OLUMIANT Drug Patent Profile
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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 four patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-seven 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.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 30, 2032. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for OLUMIANT
International Patents: | 67 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 12 |
Patent Applications: | 1,463 |
Drug Prices: | Drug price information for OLUMIANT |
What excipients (inactive ingredients) are in OLUMIANT? | OLUMIANT excipients list |
DailyMed Link: | OLUMIANT at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for OLUMIANT
Generic Entry Date for OLUMIANT*:
Constraining patent/regulatory exclusivity:
NDA:
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 OLUMIANT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Washington | Phase 2 |
Tongji Hospital | Phase 4 |
Holy Cross Hospital, Florida | Phase 1/Phase 2 |
Pharmacology for OLUMIANT
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OLUMIANT
Paragraph IV (Patent) Challenges for OLUMIANT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OLUMIANT | Tablets | baricitinib | 1 mg and 2 mg | 207924 | 2 | 2022-05-31 |
US Patents and Regulatory Information for OLUMIANT
OLUMIANT is protected by four US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OLUMIANT is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting OLUMIANT
Antiviral JAK inhibitors useful in treating or preventing coronaviridae infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NON-INVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Azetidine and cyclobutane derivatives as JAK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Azetidine and cyclobutane derivatives as JAK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RHEUMATOID ARTHRITIS
Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NON-INVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
FDA Regulatory Exclusivity protecting OLUMIANT
TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF COVID-19 IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NONINVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Exclusivity Expiration: See Plans and Pricing
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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 arthritis, Baricitinib 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. Olumiant may be used as monotherapy or in combination with methotrexate., , Atopic Dermatitis, Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy., , Alopecia areata, Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1)., |
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
Estimated Expiration: See Plans and Pricing
Patent: 16244212
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2014013224
Estimated Expiration: See Plans and Pricing
Canada
Patent: 56722
Estimated Expiration: See Plans and Pricing
Patent: 31037
Estimated Expiration: See Plans and Pricing
China
Patent: 4185420
Estimated Expiration: See Plans and Pricing
Patent: 7898790
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 85184
Estimated Expiration: See Plans and Pricing
Patent: 50544
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 14006479
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Hungary | E029767 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 2013082476 | See Plans and Pricing | |
South Korea | 20120108042 | AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS | See Plans and Pricing |
Morocco | 32219 | مشتقات أزيتيديني سيكلوبوتان تعمل كمثبطات jak | See Plans and Pricing |
Canada | 2856722 | 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) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLUMIANT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2288610 | 33/2017 | Austria | See Plans and Pricing | PRODUCT NAME: BARICITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/16/1170 (MITTEILUNG) 20170215 |
2288610 | 1790035-8 | Sweden | See Plans and Pricing | PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215 |
2288610 | 300886 | Netherlands | See Plans and Pricing | PRODUCT NAME: BARICITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1170 20170215 |
2288610 | 2017C/025 | Belgium | See Plans and Pricing | PRODUCT NAME: OLUMIANT - BARICITINIB; AUTHORISATION NUMBER AND DATE: EU/1/16/1170 20170215 |
2288610 | 17C0005 | France | See Plans and Pricing | PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170215 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |