Inc. 1:2014cv00696 4 patentsANDA 205980, 205981saxagliptin hydrochloride; saxagliptin hydrochloride and metformin hydrochloride	D. Del.	2014-06-02	Terminated 2017-02-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 21, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — 500MG;EQ 5MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 31, 2023

No patent or exclusivity listings for this strength.

#002 — 1GM;EQ 2.5MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 31, 2023

#003 — 1GM;EQ 5MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 31, 2023