.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021532

« 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 seven suppliers. There are two patents 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. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for NDA: 021532

Tradename:
BENICAR HCT
Applicant:
Daiichi Sankyo
Ingredient:
hydrochlorothiazide; olmesartan medoxomil
Patents:2
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 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-256 35356-256-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-256-30)
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL 021532 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-257 35356-257-30 30 TABLET, FILM COATED in 1 BOTTLE (35356-257-30)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Jun 5, 2003TE:ABRLD:No
Patent:5,616,599*PEDPatent Expiration:Oct 25, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,878,703*PEDPatent Expiration:May 19, 2022Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:No
Patent:5,616,599*PEDPatent Expiration:Oct 25, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021532

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 20035,616,599*PED► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 20035,616,599*PED► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 20035,616,599*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc