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Last Updated: December 8, 2024

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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 and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in twenty-six 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 was eligible for patent challenges on July 23, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2029. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ORILISSA
Drug Prices for ORILISSA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
University of North Carolina, Chapel HillPhase 2
Stanford UniversityPhase 2
Wake Forest University Health SciencesPhase 2

See all ORILISSA clinical trials

Paragraph IV (Patent) Challenges for ORILISSA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORILISSA Tablets elagolix sodium 150 mg and 200 mg 210450 9 2022-07-25

US Patents and Regulatory Information for ORILISSA

ORILISSA is protected by eleven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORILISSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN

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

Methods of treating heavy menstrual bleeding
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN TO REDUCE DYSMENORRHEA AND NON-MENSTRUAL PELVIC PAIN

Methods of treating heavy menstrual bleeding
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN HAVING DYSPAREUNIA ASSOCIATED WITH ENDOMETRIOSIS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN A PATIENT WITH MODERATE HEPATIC IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX FOR UP TO 24 MONTHS

Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

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

International Patents for ORILISSA

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2005007165 ⤷  Sign Up
Hong Kong 1051042 ⤷  Sign Up
Eurasian Patent Organization 200600190 ПРОИЗВОДНЫЕ ПИРИМИДИН-2,4-ДИОНА В КАЧЕСТВЕ АНТАГОНИСТОВ РЕЦЕПТОРА ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.