Details for New Drug Application (NDA): 219389
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NDA 219389 describes GOMEKLI, which is a drug marketed by Springworks and is included in two NDAs. It is available from one supplier. There are twenty-three patents protecting this drug. Additional details are available on the GOMEKLI profile page.
The generic ingredient in GOMEKLI is mirdametinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mirdametinib profile page.
The generic ingredient in GOMEKLI is mirdametinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mirdametinib profile page.
Summary for 219389
| Tradename: | GOMEKLI |
| Applicant: | Springworks |
| Ingredient: | mirdametinib |
| Patents: | 20 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219389
Generic Entry Date for 219389*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.
Pharmacology for NDA: 219389
Suppliers and Packaging for NDA: 219389
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GOMEKLI | mirdametinib | CAPSULE;ORAL | 219389 | NDA | SpringWorks Therapeutics, Inc. | 82448-130 | 82448-130-42 | 42 CAPSULE in 1 BOTTLE (82448-130-42) |
| GOMEKLI | mirdametinib | CAPSULE;ORAL | 219389 | NDA | SpringWorks Therapeutics, Inc. | 82448-260 | 82448-260-42 | 42 CAPSULE in 1 BOTTLE (82448-260-42) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Feb 11, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 11, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 11, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 17, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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