Details for New Drug Application (NDA): 219379
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NDA 219379 describes GOMEKLI, which is a drug marketed by Springworks and is included in two NDAs. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the GOMEKLI profile page.
The generic ingredient in GOMEKLI is mirdametinib. One supplier is listed for this compound. Additional details are available on the mirdametinib profile page.
The generic ingredient in GOMEKLI is mirdametinib. One supplier is listed for this compound. Additional details are available on the mirdametinib profile page.
Summary for 219379
| Tradename: | GOMEKLI |
| Applicant: | Springworks |
| Ingredient: | mirdametinib |
| Patents: | 20 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219379
Generic Entry Date for 219379*:
Constraining patent/regulatory exclusivity:
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 Dosage:
TABLET, FOR SUSPENSION;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: 219379
Suppliers and Packaging for NDA: 219379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GOMEKLI | mirdametinib | TABLET, FOR SUSPENSION;ORAL | 219379 | NDA | SpringWorks Therapeutics, Inc. | 82448-134 | 82448-134-42 | 42 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-42) |
| GOMEKLI | mirdametinib | TABLET, FOR SUSPENSION;ORAL | 219379 | NDA | SpringWorks Therapeutics, Inc. | 82448-134 | 82448-134-84 | 84 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-84) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;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: | 11,066,358 | Patent Expiration: | Feb 17, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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