MICARDIS HCT Drug Patent Profile
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Which patents cover Micardis Hct, and when can generic versions of Micardis Hct launch?
Micardis Hct is a drug marketed by Boehringer Ingelheim and is included in one NDA.
The generic ingredient in MICARDIS HCT is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
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Questions you can ask:
- What is the 5 year forecast for MICARDIS HCT?
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- What is Average Wholesale Price for MICARDIS HCT?
Summary for MICARDIS HCT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 72 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MICARDIS HCT |
What excipients (inactive ingredients) are in MICARDIS HCT? | MICARDIS HCT excipients list |
DailyMed Link: | MICARDIS HCT at DailyMed |
Recent Clinical Trials for MICARDIS HCT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tyler J Curiel | Early Phase 1 |
University of Hawaii | Phase 2 |
Queens Medical Center | Phase 2 |
Pharmacology for MICARDIS HCT
Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Paragraph IV (Patent) Challenges for MICARDIS HCT
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 MICARDIS HCT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-001 | Nov 17, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-002 | Nov 17, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-003 | Apr 19, 2004 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for MICARDIS HCT
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 | 021162-001 | Nov 17, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for MICARDIS HCT
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for MICARDIS HCT
See the table below for patents covering MICARDIS HCT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 245741 | 1-BIPHENYLYLMETHYLBENZIMIDAZOLE DERIVATIVES; PHARMACEUTICAL COMPOSITIONS AND PREPARATORY METHODS | ⤷ Sign Up |
Finland | 920486 | ⤷ Sign Up | |
Poland | 211829 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MICARDIS HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | 23/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 19981211 |
0502314 | C300478 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
0565634 | 06C0030 | France | ⤷ Sign Up | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |