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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension NCT01012479	Phase 4	Completed	Takeda	107	2009-10 → 2010-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$1.14

per ea

Lowest NADAC/Unit

$0.9736

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559066290CANDESARTAN-HYDROCHLOROTHIAZIDE 32-25 MG TAB	$1.14	EA	Generic	—	2026-06-17
62559066190CANDESARTAN-HYDROCHLOROTHIAZIDE 32-12.5 MG TB	$1.06	EA	Generic	—	2026-06-17
62559066090CANDESARTAN-HYDROCHLOROTHIAZIDE 16-12.5 MG TB	$0.9736	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$19.43

Highest Price

$898.16

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0650-90ATACAND HCT 16MG/12.5MG TAB	$727.96	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0650-90ATACAND HCT 16MG/12.5MG TAB	$535.10	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0660-90CANDESARTAN CILEXETIL 16MG/HCTZ 12.5MG TAB	$25.07	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0660-90CANDESARTAN CILEXETIL 16MG/HCTZ 12.5MG TAB	$19.43	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0651-90ATACAND HCT 32MG/12.5MG TAB	$791.98	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0651-90ATACAND HCT 32MG/12.5MG TAB	$581.91	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Atacand HCT (2024)

Total Spending

$512K

Total Claims

852

Beneficiaries

193

Avg Cost/Unit

$9.32

Spending Trend

$898K(2019)→$974K(2020)→$830K(2021)→$719K(2022)→$609K(2023)→$512K(2024)

YoY Change:-2.4%

5yr CAGR:+2.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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