Details for New Drug Application (NDA): 209627
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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 Action | Estrogen 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: | RX | Dosage: | RING;VAGINAL | Strength | 0.013MG/24HR;0.15MG/24HR | ||||
Approval Date: | Aug 10, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 1, 2039 | Product 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 Up | Patent Expiration: | Feb 1, 2039 | Product 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 Up | Patent Expiration: | Feb 1, 2039 | Product 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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