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Last Updated: July 6, 2020

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Prasterone - Generic Drug Details

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

Prasterone is the generic ingredient in one branded drug marketed by Amag Pharms Inc 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-three patent family members in twenty-eight countries.

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

Summary for prasterone
International Patents:53
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 7
Suppliers / Packagers: 1
Bulk Api Vendors: 83
Clinical Trials: 12
Patent Applications: 5,865
DailyMed Link:prasterone at DailyMed
Recent Clinical Trials for prasterone

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

SponsorPhase
Olivia Cardenas-Trowers, M.D.Phase 3
Center for Vulvovaginal DisordersPhase 3
AMAG Pharmaceuticals, Inc.Phase 3

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
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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:

Medtronic
Colorcon
Express Scripts
Johnson and Johnson
Mallinckrodt
AstraZeneca

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