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 five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and two 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: | 102 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 15 |
| Patent Applications: | 1,360 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| Yale University | Phase 2 |
| University of California, San Francisco | Phase 2 |
| Vanderbilt University | 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 five US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OLUMIANT is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Azetidine and cyclobutane derivatives as JAK inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RHEUMATOID ARTHRITIS
Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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)
Methods for treating hair loss disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA
FDA Regulatory Exclusivity protecting OLUMIANT
TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF COVID-19 IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NONINVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 207924-003 | 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 | ⤷ 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 | 207924-001 | May 31, 2018 | RX | Yes | No | ⤷ 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 | Y | Y | ⤷ 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 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. Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisBaricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.Alopecia areataBaricitinib 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: ⤷ Try a Trial
Patent: 16244212
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014013224
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 56722
Estimated Expiration: ⤷ Try a Trial
Patent: 31037
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4185420
Estimated Expiration: ⤷ Try a Trial
Patent: 7898790
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 85184
Estimated Expiration: ⤷ Try a Trial
Patent: 50544
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 14006479
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Peru | 20140099 | DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JAK | ⤷ Try a Trial |
| Croatia | P20191548 | ⤷ Try a Trial | |
| Denmark | 2288610 | ⤷ Try a Trial | |
| China | 104185420 | Antiviral jak inhibitors useful in treating or preventing retroviral and other viral infections | ⤷ Try a Trial |
| Denmark | 2830662 | ⤷ Try a Trial | |
| Lithuania | PA2017023 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLUMIANT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2288610 | 17C0005 | France | ⤷ Try a Trial | PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 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 | 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 | C02288610/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66215 19.06.2017 |
| 2288610 | PA2017023 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213 |
| 2288610 | CR 2017 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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