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Hydrochlorothiazide; telmisartan - Generic Drug Details

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

This ingredient has forty-two patent family members in thirty-four countries.

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

Summary for Generic Name: hydrochlorothiazide; telmisartan

Tradenames:2
Patents:1
Applicants:6
NDAs:6
Drug Master File Entries: see list31
Suppliers / Packaging: see list10
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydrochlorothiazide; telmisartan

Clinical Trials for: hydrochlorothiazide; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-001Nov 17, 2000RXNo6,358,986<disabled> <disabled>
Torrent Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL201192-002Feb 25, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091648-001Feb 25, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; telmisartan

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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<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-003Apr 19, 20045,591,762<disabled>
Boehringer Ingelheim
MICARDIS HCT
hydrochlorothiazide; telmisartan
TABLET;ORAL021162-002Nov 17, 20005,591,762<disabled>
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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<disabled in preview>
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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
China1144790<disabled in preview>
Germany50004150<disabled in preview>
Australia765081<disabled in preview>
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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
2011 00026Denmark<disabled>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/GB99/008United Kingdom<disabled>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
C0030France<disabled>PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
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