TELMISARTAN AND HYDROCHLOROTHIAZIDE Drug Patent Profile
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When do Telmisartan And Hydrochlorothiazide patents expire, and when can generic versions of Telmisartan And Hydrochlorothiazide launch?
Telmisartan And Hydrochlorothiazide is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Torrent, and Zydus Pharms. and is included in nine NDAs.
The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for TELMISARTAN AND HYDROCHLOROTHIAZIDE
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 9 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 47 |
Patent Applications: | 51 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in TELMISARTAN AND HYDROCHLOROTHIAZIDE? | TELMISARTAN AND HYDROCHLOROTHIAZIDE excipients list |
DailyMed Link: | TELMISARTAN AND HYDROCHLOROTHIAZIDE at DailyMed |
Recent Clinical Trials for TELMISARTAN AND HYDROCHLOROTHIAZIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
IlDong Pharmaceutical Co Ltd | Phase 1 |
IlDong Pharmaceutical Co Ltd | Phase 3 |
Peking University People's Hospital | N/A |
Pharmacology for TELMISARTAN AND HYDROCHLOROTHIAZIDE
Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for TELMISARTAN AND HYDROCHLOROTHIAZIDE
US Patents and Regulatory Information for TELMISARTAN AND HYDROCHLOROTHIAZIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alembic | TELMISARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; telmisartan | TABLET;ORAL | 203010-001 | Feb 25, 2014 | 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 | ||||
Torrent | TELMISARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; telmisartan | TABLET;ORAL | 201192-003 | Feb 25, 2014 | DISCN | 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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TELMISARTAN AND HYDROCHLOROTHIAZIDE
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 |