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ONGLYZA

NDA

SAXAGLIPTIN HYDROCHLORIDE | N022350 | ASTRAZENECA AB

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

7951400

Nov. 30, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 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	—
AstraZeneca AB v. Aurobindo Pharma Ltd. et al 1:2014cv00664 2 patentsANDA 205972saxagliptin hydrochloride	D. Del.	2014-05-23	Terminated 2017-02-02	—
AstraZeneca AB v. Glenmark Generics Ltd. et al 1:2014cv00665 2 patentsANDA 205994saxagliptin hydrochloride	D. Del.	2014-05-23	Terminated 2015-04-14	—
AstraZeneca AB v. Watson Laboratories Inc. 1:2014cv00666 2 patentsANDA 205902saxagliptin hydrochloride	D. Del.	2014-05-23	Terminated 2015-04-16	—
AstraZeneca AB v. Wockhardt Bio AG et al 1:2014cv00667 2 patentsANDA 206000saxagliptin hydrochloride	D. Del.	2014-05-23	Terminated 2017-02-02	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Onglyza (2023)

Total Spending

$57.8M

Total Claims

63,904

Beneficiaries

15,683

Avg Cost/Unit

$16.47

Spending Trend

$195.0M(2019)→$136.7M(2020)→$119.8M(2021)→$90.5M(2022)→$57.8M(2023)

YoY Change:+3.5%

5yr CAGR:+3.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

13 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2024	SUPPL -26	View Letter (PDF)
Jul 2, 2019	SUPPL -23	View Letter (PDF)
Mar 8, 2017	SUPPL -18	View Letter (PDF)
Jan 24, 2017	SUPPL -19	View Letter (PDF)
Apr 7, 2016	SUPPL -14	View Letter (PDF)
Sep 1, 2015	SUPPL -16	View Letter (PDF)
May 29, 2013	SUPPL -11	View Letter (PDF)
Mar 15, 2012	SUPPL -9	View Letter (PDF)
Dec 22, 2011	SUPPL -4	View Letter (PDF)
Nov 17, 2011	SUPPL -7	View Letter (PDF)
Feb 24, 2011	SUPPL -1	View Letter (PDF)
Feb 24, 2011	SUPPL -2	View Letter (PDF)
Aug 6, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 2009

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7951400	Nov 30, 2028	—	—	Yes	—	—

#002 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 2009