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Last Updated: August 8, 2020

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INTRAROSA Drug Profile

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Which patents cover Intrarosa, and what generic alternatives are available?

Intrarosa is a drug marketed by Amag Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-three patent family members in twenty-eight countries.

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.

US ANDA Litigation and Generic Entry Outlook for Intrarosa

Intrarosa will be eligible for patent challenges on November 16, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 7, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for INTRAROSA
Drug patent expirations by year for INTRAROSA
Drug Prices for INTRAROSA

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Generic Entry Opportunity Date for INTRAROSA
Generic Entry Date for INTRAROSA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for INTRAROSA

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 INTRAROSA clinical trials

US Patents and Regulatory Information for INTRAROSA

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   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
>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:

Colorcon
Johnson and Johnson
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Boehringer Ingelheim
Moodys
Harvard Business School

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