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Last Updated: March 19, 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, Mylan, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TELMISARTAN
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
The George Institute for Global Health, ChinaN/A

See all HYDROCHLOROTHIAZIDE; TELMISARTAN clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; TELMISARTAN
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 204221-001 Aug 15, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 202544-001 Mar 4, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-003 Dec 15, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 091648-003 Feb 25, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 208727-002 Dec 15, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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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