Details for New Drug Application (NDA): 211280
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NDA 211280 describes REYVOW, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the REYVOW profile page.
The generic ingredient in REYVOW is lasmiditan succinate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lasmiditan succinate profile page.
The generic ingredient in REYVOW is lasmiditan succinate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lasmiditan succinate profile page.
Summary for 211280
| Tradename: | REYVOW |
| Applicant: | Eli Lilly And Co |
| Ingredient: | lasmiditan succinate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211280
Generic Entry Date for 211280*:
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: 211280
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REYVOW | lasmiditan succinate | TABLET;ORAL | 211280 | NDA | Eli Lilly and Company | 0002-4312 | 0002-4312-08 | 2 BLISTER PACK in 1 CARTON (0002-4312-08) / 4 TABLET in 1 BLISTER PACK |
| REYVOW | lasmiditan succinate | TABLET;ORAL | 211280 | NDA | Eli Lilly and Company | 0002-4491 | 0002-4491-08 | 2 BLISTER PACK in 1 CARTON (0002-4491-08) / 4 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jan 31, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 11,053,214 | Patent Expiration: | Dec 5, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | ACUTE TREATMENT OF MIGRAINE | ||||||||
| Patent: | 12,071,423 | Patent Expiration: | Jul 6, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,257,246 | Patent Expiration: | Jul 7, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS | ||||||||
Expired US Patents for NDA 211280
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | REYVOW | lasmiditan succinate | TABLET;ORAL | 211280-001 | Jan 31, 2020 | 8,748,459 | ⤷ Start Trial |
| Eli Lilly And Co | REYVOW | lasmiditan succinate | TABLET;ORAL | 211280-003 | Dec 18, 2020 | 8,748,459 | ⤷ Start Trial |
| Eli Lilly And Co | REYVOW | lasmiditan succinate | TABLET;ORAL | 211280-002 | Jan 31, 2020 | 8,748,459 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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