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Last Updated: April 13, 2024

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.
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:RXDosage:INSERT;VAGINALStrength6.5MG
Approval Date:Nov 16, 2016TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 19, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 7, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jan 8, 2030Product 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.