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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Healthtrust
Colorcon
Accenture
QuintilesIMS
McKinsey
Daiichi Sankyo
Federal Trade Commission

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021040

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NDA 021040 describes PREFEST, which is a drug marketed by Teva Womens and is included in one NDA. There are two patents protecting this drug. Additional details are available on the PREFEST profile page.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norgestimate profile page.
Summary for 021040
Tradename:PREFEST
Applicant:Teva Womens
Ingredient:estradiol; norgestimate
Patents:2
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 22, 1999TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 20, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:HORMONE REPLACEMENT
Patent:➤ Sign UpPatent Expiration:Mar 30, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND VAGINAL ATROPHY; PREVENTION OF OSTEOPOROSIS

Expired US Patents for NDA 021040

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 ➤ Sign Up ➤ Sign Up
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 ➤ 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:

Medtronic
Moodys
UBS
AstraZeneca
McKesson
Federal Trade Commission
Argus Health
Farmers Insurance
Daiichi Sankyo

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