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Generated: July 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209627

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NDA 209627 describes ANNOVERA, which is a drug marketed by Therapeuticsmd Inc and is included in one NDA. Additional details are available on the ANNOVERA profile page.

The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.
Summary for 209627
Applicant:Therapeuticsmd Inc
Ingredient:ethinyl estradiol; segesterone acetate
Generic Entry Opportunity Date for 209627
Generic Entry Date for 209627*:
Constraining patent/regulatory exclusivity:

*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:RXDosage:RING;VAGINALStrength0.013MG/24HR;0.15MG/24HR
Approval Date:Aug 10, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 10, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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