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Last Updated: October 31, 2024

BARICITINIB Drug Patent Profile


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Which patents cover Baricitinib, and when can generic versions of Baricitinib launch?

Baricitinib is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA.

The generic ingredient in BARICITINIB is baricitinib. One supplier is listed for this compound. Additional details are available on the baricitinib profile page.

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Drug patent expirations by year for BARICITINIB
Recent Clinical Trials for BARICITINIB

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SponsorPhase
University of North Carolina, Chapel HillPhase 2
Healthcare PharmaceuticalsPhase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 2

See all BARICITINIB clinical trials

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
Aurobindo Pharma Ltd BARICITINIB baricitinib TABLET;ORAL 217542-001 Jul 22, 2024 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd BARICITINIB baricitinib TABLET;ORAL 217542-002 Jul 22, 2024 DISCN No 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

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

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