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. Five 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.
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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: | 6 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-003 | May 16, 2008 | AB | RX | Yes | Yes | ⤷ 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 ATACAND HCT
| 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 |
| Ani Pharms | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >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 | 3057471 | ⤷ Sign Up | |
| China | 1047518 | ⤷ Sign Up | |
| Austria | 277602 | ⤷ Sign Up | |
| Japan | 2682353 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ATACAND HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0459136 | 8/1998 | Austria | ⤷ Sign Up | PRODUCT NAME: CANDESARTAN CILEXETIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-22232, 1-22233, 1-22235, 1-22236 19971119; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429 |
| 0459136 | 19875004 | Germany | ⤷ Sign Up | 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 |
| 0459136 | C970044 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CANDESARTAN, DESGENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF VAN DE 1-(CYCLOHEXYLOXYCARBONYLOXY) ETHYLESTE R, IN HET BIJZONDER CILEXETILI CANDESARTANAS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 21703 - RVG 21706 19971013; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429 |
| 0459136 | 98C0016 | Belgium | ⤷ Sign Up | PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 19970429 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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