MICARDIS Drug Patent Profile
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When do Micardis patents expire, and what generic alternatives are available?
Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs.
The generic ingredient in MICARDIS 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 MICARDIS
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 71 |
Patent Applications: | 4,727 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MICARDIS |
Drug Sales Revenues: | Drug sales revenues for MICARDIS |
What excipients (inactive ingredients) are in MICARDIS? | MICARDIS excipients list |
DailyMed Link: | MICARDIS at DailyMed |
Recent Clinical Trials for MICARDIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Hawaii | Phase 2 |
Queens Medical Center | Phase 2 |
HK inno.N Corporation | Phase 1 |
Pharmacology for MICARDIS
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for MICARDIS
Paragraph IV (Patent) Challenges for MICARDIS
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MICARDIS | Tablets | telmisartan | 20 mg, 40 mg and 80 mg | 020850 | 1 | 2006-12-26 |
US Patents and Regulatory Information for MICARDIS
Expired US Patents for MICARDIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for MICARDIS
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Micardis | telmisartan | EMEA/H/C/000209 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage. |
Authorised | no | no | no | 1998-12-16 | |
Krka, d.d., Novo mesto | Tolura | telmisartan | EMEA/H/C/001196 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage. |
Authorised | yes | no | no | 2010-06-04 | |
Teva B.V. | Telmisartan Teva Pharma | telmisartan | EMEA/H/C/002511 Treatment of essential hypertension in adults. |
Authorised | yes | no | no | 2011-10-03 | |
Teva B.V. | Telmisartan Teva | telmisartan | EMEA/H/C/001146 Treatment of essential hypertension in adults |
Withdrawn | yes | no | no | 2010-01-25 | |
Actavis Group PTC ehf | Telmisartan Actavis | telmisartan | EMEA/H/C/001168 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage. |
Authorised | yes | no | no | 2010-09-29 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for MICARDIS
See the table below for patents covering MICARDIS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1776954 | ⤷ Try a Trial | |
European Patent Office | 0581166 | ⤷ Try a Trial | |
Slovakia | 279409 | ⤷ Try a Trial | |
Australia | 765081 | ⤷ Try a Trial | |
Japan | 2709225 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MICARDIS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | 99C0014 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211 |
0502314 | C990007 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211 |
0502314 | 23/1999 | Austria | ⤷ Try a Trial | 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 | CA 2002 00023 | Denmark | ⤷ Try a Trial | |
0502314 | C300478 | Netherlands | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |