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ATACAND

NDA

CANDESARTAN CILEXETIL | N020838 | ANI PHARMACEUTICALS INC

4 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

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0510 The law firm Hyman, Phelps & McNamara filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 on behalf of a client requesting that FDA declare Candesartan Cilexetil Tablets, 2 mg, suitable for submission as an ANDA, with ANI Pharmace	Suitability	2021-05-26	Granted	Hyman, Phelps & McNamara, P.C.
Attachment 3 - Candesartan Cilexetil PI - HIGHLIGHTS OF PRESCRIBING INFORMATI... FDA-2021-P-0510 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding candesartan cilexetil, requesting FDA consideration of the drug's suitability for approval under the abbreviated new drug application pathway. The petition references proposed prescribing information highlights for the angiotensin	Suitability	2021-05-26	Granted	Hyman, Phelps & McNamara, P.C.
Attachment 2 - ATACAND PI - ATACAND- candes artan cilexetil tablet RE Suitabi... FDA-2021-P-0510 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding ATACAND (candesartan cilexetil) tablets, requesting FDA evaluation of the product's suitability for approval or related regulatory action.	Suitability	2021-05-26	Granted	Hyman, Phelps & McNamara, P.C.
Attachment 1 - ATACAND - Prescription Drug Product List RE Suitability Petiti... FDA-2021-P-0510 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Atacand (candesartan cilexetil), a prescription drug product, requesting that the FDA determine the suitability of the drug for inclusion on the Prescription Drug Product List.	Suitability	2021-05-26	Granted	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

24 trials from ClinicalTrials.gov, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)NCT00690612	Phase 3	Completed	AstraZeneca	35	2007-09 → 2009-09
Bioequivalence Study in Healthy Subjects NCT00844324	Phase 1	Completed	AstraZeneca	36	2009-03 → 2009-06
Diabetic Retinopathy Candesartan Trials NCT00252733	Phase 3	Completed	AstraZeneca	5,238	2001-06 → 2008-04
Clinical Trial to Compare the Pharmacokinetics of DP-R208 NCT02707224	Phase 1	Completed	Alvogen Korea	40	2015-01 → 2015-06
Bioavailability Study of Candesartan Cilexetil 16mg Tablet Under Fasting Conditions NCT02006602	Phase 1	Completed	GlaxoSmithKline	16	2013-12-13 → 2014-01-22
The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension NCT01135212	Phase 3	Completed	Boryung Pharmaceutical Co., Ltd	290	2010-04 → 2011-05
A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323 NCT02094924	Phase 1	Completed	GlaxoSmithKline	16	2014-04-17 → 2014-05-23
Scandinavian Candesartan Acute Stroke Trial (SCAST)NCT00120003	Phase 3	Completed	Ullevaal University Hospital	2,500	2005-06 → 2010-09
Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine NCT01613209	Phase 3	Completed	Institut für Pharmakologie und Präventive Medizin	83	2011-12 → 2012-10
Prophylactic Treatment of Episodic Cluster Headache NCT00184587	Phase 2	Completed	Norwegian University of Science and Technology	40	2005-03 → 2009-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs

Highest NADAC/Unit

$9.90

per ea

Lowest NADAC/Unit

$7.85

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559064330ATACAND 32 MG TABLET	$9.90	EA	Brand	$0.5530	2026-10-21
62559064390ATACAND 32 MG TABLET	$9.90	EA	Brand	$0.5530	2026-10-21
62559064230ATACAND 16 MG TABLET	$7.85	EA	Brand	$0.4980	2026-07-22
62559064290ATACAND 16 MG TABLET	$7.85	EA	Brand	$0.4980	2026-07-22

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

$133.29

Highest Price

$880.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0640-30ATACAND 4MG TAB	$133.29	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0640-30ATACAND 4MG TAB	$180.49	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0641-30ATACAND 8MG TAB	$158.58	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0641-30ATACAND 8MG TAB	$215.77	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0642-30ATACAND 16MG TAB	$163.51	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0642-30ATACAND 16MG TAB	$232.01	FSS	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 (2024)

Total Spending

$1.8M

Total Claims

2,894

Beneficiaries

649

Avg Cost/Unit

$8.66

Spending Trend

$3.0M(2019)→$3.1M(2020)→$2.6M(2021)→$2.2M(2022)→$2.0M(2023)→$1.8M(2024)

YoY Change:-3.9%

5yr CAGR:+1.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs12 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

ZYDUS LIFESCIENCES LTDCANDESARTAN CILEXETIL USP

DMF 188282005

MATRIX PHARMACORP PRIVATE LTDCANDESARTAN CILEXETIL USP

DMF 204002007

TORRENT PHARMACEUTICALS LTDCANDESARTAN CILEXETIL

DMF 226722009

ZYDUS LIFESCIENCES LTDCANDESARTAN CILEXETIL USP

DMF 236932010

MACLEODS PHARMACEUTICALS LTDCANDESARTAN CILEXETIL

DMF 248102011

ULKAR KIMYA SANAYII VE TICARET ASCANDESARTAN CILEXETIL

DMF 252162011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCANDESARTAN CILEXETIL USP

DMF 254552011

CHROMO LABORATORIES INDIA PRIVATE LTDCANDESARTAN CILEXETIL USP

DMF 257972012

ULKAR KIMYA SANAYII VE TICARET ASCANDESARTAN CILEXETIL USP

DMF 269962013

ALEMBIC PHARMACEUTICALS LTDCANDESARTAN CILEXETIL USP (CND PROCESS)

DMF 302402016

ZHUHAI RUNDU PHARMACEUTICAL CO LTDCANDESARTAN CILEXETIL NON-STERILE BULK DRUG SUBSTANCE

DMF 374682022

DR REDDYS LABORATORIES LTDInactiveCANDESARTAN CILEXETIL USP

DMF 199902006

LEK PHARMACEUTICALS DDInactiveCANDESARTAN CILEXETIL

DMF 200532006

RANBAXY LABORATORIES LTDInactiveCANDESARTAN CILEXETIL (NON STERILE BULK) DRUG SUBSTANCE

DMF 200912006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCANDESARTAN CILEXETIL

DMF 210692007

JUBILANT PHARMOVA LTDInactiveCANDESARTAN CILEXETIL USP

DMF 213742008

ALEMBIC PHARMACEUTICALS LTDInactiveCANDESARTAN CILEXETIL

DMF 215072008

JIANGXI SYNERGY PHARMACEUTICAL CO LTDInactiveCANDESARTAN CILEXETIL

DMF 236492010

UNIMARK REMEDIES LTDInactiveCANDESARTAN CILEXETIL

DMF 237752010

APOTEX PHARMACHEM INDIA PVT LTDInactiveCANDESARTAN CILEXETIL USP

DMF 239412010

AUROBINDO PHARMA LTDInactiveCANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE)

DMF 242962010

HETERO LABS LTDInactiveCANDESARTAN CILEXETIL

DMF 247702011

PARABOLIC DRUGS LTDInactiveCANDESARTAN CILEXETIL

DMF 252192011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jun 25, 2020	SUPPL -41	View Letter (PDF)
Feb 11, 2016	SUPPL -39	View Letter (PDF)
Feb 10, 2015	SUPPL -36	View Letter (PDF)
Apr 30, 2013	SUPPL -38	View Letter (PDF)
May 2, 2012	SUPPL -35	View Letter (PDF)
Apr 16, 2012	SUPPL -32	View Letter (PDF)
Jul 5, 2011	SUPPL -33	View Letter (PDF)
Nov 5, 2009	SUPPL -31	View Letter (PDF)
Aug 21, 2006	SUPPL -26	View Letter (PDF)
May 20, 2005	SUPPL -22	View Letter (PDF)
Feb 23, 2005	SUPPL -24	View Letter (PDF)
Dec 30, 2004	SUPPL -23	View Letter (PDF)
May 27, 2004	SUPPL -17	View Letter (PDF)
May 29, 2003	SUPPL -19	View Letter (PDF)
Sep 13, 2002	SUPPL -15	View Letter (PDF)
Jun 4, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 4MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 4, 1998

No patent or exclusivity listings for this strength.

#002 — 8MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 4, 1998

#003 — 16MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 4, 1998

#004 — 32MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 4, 1998