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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Summary for BARICITINIB
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 123 |
| Patent Applications: | 961 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BARICITINIB |
| DailyMed Link: | BARICITINIB at DailyMed |
Recent Clinical Trials for BARICITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 2 |
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 2 |
| Healthcare Pharmaceuticals | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for BARICITINIB
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 |
