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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. Eleven 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 list11
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: hydrochlorothiazide; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL204169-003Nov 2, 2015RXNo► subscribe► subscribe
Lupin Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091351-002Aug 7, 2014RXNo► subscribe► subscribe
Lupin Ltd
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091351-001Aug 7, 2014RXNo► 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
Hungary0105148► subscribe
Portugal1144386► subscribe
Brazil0007584► 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
C0030France► subscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
C0025Belgium► subscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
2011 00026Denmark► subscribePRODUCT 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
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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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