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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Questions you can ask:
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Summary for ORILISSA
International Patents: | 101 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 5 |
Patent Applications: | 145 |
Drug Prices: | Drug price information for ORILISSA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ORILISSA |
What excipients (inactive ingredients) are in ORILISSA? | ORILISSA excipients list |
DailyMed Link: | ORILISSA at DailyMed |
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
Sponsor | Phase |
---|---|
University of North Carolina, Chapel Hill | Phase 2 |
Stanford University | Phase 2 |
Wake Forest University Health Sciences | Phase 2 |
Pharmacology for ORILISSA
Drug Class | Gonadotropin Releasing Hormone Receptor Antagonist |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors |
Physiological Effect | Decreased GnRH Secretion |
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 |