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Prasterone - Generic Drug Details

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What are the generic sources for prasterone and what is the scope of freedom to operate?

Prasterone is the generic ingredient in one branded drug marketed by Millicent and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Prasterone has fifty-six patent family members in thirty countries.

There are seven drug master file entries for prasterone. One supplier is listed for this compound.

Summary for prasterone

International Patents:	56
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	16
Patent Applications:	6,782
What excipients (inactive ingredients) are in prasterone?	prasterone excipients list
DailyMed Link:	prasterone at DailyMed

Recent Clinical Trials for prasterone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
Dr. Santiago Palacios	Phase 3
Hospital Clinic of Barcelona	Phase 4

See all prasterone clinical trials

US Patents and Regulatory Information for prasterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes

International Patents for prasterone

Country	Patent Number	Estimated Expiration
Japan	5725283
Eurasian Patent Organization	201000312
South Korea	20130103805
Ukraine	100701
Israel	203747
Japan	2013060475