Viewing data from:

KOMBIGLYZE XR

NDA

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | N200678 | ASTRAZENECA AB

3 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

Today

M-14

Oct. 11, 2027

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

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).

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 Kombiglyze XR (2023)

Total Spending

$19.5M

Total Claims

21,381

Beneficiaries

5,089

Avg Cost/Unit

$11.90

Spending Trend

$55.6M(2019)→$39.5M(2020)→$35.4M(2021)→$28.3M(2022)→$19.5M(2023)

YoY Change:+3.8%

5yr CAGR:+3.9%

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2024	SUPPL -28	View Letter (PDF)
Jul 2, 2019	SUPPL -24	View Letter (PDF)
Mar 8, 2017	SUPPL -18	View Letter (PDF)
Jan 24, 2017	SUPPL -20	View Letter (PDF)
Jan 24, 2017	SUPPL -19	View Letter (PDF)
Apr 7, 2016	SUPPL -13	View Letter (PDF)
Sep 1, 2015	SUPPL -16	View Letter (PDF)
May 28, 2013	SUPPL -10	View Letter (PDF)
Apr 5, 2012	SUPPL -7	View Letter (PDF)
Mar 13, 2012	SUPPL -4	View Letter (PDF)
Mar 13, 2012	SUPPL -3	View Letter (PDF)
Nov 21, 2011	SUPPL -5	View Letter (PDF)
Nov 12, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents1 exclusivity▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 5, 2010

Exclusivities (1)

Code	Date	Status
M-14	Oct 11, 2027	Active

#002 — 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 5, 2010

#003 — 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 5, 2010