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Last Updated: May 24, 2022

ORILISSA Drug Patent 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 five patents protecting this drug.

This drug has thirty-six 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:36
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 5
Patent Applications: 195
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
Wake Forest University Health SciencesPhase 2
University of North Carolina, Chapel HillPhase 2
Stanford UniversityPhase 2

See all ORILISSA clinical trials

US Patents and Regulatory Information for ORILISSA

ORILISSA is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORILISSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ORILISSA

Methods of administering elagolix
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN

Methods of administering elagolix
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE

Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS

Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS

FDA Regulatory Exclusivity protecting ORILISSA

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing 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

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 See Plans and Pricing See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 See Plans and Pricing See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ORILISSA

When does loss-of-exclusivity occur for ORILISSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04257639
Estimated Expiration: See Plans and Pricing

Austria

Patent: 7679
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0412314
Estimated Expiration: See Plans and Pricing

Canada

Patent: 31508
Estimated Expiration: See Plans and Pricing

China

Patent: 19829
Estimated Expiration: See Plans and Pricing

Patent: 0424078
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0080646
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08656
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 46389
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0370
Estimated Expiration: See Plans and Pricing

Patent: 0600190
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 46389
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004016516
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2833
Estimated Expiration: See Plans and Pricing

Japan

Patent: 22844
Estimated Expiration: See Plans and Pricing

Patent: 26760
Estimated Expiration: See Plans and Pricing

Patent: 07521309
Estimated Expiration: See Plans and Pricing

Patent: 11088902
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06000297
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4747
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4897
Estimated Expiration: See Plans and Pricing

Patent: 056251
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46389
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46389
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46389
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0600475
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1139148
Estimated Expiration: See Plans and Pricing

Patent: 060031851
Estimated Expiration: See Plans and Pricing

Spain

Patent: 14448
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORILISSA around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1108656 See Plans and Pricing
Denmark 1255738 See Plans and Pricing
European Patent Office 1646389 DERIVES DE PYRIMIDINE-2, 4-DIONE UTILISES COMME ANTAGONISTES DU RECEPTEUR D'HORMONE LIBERANT DE LA GONADOTROPHINE (PYRIMIDINE-2,4-DIONE DERIVATIVES AS GONADOTROPIN-RELEASING HORMONE RECEPTOR ANTAGONISTS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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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.