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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021633


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NDA 021633 describes FEMTRACE, which is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug. Additional details are available on the FEMTRACE profile page.

The generic ingredient in FEMTRACE is estradiol acetate. 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 acetate profile page.
Summary for 021633
Tradename:FEMTRACE
Applicant:Apil
Ingredient:estradiol acetate
Patents:1
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021633
Generic Entry Date for 021633*:
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;ORALStrength0.45MG
Approval Date:Aug 20, 2004TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 2, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.9MG
Approval Date:Aug 20, 2004TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 2, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.8MG
Approval Date:Aug 20, 2004TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 2, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 021633

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 ⤷  Try a Trial ⤷  Try a Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 ⤷  Try a Trial ⤷  Try a Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 ⤷  Try a Trial ⤷  Try a Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 ⤷  Try a Trial ⤷  Try a Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 ⤷  Try a Trial ⤷  Try a Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.