CANDESARTAN CILEXETIL Drug Patent Profile
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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 4th, 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 |
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 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Macleods Pharms Ltd | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 204100-003 | Feb 27, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys Labs Ltd | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 202965-002 | Jun 3, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |