Candesartan cilexetil - Generic Drug Details

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

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

There are twenty-two drug master file entries for candesartan cilexetil. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for candesartan cilexetil

US Patents:	0
Tradenames:	4
Applicants:	9
NDAs:	15
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	68
Patent Applications:	6,692
Drug Prices:	Drug price trends 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
United States Department of Defense	Phase 2
University of California, San Francisco	Phase 2
University of Sydney	Phase 2

See all candesartan cilexetil clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	32MG; 25MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	32MG; 12.5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	202884-003	Jun 3, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	203813-001	Dec 5, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	206233-003	Aug 21, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for candesartan cilexetil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	⤷ Sign Up	⤷ Sign Up
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	⤷ Sign Up	⤷ Sign Up
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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