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Last Updated: July 15, 2024

Details for New Drug Application (NDA): 210450


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NDA 210450 describes ORILISSA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ORILISSA profile page.

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 210450
Tradename:ORILISSA
Applicant:Abbvie
Ingredient:elagolix sodium
Patents:10
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210450
Generic Entry Date for 210450*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 210450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORILISSA elagolix sodium TABLET;ORAL 210450 NDA AbbVie Inc. 0074-0038 0074-0038-07 1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK
ORILISSA elagolix sodium TABLET;ORAL 210450 NDA AbbVie Inc. 0074-0038 0074-0038-28 4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jul 23, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 1, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN
Patent:⤷  Sign UpPatent Expiration:Sep 1, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE
Patent:⤷  Sign UpPatent Expiration:Jul 23, 2039Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 210450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-002 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 210450-001 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

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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.