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Last Updated: March 28, 2024

Baricitinib - Generic Drug Details


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What are the generic sources for baricitinib and what is the scope of patent protection?

Baricitinib is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baricitinib has one hundred and two patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for baricitinib
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for baricitinib
Generic Entry Date for baricitinib*:
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.

Recent Clinical Trials for baricitinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yale UniversityPhase 2
University of California, San FranciscoPhase 2
Vanderbilt UniversityPhase 2

See all baricitinib clinical trials

Pharmacology for baricitinib
Drug ClassJanus Kinase Inhibitor
Mechanism of ActionJanus Kinase Inhibitors
Paragraph IV (Patent) Challenges for BARICITINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OLUMIANT Tablets baricitinib 4 mg 207924 1 2023-10-03
OLUMIANT Tablets baricitinib 1 mg and 2 mg 207924 2 2022-05-31

US Patents and Regulatory Information for baricitinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-003 May 10, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-003 May 10, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-002 Oct 8, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-003 May 10, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-002 Oct 8, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-002 Oct 8, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-002 Oct 8, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for baricitinib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eli Lilly Nederland B.V. Olumiant baricitinib EMEA/H/C/004085
Rheumatoid arthritisBaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisOlumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.Alopecia areataBaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).Juvenile idiopathic arthritisBaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:- Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),- Enthesitis related arthritis, and- Juvenile psoriatic arthritis.Baricitinib may be used as monotherapy or in combination with methotrexate.
Authorised no no no 2017-02-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for baricitinib

Country Patent Number Title Estimated Expiration
Japan 5275371 ⤷  Try a Trial
European Patent Office 3459565 PROCÉDÉS DE TRAITEMENT DE TROUBLES DE PERTE DE CHEVEUX (METHODS FOR TREATING HAIR LOSS DISORDERS) ⤷  Try a Trial
Ecuador SP10010475 DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JAK ⤷  Try a Trial
Japan 2013155179 AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITOR ⤷  Try a Trial
Dominican Republic P2010000270 DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JAK ⤷  Try a Trial
Poland 2830662 ⤷  Try a Trial
Portugal 2288610 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for baricitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2288610 1790035-8 Sweden ⤷  Try a Trial PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215
2288610 CA 2017 00032 Denmark ⤷  Try a Trial PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610 PA2017023 Lithuania ⤷  Try a Trial PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610 122017000045 Germany ⤷  Try a Trial PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610 SPC/GB17/045 United Kingdom ⤷  Try a Trial PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/16/1170/001(NI) 20170215; UK EU/1/16/1170/002(NI) 20170215; UK EU/1/16/1170/003(NI) 20170215; UK EU/1/16/1170/004(NI) 20170215; UK EU/1/16/1170/005(NI) 20170215; UK EU/1/16/1170/006(NI) 20170215; UK EU/1/16/1170/013(NI) 20170215; UK EU/1/16/1170/014(NI) 20170215; UK EU/1/16/1170/015(NI) 20170215; UK EU/1/16/1170/016(NI) 20170215; UK PLGB 14895/0255 20170215; UK PLGB 14895/0256 20170215; UK EU/1/16/1170/007(NI) 20170215; UK EU/1/16/1170/008(NI) 20170215; UK EU/1/16/1170/009(NI) 20170215; UK EU/1/16/1170/010(NI) 20170215; UK EU/1/16/1170/011(NI) 20170215; UK EU/1/16/1170/012(NI) 20170215
2288610 LUC00027 Luxembourg ⤷  Try a Trial PRODUCT NAME: BARICITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/16/1170 20170215
2288610 C20170022 00232 Estonia ⤷  Try a Trial PRODUCT NAME: BARITSITINIIB;REG NO/DATE: EU/1/16/1170 15.02.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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