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Last Updated: January 30, 2023

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-seven patent family members in thirty-one countries.

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

Summary for prasterone
International Patents:57
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 7
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 92
Clinical Trials: 17
Patent Applications: 6,805
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
AMAG Pharmaceuticals, Inc.Phase 2
University of ArkansasPhase 2

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

EU/EMA Drug Approvals for prasterone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Endoceutics S.A. Intrarosa prasterone EMEA/H/C/004138
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,
Authorised no no no 2018-01-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for prasterone

Country Patent Number Title Estimated Expiration
Denmark 2185157 See Plans and Pricing
European Patent Office 2441456 Compositions de DHEA pour traiter la ménopause (DHEA compositions for treating menopose) See Plans and Pricing
China 102861335 DHEA compositions for treating menopause See Plans and Pricing
Japan 2013060475 DHEA COMPOSITION FOR TREATING MENOPAUSE See Plans and Pricing
Japan 6197292 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Merck

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.