Details for New Drug Application (NDA): 208470
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NDA 208470 describes INTRAROSA, which is a drug marketed by Millicent and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the INTRAROSA profile page.
The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.
The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.
Summary for 208470
| Tradename: | INTRAROSA |
| Applicant: | Millicent |
| Ingredient: | prasterone |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208470
Generic Entry Date for 208470*:
Constraining patent/regulatory exclusivity:
Dosage:
INSERT;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.
Suppliers and Packaging for NDA: 208470
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INTRAROSA | prasterone | INSERT;VAGINAL | 208470 | NDA | Millicent US, Inc. | 72495-401 | 72495-401-28 | 1 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK |
| INTRAROSA | prasterone | INSERT;VAGINAL | 208470 | NDA | Millicent US, Inc. | 72495-501 | 72495-501-14 | 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INSERT;VAGINAL | Strength | 6.5MG | ||||
| Approval Date: | Nov 16, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 8,268,806 | Patent Expiration: | Mar 19, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,629,129 | Patent Expiration: | Aug 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,957,054 | Patent Expiration: | Jan 8, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INTRAVAGINAL PRASTERONE (DEHYDROEPIANDROSTERONE) AT A DAILY DOSE OF 6.5MG FOR THE TREATMENT OF DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE | ||||||||
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