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OLUMIANT Drug 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 two patents protecting this drug.

This drug has fifty-four patent family members in forty-two countries.

The generic ingredient in OLUMIANT is baricitinib. One supplier is listed for this compound. Additional details are available on the baricitinib profile page.

US ANDA Litigation and Generic Entry Outlook for Olumiant

Olumiant will be eligible for patent challenges on May 31, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 8, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OLUMIANT

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	84
Clinical Trials:	1
Patent Applications:	42
Drug Prices:	Drug price information for OLUMIANT
DailyMed Link:	OLUMIANT at DailyMed

See drug prices for OLUMIANT

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
Washington University School of Medicine	Phase 1

See all OLUMIANT clinical trials

Pharmacology for OLUMIANT

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Synonyms for OLUMIANT

(1-(Ethylsulfonyl)-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl)ethanenitrile

{1-(ethylsulfonyl)-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]azetidin-3-yl}acetonitrile

1-(Ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-3-azetidineacetonitrile

1187594-09-7

2-(3-(4-(3H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile

2-(3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile

2-[1-ETHYLSULFONYL-3-[4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)PYRAZOL-1-YL]AZETIDIN-3-YL]ACETONITRILE

3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)-

3-AZETIDINEACETONITRILE, 1-(ETHYLSULFONYL)-3-[4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL]-

3JW

AB0035958

ABP001023

AC-27404

AJ-121247

AK143352

AKOS022186127

AKOS025401933

AM81232

AMMD00005

AOB87724

AX8261519

Baricitinib

Baricitinib (INCB28050 LY3009104)

Baricitinib (JAN/USAN/INN)

Baricitinib (LY3009104, INCB028050)

Baricitinib (LY3009104)

Baricitinib [USAN:INN]

baricitinib-ly3009104

BC600315

BCP04686

BCP0726000031

BCP9000380

BDBM50021656

C16H17N7O2S

CHEBI:95341

CHEMBL2105759

CS-0724

D10308

DB11817

DS-7641

DTXSID30152228

EX-A413

GTPL7792

HMS3651L17

HY-15315

INCB 028050

INCB 28050

INCB-028050

INCB-028050|||LY-3009104|||2-[1-Ethylsulfonyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]azetidin-3-yl]acetonitrile

INCB028050

ISP4442I3Y

J-503551

KS-0000044L

LY 3009104

LY-3009104

LY3009104

MFCD21608464

MLS006011247

NCGC00345839-01

NCGC00345839-14

Olumiant (TN)

PB27275

QCR-197

RL00725

S-7686

s2851

SB10845

SC-94301

SCHEMBL871150

SMR004703006

SW220096-1

UNII-ISP4442I3Y

XUZMWHLSFXCVMG-UHFFFAOYSA-N

Y0439

ZINC73069247

US Patents and Regulatory Information for 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
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	Yes
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	Yes
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	Yes			Y	Y

International Patents for OLUMIANT

Country	Patent Number	Estimated Expiration
Croatia	P20161390
Luxembourg	C00027
Costa Rica	11640
Eurasian Patent Organization	201071057
South Korea	20100121657
Hong Kong	1149005
World Intellectual Property Organization (WIPO)	2009114512

Supplementary Protection Certificates for OLUMIANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	2017033	Norway		PRODUCT NAME: BARICITINIB OG FARMASOEYTISK; REG. NO/DATE: EU/1/16/1170 20170222
2288610	CA 2017 00032	Denmark		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610	17C0005	France		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170215
2288610	C02288610/01	Switzerland		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66215 19.06.2017
2288610	PA2017023	Lithuania		PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	1790035-8	Sweden		PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215
2288610	LUC00027	Luxembourg		PRODUCT NAME: BARICITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/16/1170 20170215