Details for Patent: 12,257,215
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Which drugs does patent 12,257,215 protect, and when does it expire?
Patent 12,257,215 protects GOMEKLI and is included in two NDAs.
This patent has forty-eight patent family members in twelve countries.
Summary for Patent: 12,257,215
| Title: | Mirdametinib treatment |
| Abstract: | The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC0-tau less than 400 ng·h/mL, (ii) a Cmax no more than 40 ng/mL, or (iii) both. |
| Inventor(s): | Uchenna H. Iloeje, Abraham J. Langseth, Todd Webster SHEARER |
| Assignee: | SpringWorks Therapeutics Inc |
| Application Number: | US18/674,168 |
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Patent Claim Types: see list of patent claims | Use; |
Drugs Protected by US Patent 12,257,215
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Springworks | GOMEKLI | mirdametinib | CAPSULE;ORAL | 219389-001 | Feb 11, 2025 | RX | Yes | No | 12,257,215 | ⤷ Start Trial | 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 | ⤷ Start Trial | ||||
| Springworks | GOMEKLI | mirdametinib | CAPSULE;ORAL | 219389-002 | Feb 11, 2025 | RX | Yes | Yes | 12,257,215 | ⤷ Start Trial | 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 | ⤷ Start Trial | ||||
| Springworks | GOMEKLI | mirdametinib | TABLET, FOR SUSPENSION;ORAL | 219379-001 | Feb 11, 2025 | RX | Yes | Yes | 12,257,215 | ⤷ Start Trial | 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 | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 12,257,215
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2023233745 | ⤷ Start Trial | |||
| Australia | 2023234587 | ⤷ Start Trial | |||
| Australia | 2023234590 | ⤷ Start Trial | |||
| Australia | 2023236367 | ⤷ Start Trial | |||
| Canada | 3254258 | ⤷ Start Trial | |||
| Canada | 3254428 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
