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Serving leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
Dow
Julphar
Cerilliant
Teva
QuintilesIMS
Chubb
UBS
US Army

Generated: January 19, 2018

DrugPatentWatch Database Preview

Hydrochlorothiazide; telmisartan - Generic Drug Details

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

Hydrochlorothiazide; telmisartan
is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, 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; telmisartan has forty-seven patent family members in thirty-five countries.

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

US Patents and Regulatory Information for hydrochlorothiazide; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 201192-001 Feb 25, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-002 Aug 15, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Macleods Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204169-001 Nov 2, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010-001 Feb 25, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010-003 Feb 25, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Macleods Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204169-002 Nov 2, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-003 Aug 15, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010-002 Feb 25, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-002 Dec 15, 2016 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; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for hydrochlorothiazide; telmisartan

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
6,410,742 Polymorphs of telmisartan ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for hydrochlorothiazide; telmisartan

Supplementary Protection Certificates for hydrochlorothiazide; telmisartan

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:

Accenture
McKinsey
Healthtrust
Express Scripts
Daiichi Sankyo
Moodys
Colorcon
Baxter
Chinese Patent Office

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