ATACAND HCT Drug Patent Profile
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When do Atacand Hct patents expire, and what generic alternatives are available?
Atacand Hct is a drug marketed by Ani Pharms and is included in one NDA.
The generic ingredient in ATACAND HCT 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 Atacand Hct
A generic version of ATACAND HCT was approved as candesartan cilexetil; hydrochlorothiazide by MYLAN on December 4th, 2012.
Summary for ATACAND HCT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 46 |
Patent Applications: | 7 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ATACAND HCT |
What excipients (inactive ingredients) are in ATACAND HCT? | ATACAND HCT excipients list |
DailyMed Link: | ATACAND HCT at DailyMed |
Recent Clinical Trials for ATACAND HCT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The University of Texas Health Science Center, Houston | Early Phase 1 |
AgoneX Biopharmaceuticals, Inc. | Phase 2 |
BioHealthonomics Inc. | Phase 2 |
Pharmacology for ATACAND HCT
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 ATACAND HCT
Paragraph IV (Patent) Challenges for ATACAND HCT
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 ATACAND HCT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-003 | May 16, 2008 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for ATACAND HCT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ATACAND HCT
See the table below for patents covering ATACAND HCT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2514282 | ⤷ Try a Trial | |
Poland | 168958 | ⤷ Try a Trial | |
China | 1058966 | ⤷ Try a Trial | |
Finland | 20030210 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ATACAND HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0459136 | SZ 8/1998 | Austria | ⤷ Try a Trial | |
0459136 | SPC/GB97/018 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CANDESARTAN CILEXETIL OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK PL0017/0383 19970429; UK PL0017/0384 19970429; UK PL0017/0385 19970429; UK PL0017/0391 19970429; UK PL15561/0003 19970429; UK PL15661/0001 19970429; UK PL15661/0002 19970429; UK PL15661/0004 19970429 |
0459136 | 98C0016 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 19970429 |
0459136 | 19875004 | Germany | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFF DES ARZNEIMITTELS BLOPRESS BZW. DES ARZNEIMITTELS ATACAND IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; NAT. REGISTRATION NO/DATE: 41261.00.00 41261.01.00 41261.02.00 41261.03.00 41294.00.00 41294.01.00 41294.02.00 41294.03.00 19971203 FIRST REGISTRATION: GROSSBRITANNIEN 15661/0001 15661/0002 15661/0003 15661/0004 19970429 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |