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Last Updated: October 14, 2019

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ORILISSA Drug Profile

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

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

This drug has forty-seven patent family members in twenty-three 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.

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

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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
Stanford UniversityPhase 2
University of North Carolina, Chapel HillPhase 2

See all ORILISSA clinical trials

Synonyms for ORILISSA
153E876
4-(((1R)-2-(5-(2-Fluoro-3-methoxyphenyl)-3-((2-fluoro-6-(trifluoromethyl)phenyl)methyl)-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl)-1-phenylethyl)amino)butanoic acid
4-[[(1R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-4-methyl-2,6-dioxo-pyrimidin-1-yl]-1-phenyl-ethyl]amino]butanoic acid
4-[[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-4-methyl-2,6-dioxopyrimidin-1-yl]-1-phenylethyl]amino]butanoic acid
4-{[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-1-yl]-1-phenylethyl]amino}butanoic acid
5B2546MB5Z
834153-87-6
ABT-620
AN-27202
BCP08827
Butanoic acid, 4-(((1R)-2-(5-(2-fluoro-3-methoxyphenyl)-3-((2-fluoro-6-(trifluoromethyl)phenyl)methyl)-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl)-1-phenylethyl)amino)-
CHEMBL1208155
compound 10b [PMID 19006286]
CS-5329
D09335
DB11979
DTXSID40232348
ELA gOLIX
Elagolix
Elagolix (USAN/INN)
Elagolix [USAN:INN]
EX-A1765
GTPL8362
HY-14789
NBI 56418
NBI-56418
NBI56418
SB16700
SCHEMBL1642523
UNII-5B2546MB5Z
Z-3253
ZINC49888891

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   See Pricing   See Pricing Y Y   See Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No   See Pricing   See Pricing   See Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No   See Pricing   See Pricing   See Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes   See Pricing   See Pricing   See Pricing
>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:

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