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Last Updated: January 17, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021443

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NDA 021443 describes ENJUVIA, which is a drug marketed by Aspen and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ENJUVIA profile page.

The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated synthetic b profile page.
Summary for 021443
Tradename:ENJUVIA
Applicant:Aspen
Ingredient:estrogens, conjugated synthetic b
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021443
Generic Entry Date for 021443*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.3MG
Approval Date:Dec 20, 2004TE:RLD:No
Patent:  Start TrialPatent Expiration:Mar 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
Patent:  Start TrialPatent Expiration:Mar 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Patent:  Start TrialPatent Expiration:Feb 12, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

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