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Last Updated: February 19, 2020

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. It is available from two suppliers. 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. Two suppliers are listed 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.

Pharmacology for NDA: 209627
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 209627
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627 NDA QPharma AB 12822-0313 12822-0313-1 1 POUCH in 1 CARTON (12822-0313-1) > 1 RING in 1 POUCH
ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627 NDA TherapeuticsMD, Inc. 50261-313 50261-313-01 1 POUCH in 1 CARTON (50261-313-01) > 1 RING in 1 POUCH

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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