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Generated: July 21, 2017

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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 freedom to operate?

Hydrochlorothiazide; telmisartan
is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Mylan Pharms Inc, Lupin Ltd, Boehringer Ingelheim, Macleods Pharms Ltd, and Torrent Pharms Ltd, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrochlorothiazide; telmisartan has forty-four 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 Generic Name: hydrochlorothiazide; telmisartan

Tradenames:2
Patents:2
Applicants:7
NDAs:7
Drug Master File Entries: see list31
Suppliers / Packagers: see list12
Bulk Api Vendors: see list6
Clinical Trials: see list483
Patent Applications: see list12
Drug Prices:see low prices
DailyMed Link:hydrochlorothiazide; telmisartan at DailyMed

Pharmacology for Ingredient: 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;ORAL203010-002Feb 25, 2014ABRXNoNo► Subscribe► Subscribe
Macleods Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL204169-003Nov 2, 2015ABRXNoNo► Subscribe► Subscribe
Lupin Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091351-003Aug 7, 2014ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091648-002Feb 25, 2014ABRXNoNo► Subscribe► Subscribe
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-001Nov 17, 2000ABRXYesNo6,358,986► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-001Nov 17, 20005,591,762► Subscribe
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 20045,591,762► Subscribe
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 20005,591,762► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: hydrochlorothiazide; telmisartan

Country Document Number Estimated Expiration
New Zealand513528► Subscribe
European Patent Office1144386► Subscribe
Peru13622000► Subscribe
Bulgaria105654► Subscribe
Japan4700813► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: HYDROCHLOROTHIAZIDE; TELMISARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/037United Kingdom► SubscribePRODUCT 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
C0030France► SubscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Harvard Business School
Cantor Fitzgerald
Baxter
Johnson and Johnson
Citi
Express Scripts
McKesson
Fuji
Novartis

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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