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Last Updated: October 21, 2021

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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 patent protection?

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

SponsorPhase
Lee's Pharmaceutical LimitedPhase 3
Dr. Santiago PalaciosPhase 3
Hospital Clinic of BarcelonaPhase 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Millicent INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Millicent INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Millicent INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Merck
Johnson and Johnson
Mallinckrodt
McKesson

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