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SAXAGLIPTIN

ANDA

SAXAGLIPTIN HYDROCHLORIDE | A205980 | MYLAN PHARMACEUTICALS INC

2 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	N.D. W. Va.	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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$1.18

per ea

Lowest NADAC/Unit

$1.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378470577SAXAGLIPTIN HCL 2.5 MG TABLET	$1.18	EA	Generic	—	2026-06-17
00378470593SAXAGLIPTIN HCL 2.5 MG TABLET	$1.18	EA	Generic	—	2026-06-17
00378470677SAXAGLIPTIN HCL 5 MG TABLET	$1.12	EA	Generic	—	2026-06-17
00378470693SAXAGLIPTIN HCL 5 MG TABLET	$1.12	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain16 active DMFs3 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDSAXAGLIPTIN MONOHYDRATE

DMF 269772013

WOCKHARDT BIO AGSAXAGLIPTIN HYDROCHLORIDE

DMF 270832013

APITORIA PHARMA PRIVATE LTDSAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)

DMF 271112013

MATRIX PHARMACORP PRIVATE LTDSAXAGLIPTIN HYDROCHLORIDE

DMF 271462013

TAPI NL BVSAXAGLIPTIN MONOHYDRATE

DMF 271742013

RAKS PHARMA PVT LTDSAXAGLIPTIN HYDROCHLORIDE DIHYDRATE

DMF 271892013

DR REDDYS LABORATORIES LTDSAXAGLIPTIN HYDROCHLORIDE

DMF 272122013

MSN PHARMACHEM PRIVATE LTDSAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE) [ROUTE CODE - "SH"]

DMF 272392013

MSN PHARMACHEM PRIVATE LTDSAXAGLIPTIN MONOHYDRATE [ROUTE CODE - SC"]

DMF 273092013

SYNTHETICS CHINA CO LTDSAXAGLIPTIN

DMF 318002017

FUXIN LONG RUI PHARMACEUTICAL CO LTDSAXAGLIPTIN HYDROCHLORIDE

DMF 334862019

MOREPEN LABORATORIES LTDSAXAGLIPTIN HYDROCHLORIDE

DMF 336352019

TAPI NL BVSAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE)

DMF 341652020

MOREPEN LABORATORIES LTDSAXAGLIPTIN HYDROCHLORIDE DIHYDRATE

DMF 356902021

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDSAXAGLIPTIN MONOHYDRATE

DMF 371692022

METROCHEM API PRIVATE LTDSAXAGLIPTIN HYDROCHLORIDE DIHYDRATE

DMF 424922025

MEDICHEM MANUFACTURING (MALTA) LTDInactiveSAXAGLIPTIN HYDROCHLORIDE DIHYDRATE

DMF 269242013

HETERO DRUGS LTDInactiveSAXAGLIPTIN HYDROCHLORIDE PREMIX

DMF 272682013

CIPLA LTDInactiveSAXAGLIPTIN HYDROCHLORIDE

DMF 300542015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 2023