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Generated: November 19, 2018

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Details for New Drug Application (NDA): 207924

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NDA 207924 describes OLUMIANT, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the OLUMIANT profile page.

The generic ingredient in OLUMIANT is baricitinib. One supplier is listed for this compound. Additional details are available on the baricitinib profile page.
Summary for 207924
Tradename:OLUMIANT
Applicant:Eli Lilly And Co
Ingredient:baricitinib
Patents:2
Generic Entry Opportunity Date for 207924
Generic Entry Date for 207924*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 207924
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLUMIANT baricitinib TABLET;ORAL 207924 NDA Eli Lilly and Company 0002-4182 0002-4182-30 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-30)
OLUMIANT baricitinib TABLET;ORAL 207924 NDA Eli Lilly and Company 0002-4182 0002-4182-61 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:May 31, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 31, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Jun 8, 2030Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RHEUMATOID ARTHRITIS

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