Baricitinib - Generic Drug Details

What are the generic sources for baricitinib and what is the scope of patent protection?

Baricitinib is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baricitinib has one hundred and three patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for baricitinib

International Patents:	103
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	118
Patent Applications:	3,522
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for baricitinib
What excipients (inactive ingredients) are in baricitinib?	baricitinib excipients list
DailyMed Link:	baricitinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for baricitinib

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 baricitinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Francisco	Phase 2
Vanderbilt University	Phase 2
Vanderbilt University Medical Center	Phase 2

See all baricitinib clinical trials

Pharmacology for baricitinib

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for baricitinib

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

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BARICITINIB

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 baricitinib

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
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	No

EU/EMA Drug Approvals for baricitinib

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

International Patents for baricitinib

Country	Patent Number	Title	Estimated Expiration
Australia	2016244212	ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS
Brazil	112014013224	inibidores de jak antivirais úteis no tratamento ou prevenção de infecções retrovirais e outras infecções virais
South Korea	20180119698	탈모 질환의 치료 방법 (METHODS FOR TREATING HAIR LOSS DISORDERS)

Supplementary Protection Certificates for baricitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	CA 2017 00032	Denmark		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610	122017000045	Germany		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	315 50012-2017	Slovakia		PRODUCT NAME: BARICITINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1170 20170215