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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Cerilliant
Baxter
Merck
Boehringer Ingelheim
Express Scripts
McKesson
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021437

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NDA 021437 describes INSPRA, which is a drug marketed by Gd Searle Llc and is included in one NDA. It is available from four suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INSPRA profile page.

The generic ingredient in INSPRA is eplerenone. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

Summary for NDA: 021437

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021437

Mechanism of ActionAldosterone Antagonists

Suppliers and Packaging for NDA: 021437

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INSPRA
eplerenone
TABLET;ORAL 021437 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1710 0025-1710-01 30 TABLET, FILM COATED in 1 BOTTLE (0025-1710-01)
INSPRA
eplerenone
TABLET;ORAL 021437 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1710 0025-1710-02 90 TABLET, FILM COATED in 1 BOTTLE (0025-1710-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 27, 2002TE:ABRLD:Yes
Patent:6,410,054*PEDPatent Expiration:Jun 8, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,410,524*PEDPatent Expiration:May 5, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,495,165*PEDPatent Expiration:Jun 8, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021437

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 20024,559,332*PED► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 20024,559,332*PED► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 20024,559,332*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Argus Health
QuintilesIMS
Cerilliant
Johnson and Johnson
Julphar
Baxter
Colorcon
Mallinckrodt

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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