micardis Drug Patent Profile
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When do Micardis patents expire, and when can generic versions of Micardis launch?
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
| 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 | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-001 | Nov 17, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | AB | RX | Yes | 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 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 | 020850-003 | Apr 4, 2000 | ⤷ 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 | |
| >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 |
|---|---|---|---|
| Canada | 2352436 | POLYMORPHES DE TELMISARTANE, PROCEDES PERMETTANT DE LES PREPARER ET LEUR UTILISAITON POUR PREPARER UN MEDICAMENT (POLYMORPHS OF TELMISARTAN, PROCESSES FOR PREPARING THEM AND THEIR USE IN THE PREPARATION OF A PHARMACEUTICAL COMPOSITION) | ⤷ Try a Trial |
| Poland | 349425 | ⤷ Try a Trial | |
| Singapore | 43083 | Benzinidaziles pharmaceutical compositions containing these compounds and processes for preparing them | ⤷ 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 | SPC/GB11/010 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK |
| 0502314 | SPC/GB02/037 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 0502314 | 3/2011 | Austria | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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