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Generated: November 12, 2018

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 three 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. Eleven suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 021437
Tradename:INSPRA
Applicant:Gd Searle Llc
Ingredient:eplerenone
Patents:7
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 27, 2002TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 8, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:May 5, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jun 8, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021437

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 ➤ Sign Up ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 ➤ Sign Up ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Boehringer Ingelheim
Baxter
Merck
Chinese Patent Office
Queensland Health
Mallinckrodt
Chubb

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