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Last Updated: August 13, 2022

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

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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
Drug patent expirations by year for OLUMIANT
Drug Prices for OLUMIANT

See drug prices for OLUMIANT

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

SponsorPhase
University of WashingtonPhase 2
Tongji HospitalPhase 4
Holy Cross Hospital, FloridaPhase 1/Phase 2

See all OLUMIANT clinical trials

Pharmacology 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

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-003 May 10, 2022 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-002 Oct 8, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-002 Oct 8, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924-001 May 31, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 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

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Boehringer Ingelheim
Baxter
AstraZeneca
McKinsey

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