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BENICAR HCT

NDA

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | N021532 | COSETTE PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Apotex Inc v. Daiichi Sankyo, Inc. et al 1:2015cv03695 2 patentsANDA 204261olmesartan medoxomil/hydrochlorothiazide	N.D. Ill.	2015-04-27	Terminated 2016-01-08	—

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 Benicar HCT (2023)

Total Spending

$7.3M

Total Claims

10,853

Beneficiaries

2,136

Avg Cost/Unit

$11.78

Spending Trend

$11.0M(2019)→$11.5M(2020)→$9.7M(2021)→$8.0M(2022)→$7.3M(2023)

YoY Change:+11.2%

5yr CAGR:+6.3%

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2025	SUPPL -38	View Letter (PDF)
Aug 21, 2020	SUPPL -37	View Letter (PDF)
Feb 12, 2016	SUPPL -15	View Letter (PDF)
Sep 24, 2014	SUPPL -26	View Letter (PDF)
Jun 30, 2014	SUPPL -25	View Letter (PDF)
Jun 17, 2014	SUPPL -24	View Letter (PDF)
Jul 5, 2013	SUPPL -22	View Letter (PDF)
Dec 11, 2012	SUPPL -21	View Letter (PDF)
Sep 24, 2012	SUPPL -20	View Letter (PDF)
Jan 20, 2012	SUPPL -16	View Letter (PDF)
May 5, 2011	SUPPL -13	View Letter (PDF)
May 5, 2011	SUPPL -14	View Letter (PDF)
Nov 19, 2007	SUPPL -8	View Letter (PDF)
Jul 15, 2005	SUPPL -4	View Letter (PDF)
Nov 16, 2004	SUPPL -1	View Letter (PDF)
Jun 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 12.5MG;20MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 5, 2003

No patent or exclusivity listings for this strength.

#003 — 12.5MG;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 5, 2003

#005 — 25MG;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 5, 2003