Viewing data from:

ATACAND HCT

NDA

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | N021093 | ANI 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

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 Atacand HCT (2023)

Total Spending

$609K

Total Claims

1,002

Beneficiaries

218

Avg Cost/Unit

$9.55

Spending Trend

$898K(2019)→$974K(2020)→$830K(2021)→$719K(2022)→$609K(2023)

YoY Change:+8.8%

5yr CAGR:+5.2%

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Aug 24, 2020	SUPPL -21	View Letter (PDF)
Feb 11, 2016	SUPPL -19	View Letter (PDF)
Feb 10, 2015	SUPPL -16	View Letter (PDF)
Apr 30, 2013	SUPPL -18	View Letter (PDF)
Apr 2, 2012	SUPPL -15	View Letter (PDF)
Jun 17, 2011	SUPPL -13	View Letter (PDF)
Mar 16, 2011	SUPPL -12	View Letter (PDF)
May 20, 2008	SUPPL -8	View Letter (PDF)
Aug 18, 2006	SUPPL -6	View Letter (PDF)
Dec 30, 2004	SUPPL -4	View Letter (PDF)
Sep 5, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 16MG;12.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 5, 2000

No patent or exclusivity listings for this strength.

#002 — 32MG;12.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 5, 2000

#003 — 32MG;25MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 16, 2008