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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Department of Justice
Covington
Colorcon
Moodys
Federal Trade Commission
AstraZeneca
Deloitte
Johnson and Johnson

Generated: October 23, 2018

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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 patent protection?

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.

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

Summary for hydrochlorothiazide; telmisartan
Pharmacology for hydrochlorothiazide; telmisartan
Synonyms for hydrochlorothiazide; telmisartan
(1,1'-Biphenyl)-2-carboxylic acid, 4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H- benzimidazol)-1'-yl)methyl)-, mixt. with 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide
4'-[(1,7'-dimethyl-2'-propyl-1h,3'h-2,5'-bibenzimidazol-3'-yl)methyl]biphenyl-2-carbons
485391-74-0
AC1L50G0
AC1Q5U7Q
BAY 98-7103
BAY98-7103
C33H30N4O2.C7H8ClN3O4S2
HE345084
Hydrochlorothiazide mixture with Telmisartan
Hydrochlorothiazide/telmisartan mixt.
Kinzalkomb
LS-178585
MicardisPlus
PritorPlus
SCHEMBL2516314
Telma-H
Telmisartan and hydrochlorothiazide
Telmisartan-Hydrochlorothiazide
telmisartan, hydrochlorothiazide drug combination
Telmisartan/hydrochlorothiazide mixt.
Telsar-H

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-001 Aug 15, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-001 Dec 15, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Prinston Inc TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 209028-003 Nov 6, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 091351-002 Aug 7, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-002 Dec 15, 2016 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

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

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Supplementary Protection Certificates for hydrochlorothiazide; telmisartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0025 Belgium ➤ Sign Up PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
00095 Netherlands ➤ Sign Up PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
C0030 France ➤ Sign Up PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
C/GB99/008 United Kingdom ➤ Sign Up 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
2011 00026 Denmark ➤ Sign Up 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 ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Department of Justice
Covington
Colorcon
Moodys
Federal Trade Commission
AstraZeneca
Deloitte
Johnson and Johnson

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