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Last Updated: November 20, 2024

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, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TELMISARTAN
US Patents:0
Tradenames:2
Applicants:10
NDAs:10
Finished Product Suppliers / Packagers: 10
Raw Ingredient (Bulk) Api Vendors: 9
Clinical Trials: 47
Patent Applications: 92
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
Drug ClassAngiotensin 2 Receptor Blocker
Thiazide Diuretic
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; TELMISARTAN
C03AA Thiazides, plain
C03A LOW-CEILING DIURETICS, THIAZIDES
C03 DIURETICS
C Cardiovascular system
C03AA Thiazides, plain
C03A LOW-CEILING DIURETICS, THIAZIDES
C03 DIURETICS
C Cardiovascular system
C09CA Angiotensin II receptor blockers (ARBs), plain
C09C ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09 AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C Cardiovascular system
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; TELMISARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MICARDIS HCT Tablets hydrochlorothiazide; telmisartan 80 mg/12.5 mg and 40 mg/12.5 mg 021162 1 2008-12-31

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; TELMISARTAN

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Natco TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 091648-002 Feb 25, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-003 Aug 15, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma 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 021162-001 Nov 17, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-002 Dec 15, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204169-001 Nov 2, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-001 Aug 15, 2017 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 021162-002 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
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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EU/EMA Drug Approvals for HYDROCHLOROTHIAZIDE; TELMISARTAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Krka, d.d., Novo mesto Tolucombi telmisartan, hydrochlorothiazide EMEA/H/C/002549
Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.		 Authorised yes no no 2013-03-13
Bayer AG Kinzalkomb telmisartan, hydrochlorothiazide EMEA/H/C/000415
Treatment of essential hypertension.Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.		 Authorised no no no 2002-04-19
Bayer AG PritorPlus telmisartan, hydrochlorothiazide EMEA/H/C/000414
Treatment of essential hypertension.PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.		 Authorised no no no 2002-04-22
Actavis Group hf Actelsar HCT telmisartan, hydrochlorothiazide EMEA/H/C/002676
Treatment of essential hypertension.Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately. 		Authorised yes no no 2013-03-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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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 verification 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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