CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - Generic Drug Details

What are the generic sources for candesartan cilexetil; hydrochlorothiazide and what is the scope of freedom to operate?

Candesartan cilexetil; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, and Zydus Lifesciences, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	16
DailyMed Link:	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Takeda	Phase 4
Takeda

See all CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant	Application No.	Strength	Dosage Form
		32MG; 25MG	TABLET; ORAL
		32MG; 12.5MG	TABLET; ORAL
		16MG; 12.5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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; HYDROCHLOROTHIAZIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	32 mg/25 mg	021093	1	2009-03-06
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	16 mg/12.5 mg and 32 mg/12.5 mg	021093	1	2008-06-25

US Patents and Regulatory Information for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-001	Dec 4, 2012	AB	RX	No	No
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-002	Dec 4, 2012	AB	RX	No	No
Dr Reddys Labs Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	202965-001	Jun 3, 2013	AB	RX	No	No
Prinston Inc	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	207455-002	Apr 11, 2018	AB	RX	No	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	AB	RX	Yes	No
Zydus Lifesciences	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	203466-003	Nov 27, 2017	AB	RX	No	No
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-003	Dec 4, 2012	AB	RX	No	No

Expired US Patents for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000