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Serving leading biopharmaceutical companies globally:

Chubb
Dow
Farmers Insurance
Harvard Business School
Medtronic
QuintilesIMS
Boehringer Ingelheim
Federal Trade Commission
Healthtrust
Cantor Fitzgerald

Generated: January 19, 2018

DrugPatentWatch Database Preview

Hydrochlorothiazide; valsartan - Generic Drug Details

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What are the generic sources for hydrochlorothiazide; valsartan and what is the scope of hydrochlorothiazide; valsartan freedom to operate?

Hydrochlorothiazide; valsartan
is the generic ingredient in two branded drugs marketed by Novartis, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Watson Labs Teva, and is included in nine NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrochlorothiazide; valsartan has eighty-seven patent family members in thirty-three countries.

There are thirty-one drug master file entries for hydrochlorothiazide; valsartan. Thirty-one suppliers are listed for this compound.
Summary for hydrochlorothiazide; valsartan
Pharmacology for hydrochlorothiazide; valsartan

US Patents and Regulatory Information for hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946-004 Mar 21, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078020-005 Sep 21, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Macleods Pharms Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203145-001 Apr 19, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs Teva VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 091519-002 Mar 21, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203026-003 Mar 21, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alembic Pharms Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662-001 Mar 21, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078020-002 Sep 21, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078020-001 Sep 21, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for hydrochlorothiazide; valsartan

Non-Orange Book US Patents for 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
6,485,745 Solid oral dosage forms of valsartan ➤ Subscribe
6,858,228 Solid oral dosage forms of valsartan ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for hydrochlorothiazide; valsartan

Supplementary Protection Certificates for hydrochlorothiazide; valsartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011 00026 Denmark ➤ Subscribe PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
C/GB02/037 United Kingdom ➤ Subscribe PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
C0009 Belgium ➤ Subscribe PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
C/GB99/008 United Kingdom ➤ Subscribe PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
C0030 France ➤ Subscribe PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0443983/03 Switzerland ➤ Subscribe PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
00095 Netherlands ➤ Subscribe PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
C0025 Belgium ➤ Subscribe PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
Queensland Health
Farmers Insurance
QuintilesIMS
Express Scripts
US Department of Justice
Dow
Accenture

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