AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - Generic Drug Details
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What are the generic drug sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of patent protection?
Amlodipine besylate; hydrochlorothiazide; valsartan
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Lupin Ltd, Strides Pharma, Teva Pharms, Torrent, and Novartis, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.Four suppliers are listed for this compound.
Summary for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
DailyMed Link: | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN at DailyMed |
Pharmacology for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Drug Class | Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXFORGE HCT | Tablets | amlodipine besylate; hydrochlorothiazide; valsartan | 10 mg/12.5 mg/ 160 mg | 022314 | 1 | 2009-10-22 |
EXFORGE HCT | Tablets | amlodipine besylate; hydrochlorothiazide; valsartan | 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg | 022314 | 1 | 2009-09-14 |
US Patents and Regulatory Information for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Strides Pharma | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 201087-003 | Jun 1, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Torrent | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 201593-003 | Jun 3, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Strides Pharma | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 201087-002 | Jun 1, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 201087-005 | Jun 1, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 200435-001 | Sep 25, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 206180-001 | Dec 19, 2017 | 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 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-003 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-005 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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