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MICARDIS HCT

NDA

HYDROCHLOROTHIAZIDE; TELMISARTAN | N021162 | BOEHRINGER INGELHEIM

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

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

Medicare Part D Spending

CMS annual spending data for Micardis HCT (2023)

Total Spending

$947K

Total Claims

3,248

Beneficiaries

674

Avg Cost/Unit

$4.71

Spending Trend

$2.5M(2019)→$2.0M(2020)→$1.8M(2021)→$1.1M(2022)→$947K(2023)

YoY Change:-1.6%

5yr CAGR:-9.5%

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
Dec 21, 2022	SUPPL -47	View Letter (PDF)
Aug 21, 2020	SUPPL -45	View Letter (PDF)
Feb 2, 2018	SUPPL -40	View Letter (PDF)
Jan 14, 2016	SUPPL -32	View Letter (PDF)
Dec 15, 2014	SUPPL -37	View Letter (PDF)
Oct 26, 2012	SUPPL -35	View Letter (PDF)
Jan 23, 2012	SUPPL -34	View Letter (PDF)
Jan 23, 2012	SUPPL -30	View Letter (PDF)
May 6, 2011	SUPPL -29	View Letter (PDF)
May 6, 2011	SUPPL -31	View Letter (PDF)
Nov 25, 2009	SUPPL -20	View Letter (PDF)
Nov 25, 2009	SUPPL -19	View Letter (PDF)
Mar 6, 2007	SUPPL -16	View Letter (PDF)
Sep 8, 2005	SUPPL -8	View Letter (PDF)
Apr 29, 2004	SUPPL -5	View Letter (PDF)
Nov 17, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 12.5MG;40MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 17, 2000

No patent or exclusivity listings for this strength.

#002 — 12.5MG;80MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 17, 2000

#003 — 25MG;80MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 19, 2004