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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.
The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. One supplier is 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 |
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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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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