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Last Updated: December 12, 2019

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Hydrochlorothiazide; telmisartan - Generic Drug Details

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

Hydrochlorothiazide; telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten 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-two drug master file entries for hydrochlorothiazide; telmisartan. Thirteen suppliers are listed for this compound.

Summary for hydrochlorothiazide; telmisartan
International Patents:47
US Patents:1
Tradenames:2
Applicants:10
NDAs:10
Drug Master File Entries: 32
Suppliers / Packagers: 13
Bulk Api Vendors: 5
Clinical Trials: 47
Patent Applications: 13
DailyMed Link:hydrochlorothiazide; telmisartan at DailyMed
Recent Clinical Trials for hydrochlorothiazide; telmisartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
IlDong Pharmaceutical Co LtdPhase 1
IlDong Pharmaceutical Co LtdPhase 3
Peking University People's HospitalN/A

See all hydrochlorothiazide; telmisartan clinical trials

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
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
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; TELMISARTAN
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS HCT TABLET;ORAL hydrochlorothiazide; telmisartan 021162 2008-12-31

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
Alembic Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010-003 Feb 25, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 209028-002 Nov 6, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Zydus Pharms TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-001 Aug 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-003 Dec 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>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 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   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-003 Apr 19, 2004   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-002 Nov 17, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for hydrochlorothiazide; telmisartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 99C0009 Belgium   Start Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0502314 SPC/GB02/037 United Kingdom   Start Trial 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
0502314 C300095 Netherlands   Start Trial PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0443983 C00443983/03 Switzerland   Start Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785 CA 2011 00026 Denmark   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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