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Last Updated: November 23, 2024

Details for New Drug Application (NDA): 209627


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NDA 209627 describes ANNOVERA, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug. 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
Tradename:ANNOVERA
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; segesterone acetate
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209627
Generic Entry Date for 209627*:
Constraining patent/regulatory exclusivity:
Dosage:
RING;VAGINAL

*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 TherapeuticsMD, Inc. 50261-313 50261-313-01 1 POUCH in 1 CARTON (50261-313-01) / 1 RING in 1 POUCH
ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627 NDA Mayne Pharma 68308-752 68308-752-01 1 POUCH in 1 CARTON (68308-752-01) / 30 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
Patent:⤷  Sign UpPatent Expiration:Feb 1, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
Patent:⤷  Sign UpPatent Expiration:Feb 1, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
Patent:⤷  Sign UpPatent Expiration:Feb 1, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION

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