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Amlodipine besylate; hydrochlorothiazide; valsartan - Generic Drug Details

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Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Teva Pharms, Par Pharm, Torrent Pharms Ltd, and Lupin Ltd, and is included in five NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and fourteen patent family members in thirty-six countries.

There are forty-eight drug master file entries for amlodipine besylate; hydrochlorothiazide; valsartan. Eight suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; hydrochlorothiazide; valsartan

Tradenames:2
Patents:3
Applicants:5
NDAs:5
Drug Master File Entries: see list48
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Clinical Trials for: amlodipine besylate; hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 2009RXYes6,294,197*PED<disabled>Y<disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 2009RXYes8,475,839*PED<disabled>Y<disabled>
Par Pharm
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL201087-004Jun 1, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 20095,399,578*PED<disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 20095,399,578*PED<disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-002Apr 30, 20095,399,578*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,858,228 Solid oral dosage forms of valsartan<disabled in preview>
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
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International Patent Family for Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
Peru04392004<disabled in preview>
China1232394<disabled in preview>
Russian Federation2324482<disabled in preview>
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Supplementary Protection Certificates for Tradename: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00528Netherlands<disabled>PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
12/018Ireland<disabled>PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
00478Netherlands<disabled>PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
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