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SIMVASTATIN; SITAGLIPTIN PHOSPHATE | N202343 | MERCK SHARP AND DOHME CORP

6 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)IPRPTAB Challenge

Today

7326708

Oct. 11, 2026IPR×4

PTAB Proceedings

4 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2020-01045	7326708	IPR	Teva Pharmaceuticals USA, Inc.	Terminated-Settled	2020-06-10	—
IPR2020-00040	7326708	IPR	Mylan Pharmaceuticals, Inc.	Final Written Decision	2019-10-30	2023-09-06
IPR2020-01060	7326708	IPR	Dr. Reddy's Laboratories, Inc. et al.	Final Written Decision	2020-06-11	—
IPR2020-01072	7326708	IPR	Sun Pharmaceutical Industries Ltd. et al.	Final Written Decision	2020-06-12	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2014	SUPPL -11	View Letter (PDF)
Oct 28, 2013	SUPPL -8	View Letter (PDF)
Aug 22, 2013	SUPPL -10	View Letter (PDF)
Feb 13, 2013	SUPPL -6	View Letter (PDF)
Nov 6, 2012	SUPPL -5	View Letter (PDF)
Nov 6, 2012	SUPPL -7	View Letter (PDF)
Sep 24, 2012	SUPPL -2	View Letter (PDF)
Sep 24, 2012	SUPPL -1	View Letter (PDF)
Sep 24, 2012	SUPPL -4	View Letter (PDF)
Oct 7, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Oct 7, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7326708	Apr 11, 2026PED: Oct 11, 2026	PED	Yes	Yes		—

#002 — 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Oct 7, 2011

#003 — 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Oct 7, 2011

#004 — 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Sep 18, 2012

#005 — 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Sep 18, 2012

#006 — 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Sep 18, 2012