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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020850

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NDA 020850 describes MICARDIS, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from two suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the MICARDIS profile page.

The generic ingredient in MICARDIS is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 020850
Tradename:MICARDIS
Applicant:Boehringer Ingelheim
Ingredient:telmisartan
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 020850
Suppliers and Packaging for NDA: 020850
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICARDIS telmisartan TABLET;ORAL 020850 NDA AUTHORIZED GENERIC West-Ward Pharmaceuticals Corp. 0054-0542 0054-0542-18 3 BLISTER PACK in 1 CARTON (0054-0542-18) > 10 TABLET in 1 BLISTER PACK
MICARDIS telmisartan TABLET;ORAL 020850 NDA AUTHORIZED GENERIC West-Ward Pharmaceuticals Corp. 0054-0543 0054-0543-18 3 BLISTER PACK in 1 CARTON (0054-0543-18) > 10 TABLET in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 020850
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS TABLET;ORAL telmisartan 020850 2006-12-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 10, 1998TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 10, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 10, 1998TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 10, 2020Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 6, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION

Expired US Patents for NDA 020850

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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