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 six 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.
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: | 6 |
Pharmacology for NDA: 207924
| Mechanism of Action | Janus Kinase Inhibitors |
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: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | May 31, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 13, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA | ||||||||
| Regulatory Exclusivity Expiration: | May 10, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF COVID-19 IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NONINVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) | ||||||||
| Patent: | 11,045,474 | Patent Expiration: | Nov 30, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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) | ||||||||
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