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Last Updated: May 14, 2021

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ORILISSA Drug Profile

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When do Orilissa patents expire, and what generic alternatives are available?

Orilissa is a drug marketed by Abbvie Inc and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in ORILISSA is elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Orilissa

Orilissa will be eligible for patent challenges on July 23, 2022. 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 September 10, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ORILISSA
International Patents:53
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 3
Patent Applications: 144
Drug Prices: Drug price information for ORILISSA
What excipients (inactive ingredients) are in ORILISSA?ORILISSA excipients list
DailyMed Link:ORILISSA at DailyMed
Drug patent expirations by year for ORILISSA
Drug Prices for ORILISSA

See drug prices for ORILISSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ORILISSA
Generic Entry Date for ORILISSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 ORILISSA

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

SponsorPhase
AbbViePhase 3
Wake Forest University Health SciencesPhase 2
Stanford UniversityPhase 2

See all ORILISSA clinical trials

US Patents and Regulatory Information for ORILISSA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ORILISSA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018   Get Started for $10   Get Started for $10
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018   Get Started for $10   Get Started for $10
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018   Get Started for $10   Get Started for $10
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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