BARICITINIB - Generic Drug Details

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

Baricitinib is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd and Eli Lilly And Co, and is included in two NDAs. 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:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	123
Patent Applications:	1,957
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

Recent Clinical Trials for BARICITINIB

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 2
Healthcare Pharmaceuticals	Phase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	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

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Glossary

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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	207924-001	May 31, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 BARICITINIB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for BARICITINIB

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Country	Patent Number	Title	Estimated Expiration
Ecuador	SP10010475	DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JAK	⤷ Sign Up
Spain	2602577		⤷ Sign Up
Cyprus	2017024		⤷ Sign Up
Slovenia	2288610		⤷ Sign Up
South Korea	102027394		⤷ Sign Up
Japan	2015515470	脱毛障害を処置するための方法	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BARICITINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	2017033	Norway	⤷ Sign Up	PRODUCT NAME: BARICITINIB OG FARMASOEYTISK; REG. NO/DATE: EU/1/16/1170 20170222
2288610	33/2017	Austria	⤷ Sign Up	PRODUCT NAME: BARICITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/16/1170 (MITTEILUNG) 20170215
2288610	SPC/GB17/045	United Kingdom	⤷ Sign Up	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	CR 2017 00032	Denmark	⤷ Sign Up	PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610	132017000078559	Italy	⤷ Sign Up	PRODUCT NAME: BARICITINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(OLUMIANT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1170, 20170215
2288610	PA2017023,C2288610	Lithuania	⤷ Sign Up	PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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