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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 four 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-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for NDA: 020850

Tradename:
MICARDIS
Applicant:
Boehringer Ingelheim
Ingredient:
telmisartan
Patents:3
Therapeutic Class:Cardiovascular Agents
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 Roxane Laboratories, Inc. 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 Roxane Laboratories, Inc. 0054-0543 0054-0543-18 3 BLISTER PACK in 1 CARTON (0054-0543-18) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 10, 1998TE:ABRLD:No
Patent:6,358,986Patent Expiration:Jan 10, 2020Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 10, 1998TE:ABRLD:Yes
Patent:6,358,986Patent Expiration:Jan 10, 2020Product Flag?Substance Flag?Delist Request?
Patent:7,998,953Patent Expiration:Jun 6, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION

Expired Orange Book Patents for NDA: 020850

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-003Apr 4, 20005,591,762► subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-002Nov 10, 19985,591,762► subscribe
Boehringer Ingelheim
MICARDIS
telmisartan
TABLET;ORAL020850-001Nov 10, 19985,591,762► subscribe
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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 verifification 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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