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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021532

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NDA 021532 describes BENICAR HCT, which is a drug marketed by Daiichi Sankyo and is included in one NDA. It is available from six suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the BENICAR HCT profile page.

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-one drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for 021532

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021532

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 021532

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532 NDA A-S Medication Solutions 50090-1083 50090-1083-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1083-0)
BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532 NDA Physicians Total Care, Inc. 54868-5075 54868-5075-1 90 TABLET, FILM COATED in 1 BOTTLE (54868-5075-1)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Oct 25, 2016Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Oct 25, 2016Product Flag?Substance Flag?Delist Request?

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Oct 25, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021532

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-002Jun 5, 2003► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-005Jun 5, 2003► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-003Jun 5, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Citi
Baxter
Healthtrust
Farmers Insurance
US Department of Justice
Express Scripts
Moodys
Chubb

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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