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OLUMIANT Drug Patent Profile

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When do Olumiant patents expire, and what generic alternatives are available?

Olumiant is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and three 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.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for OLUMIANT

International Patents:	103
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	16
Patent Applications:	961
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

Drug patent expirations by year for OLUMIANT

Recent Clinical Trials for OLUMIANT

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 2
Yale University	Phase 2
University of California, San Francisco	Phase 2

See all OLUMIANT clinical trials

Pharmacology for OLUMIANT

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for OLUMIANT

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 OLUMIANT

OLUMIANT is protected by six US patents and two FDA Regulatory Exclusivities.

Patents protecting OLUMIANT

Antiviral JAK inhibitors useful in treating or preventing coronaviridae infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA

Azetidine and cyclobutane derivatives as JAK inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Azetidine and cyclobutane derivatives as JAK inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF RHEUMATOID ARTHRITIS

Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections
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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
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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: ⤷ Sign Up

TREATMENT OF COVID-19 IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NONINVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Exclusivity Expiration: ⤷ Sign Up

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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	207924-002	Oct 8, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022		RX	Yes	Yes	⤷ 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	207924-002	Oct 8, 2019		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 OLUMIANT

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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 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
Patent: Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections
Estimated Expiration: ⤷ Sign Up

Patent: 16244212
Patent: ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2014013224
Patent: inibidores de jak antivirais úteis no tratamento ou prevenção de infecções retrovirais e outras infecções virais
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 56722
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Patent: 31037
Patent: 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)
Estimated Expiration: ⤷ Sign Up

China

Patent: 4185420
Patent: Antiviral jak inhibitors useful in treating or preventing retroviral and other viral infections
Estimated Expiration: ⤷ Sign Up

Patent: 7898790
Patent: 用于治疗或预防逆转录病毒和其它病毒感染的抗病毒JAK抑制剂 (Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 85184
Patent: COMPOSITIONS CONTENANT DES INHIBITEURS DE JAK ET DES MÉDICAMENTS HAART DESTINÉES À LA PRÉVENTION OU AU TRAITEMENT DU VIH (COMPOSITIONS COMPRISING JAK INHIBITORS AND HAART DRUGS FOR USE IN THE PREVENTION OR TREATMENT OF HIV)
Estimated Expiration: ⤷ Sign Up

Patent: 50544
Patent: INHIBITEURS JAK DESTINÉES À LA PRÉVENTION OU AU TRAITEMENT DES INFECTIONS VIRALES (JAK INHIBITORS FOR USE IN THE PREVENTION OR TREATMENT OF VIRAL INFECTION)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 14006479
Patent: INHIBIDORES ANTIVIRALES DE LA JANUS CINASA UTILES EN EL TRATAMIENTO O PREVENCION DE INFECCIONES RETROVIRALES Y OTRAS INFECCIONES VIRALES. (ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS.)
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Lithuania	2288610		⤷ Sign Up
Slovenia	2635299		⤷ Sign Up
Eurasian Patent Organization	017218	ПРОИЗВОДНЫЕ АЗЕТИДИНА И ЦИКЛОБУТАНА КАК ИНГИБИТОРЫ JAK-КИНАЗ (AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS)	⤷ Sign Up
Slovenia	2830662		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OLUMIANT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	33/2017	Austria	⤷ Sign Up	PRODUCT NAME: BARICITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/16/1170 (MITTEILUNG) 20170215
2288610	1790035-8	Sweden	⤷ Sign Up	PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215
2288610	PA2017023	Lithuania	⤷ Sign Up	PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description