OLUMIANT Drug Patent Profile
✉ Email this page to a colleague
When do Olumiant patents expire, and when can generic versions of Olumiant launch?
Olumiant is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and three patent family members in forty-four countries.
The generic ingredient in OLUMIANT is baricitinib. One supplier is listed for this compound. Additional details are available on the baricitinib profile page.
DrugPatentWatch® Generic Entry Outlook for Olumiant
Olumiant was eligible for patent challenges on May 31, 2022.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for OLUMIANT?
- What are the global sales for OLUMIANT?
- What is Average Wholesale Price for OLUMIANT?
Summary for OLUMIANT
International Patents: | 103 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 16 |
Patent Applications: | 2,443 |
Drug Prices: | Drug price information for OLUMIANT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OLUMIANT |
What excipients (inactive ingredients) are in OLUMIANT? | OLUMIANT excipients list |
DailyMed Link: | OLUMIANT at DailyMed |


Recent Clinical Trials for OLUMIANT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of North Carolina, Chapel Hill | Phase 2 |
Yale University | Phase 2 |
University of California, San Francisco | Phase 2 |
Pharmacology for OLUMIANT
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Paragraph IV (Patent) Challenges for OLUMIANT
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 OLUMIANT
OLUMIANT is protected by six US patents and two FDA Regulatory Exclusivities.
EU/EMA Drug Approvals for OLUMIANT
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 OLUMIANT
When does loss-of-exclusivity occur for OLUMIANT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 12345732
Patent: Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections
Estimated Expiration: ⤷ Try for Free
Patent: 16244212
Patent: ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2014013224
Patent: inibidores de jak antivirais úteis no tratamento ou prevenção de infecções retrovirais e outras infecções virais
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 56722
Patent: INHIBITEURS DE JAK ANTIVIRAUX UTILES DANS LE TRAITEMENT OU LA PREVENTION D'INFECTIONS RETROVIRALES ET AUTRES INFECTIONS VIRALES (ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 31037
Patent: INHIBITEURS DE JAK ANTIVIRAUX UTILES DANS LE TRAITEMENT OU LA PREVENTION D'INFECTIONS RETROVIRALES ET AUTRES INFECTIONS VIRALES (ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS)
Estimated Expiration: ⤷ Try for Free
China
Patent: 4185420
Patent: Antiviral jak inhibitors useful in treating or preventing retroviral and other viral infections
Estimated Expiration: ⤷ Try for Free
Patent: 7898790
Patent: 用于治疗或预防逆转录病毒和其它病毒感染的抗病毒JAK抑制剂 (Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections)
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 85184
Patent: COMPOSITIONS CONTENANT DES INHIBITEURS DE JAK ET DES MÉDICAMENTS HAART DESTINÉES À LA PRÉVENTION OU AU TRAITEMENT DU VIH (COMPOSITIONS COMPRISING JAK INHIBITORS AND HAART DRUGS FOR USE IN THE PREVENTION OR TREATMENT OF HIV)
Estimated Expiration: ⤷ Try for Free
Patent: 50544
Patent: INHIBITEURS JAK DESTINÉES À LA PRÉVENTION OU AU TRAITEMENT DES INFECTIONS VIRALES (JAK INHIBITORS FOR USE IN THE PREVENTION OR TREATMENT OF VIRAL INFECTION)
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 14006479
Patent: INHIBIDORES ANTIVIRALES DE LA JANUS CINASA UTILES EN EL TRATAMIENTO O PREVENCION DE INFECCIONES RETROVIRALES Y OTRAS INFECCIONES VIRALES. (ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS.)
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering OLUMIANT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 2288610 | ⤷ Try for Free | |
Denmark | 2288610 | ⤷ Try for Free | |
Serbia | 55263 | DERIVATI AZETIDINA I CIKLOBUTANA KAO JAK INHIBITORI (AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS) | ⤷ Try for Free |
Poland | 2830662 | ⤷ Try for Free | |
New Zealand | 587928 | AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS | ⤷ Try for Free |
Australia | 2016244212 | ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS | ⤷ Try for Free |
Spain | 2602577 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLUMIANT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2288610 | CA 2017 00032 | Denmark | ⤷ Try for Free | PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215 |
2288610 | C02288610/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66215 19.06.2017 |
2288610 | 300886 | Netherlands | ⤷ Try for Free | PRODUCT NAME: BARICITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1170 20170215 |
2288610 | CR 2017 00032 | Denmark | ⤷ Try for Free | PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215 |
2288610 | 2017/032 | Ireland | ⤷ Try for Free | PRODUCT NAME: BARACITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/16/1170 20170213 |
2288610 | 33/2017 | Austria | ⤷ Try for Free | PRODUCT NAME: BARICITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/16/1170 (MITTEILUNG) 20170215 |
2288610 | C20170022 00232 | Estonia | ⤷ Try for Free | PRODUCT NAME: BARITSITINIIB;REG NO/DATE: EU/1/16/1170 15.02.2017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for OLUMIANT
More… ↓