CANDESARTAN CILEXETIL Drug Patent Profile

Which patents cover Candesartan Cilexetil, and what generic alternatives are available?

Candesartan Cilexetil is a drug marketed by Alembic, Apotex, Macleods Pharms Ltd, Mylan, Prinston Inc, Zydus Lifesciences, Apotex Inc, and Dr Reddys Labs Ltd. and is included in thirteen NDAs.

The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Candesartan Cilexetil

A generic version of CANDESARTAN CILEXETIL was approved as candesartan cilexetil; hydrochlorothiazide by MYLAN on December 4^th, 2012.

Summary for CANDESARTAN CILEXETIL

US Patents:	0
Applicants:	8
NDAs:	13
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	68
Patent Applications:	4,164
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CANDESARTAN CILEXETIL
What excipients (inactive ingredients) are in CANDESARTAN CILEXETIL?	CANDESARTAN CILEXETIL excipients list
DailyMed Link:	CANDESARTAN CILEXETIL at DailyMed

See drug prices for CANDESARTAN CILEXETIL

Recent Clinical Trials for CANDESARTAN CILEXETIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Francisco	Phase 2
United States Department of Defense	Phase 2
The George Institute for Global Health, India	Phase 2

See all CANDESARTAN CILEXETIL clinical trials

Pharmacology for CANDESARTAN CILEXETIL

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CANDESARTAN CILEXETIL

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for CANDESARTAN CILEXETIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND	Tablets	candesartan cilexetil	4 mg, 8 mg, 16 mg and 32 mg	020838	1	2006-12-22

US Patents and Regulatory Information for CANDESARTAN CILEXETIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	203466-003	Nov 27, 2017	AB	RX	No	No
Macleods Pharms Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	204100-003	Feb 27, 2015	AB	RX	No	No
Dr Reddys Labs Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	202965-002	Jun 3, 2013	AB	RX	No	No
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-001	Dec 4, 2012	AB	RX	No	No
Dr Reddys Labs Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	202965-003	Jun 3, 2013	AB	RX	No	No
Alembic	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	210302-001	Dec 4, 2018	AB	RX	No	No
Prinston Inc	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	206233-002	Aug 21, 2023	AB	RX	No	No