CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - Generic Drug Details
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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 |
⤷ Sign Up | ⤷ Sign Up | 16MG; 12.5MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 32MG; 25MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 32MG; 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Macleods Pharms Ltd | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 204100-002 | Feb 27, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Prinston Inc | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 207455-002 | Apr 11, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Prinston Inc | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 207455-003 | Apr 11, 2018 | 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; HYDROCHLOROTHIAZIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-003 | May 16, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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