You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
AstraZeneca
Express Scripts
Moodys
Johnson and Johnson

Last Updated: April 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021532


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021532 describes BENICAR HCT, which is a drug marketed by Daiichi Sankyo and is included in one NDA. It is available from four suppliers. Additional details are available on the BENICAR HCT profile page.

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 021532
Tradename:BENICAR HCT
Applicant:Daiichi Sankyo
Ingredient:hydrochlorothiazide; olmesartan medoxomil
Patents:0
Pharmacology for NDA: 021532
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 50090-4329 50090-4329-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-4329-0)
BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532 NDA A-S Medication Solutions 50090-4329 50090-4329-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-4329-1)
Paragraph IV (Patent) Challenges for 021532
Tradename Dosage Ingredient NDA Submissiondate
BENICAR HCT TABLET;ORAL hydrochlorothiazide; olmesartan medoxomil 021532 2007-05-11
BENICAR HCT TABLET;ORAL hydrochlorothiazide; olmesartan medoxomil 021532 2007-02-15

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021532

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-005 Jun 5, 2003   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-002 Jun 5, 2003   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-003 Jun 5, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Express Scripts
Dow
Moodys
McKesson

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.