OLUMIANT Drug Patent Profile

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

See drug prices for OLUMIANT

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for OLUMIANT

NDA:

207924

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

See all OLUMIANT clinical trials

Pharmacology for OLUMIANT

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OLUMIANT

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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.

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

FDA Regulatory Exclusivity protecting OLUMIANT

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

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

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

Brazil

Canada

China

European Patent Office

Mexico

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
World Intellectual Property Organization (WIPO)	2013082476
South Korea	20120108042	AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS
Morocco	32219	مشتقات أزيتيديني سيكلوبوتان تعمل كمثبطات jak
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)

Supplementary Protection Certificates for OLUMIANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	33/2017	Austria		PRODUCT NAME: BARICITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/16/1170 (MITTEILUNG) 20170215
2288610	1790035-8	Sweden		PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215
2288610	300886	Netherlands		PRODUCT NAME: BARICITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1170 20170215
2288610	2017C/025	Belgium		PRODUCT NAME: OLUMIANT - BARICITINIB; AUTHORISATION NUMBER AND DATE: EU/1/16/1170 20170215
2288610	17C0005	France		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170215