MICARDIS HCT Drug Patent Profile
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When do Micardis Hct patents expire, 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. Nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for MICARDIS HCT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 71 |
| Patent Applications: | 48 |
| 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 |
See drug prices for MICARDIS HCT
Recent Clinical Trials for MICARDIS HCT
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 HCT
| 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 MICARDIS HCT
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-002 | Nov 17, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-003 | Apr 19, 2004 | AB | RX | Yes | Yes | ⤷ 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 HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-002 | Nov 17, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-002 | Nov 17, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-001 | Nov 17, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-003 | Apr 19, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MICARDIS HCT | hydrochlorothiazide; telmisartan | TABLET;ORAL | 021162-001 | Nov 17, 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 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 | |
| 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 |
International Patents for MICARDIS HCT
See the table below for patents covering MICARDIS HCT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovakia | 32493 | BENZIMIDAZOLE DERIVATIVES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS WITH THEIR CONTENTS | ⤷ Try a Trial |
| New Zealand | 245741 | 1-BIPHENYLYLMETHYLBENZIMIDAZOLE DERIVATIVES; PHARMACEUTICAL COMPOSITIONS AND PREPARATORY METHODS | ⤷ Try a Trial |
| Taiwan | 229207 | ⤷ Try a Trial | |
| Taiwan | 239138 | ⤷ Try a Trial | |
| Singapore | 50481 | Benzimidazoles pharmaceutical compositions containing these compounds and processes for preparing them | ⤷ Try a Trial |
| Slovakia | 285429 | ⤷ Try a Trial | |
| Germany | 4117121 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MICARDIS HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0480717 | 98C0025 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215 |
| 0502314 | 1190006-5.L | Sweden | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007 |
| 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 | SPC/GB99/014 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211 |
| 0502314 | C300095 | Netherlands | ⤷ Try a Trial | PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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