Register entry
- Registered sites
- 0
- Active NDC listings
- 5
- Live patents
- 179
- Exclusivities
- 4
- Countries
- 0
Catalogue
Drug listings by form and route
55 active NDC listings: 5 human prescription drug. By marketing category: NDA 5.
| Dosage form | NDCs |
|---|---|
| capsule | 2 |
| tablet, film coated | 2 |
| tablet, for suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 5 |
| Labeller name on the listing | NDCs |
|---|---|
| springworks therapeutics, inc. | 5 |
Exclusivity
Patents and exclusivities
179| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7795447 | OGSIVEOnirogacestat hydrobromide | substance | Aug 2030 |
| 10590087 | OGSIVEOnirogacestat hydrobromide | substance | Aug 2039 |
| 10710966 | OGSIVEOnirogacestat hydrobromide | substance | Aug 2039 |
| 10941118 | OGSIVEOnirogacestat hydrobromide | substance | Aug 2039 |
| 11820748 | OGSIVEOnirogacestat hydrobromide | product | Aug 2039 |
| 11845732 | OGSIVEOnirogacestat hydrobromide | substance | Aug 2039 |
| 11884634 | OGSIVEOnirogacestat hydrobromide | product | Aug 2039 |
| 11884635 | OGSIVEOnirogacestat hydrobromide | product | Aug 2039 |
| 11905255 | OGSIVEOnirogacestat hydrobromide | product | Aug 2039 |
| 12116347 | OGSIVEOnirogacestat hydrobromide | product | Aug 2039 |
| 12297177 | OGSIVEOnirogacestat hydrobromide | product | Aug 2039 |
| 11066358 | GOMEKLImirdametinib | substance, product | Feb 2041 |
| 11084780 | GOMEKLImirdametinib | substance | Feb 2041 |
| 11453641 | GOMEKLImirdametinib | use | Feb 2041 |
| 11571402 | GOMEKLImirdametinib | product | Feb 2041 |
| 11806321 | GOMEKLImirdametinib | use | Feb 2041 |
| 11819487 | GOMEKLImirdametinib | use | Feb 2041 |
| 12011424 | GOMEKLImirdametinib | use | Feb 2041 |
| 12037306 | GOMEKLImirdametinib | use | Feb 2041 |
| 12090128 | GOMEKLImirdametinib | product | Feb 2041 |
| 12263146 | GOMEKLImirdametinib | use | Feb 2041 |
| 12275688 | GOMEKLImirdametinib | product | Feb 2041 |
| 12295925 | GOMEKLImirdametinib | use | Feb 2041 |
| 12357597 | GOMEKLImirdametinib | use | Feb 2041 |
| 11504354 | OGSIVEOnirogacestat hydrobromide | product | Jul 2042 |
| 11612588 | OGSIVEOnirogacestat hydrobromide | product | Jul 2042 |
| 12110277 | OGSIVEOnirogacestat hydrobromide | product | Jul 2042 |
| 12234210 | OGSIVEOnirogacestat hydrobromide | product | Jul 2042 |
| 12247012 | OGSIVEOnirogacestat hydrobromide | product | Jul 2042 |
| 12599587 | OGSIVEOnirogacestat hydrobromide | product | Jul 2042 |
| 11807611 | OGSIVEOnirogacestat hydrobromide | product | Sept 2042 |
| 11844780 | OGSIVEOnirogacestat hydrobromide | product | Sept 2042 |
| 11839595 | GOMEKLImirdametinib | use | Mar 2043 |
| 11883375 | GOMEKLImirdametinib | use | Mar 2043 |
| 12220390 | GOMEKLImirdametinib | use | Mar 2043 |
| 12257215 | GOMEKLImirdametinib | use | Mar 2043 |
| 12324791 | GOMEKLImirdametinib | use | Mar 2043 |
| 11806322 | GOMEKLImirdametinib | use | Apr 2043 |
| 11872211 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 11925619 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 11925620 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 11938116 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 11951096 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 11957662 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 12011434 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 12011435 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 12036207 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 12138246 | OGSIVEOnirogacestat hydrobromide | use | May 2043 |
| 12661330 | GOMEKLImirdametinib | use | Feb 2044 |
| 12029711 | GOMEKLImirdametinib | product | Mar 2044 |
| 12383517 | GOMEKLImirdametinib | product | Mar 2044 |
| 12390430 | GOMEKLImirdametinib | use | Oct 2044 |
| Product | Exclusivity | Until |
|---|---|---|
| GOMEKLIMIRDAMETINIB | ODE* Orphan drug | Feb 2032 |
| GOMEKLIMIRDAMETINIB | ODE-488 Orphan drug | Feb 2032 |
| OGSIVEONIROGACESTAT HYDROBROMIDE | ODE* Orphan drug | Nov 2030 |
| OGSIVEONIROGACESTAT HYDROBROMIDE | ODE-452 Orphan drug | Nov 2030 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Gomekli | mirdametinib | capsule, oral | 82448-130NDA |
| Gomekli | mirdametinib | tablet, for suspension, oral | 82448-134NDA |
| Gomekli | mirdametinib | capsule, oral | 82448-260NDA |
| OGSIVEO | nirogacestat | tablet, film coated, oral | 82448-100NDA |
| OGSIVEO | nirogacestat | tablet, film coated, oral | 82448-150NDA |
Enquiry
Common questions
- Is SpringWorks Therapeutics, Inc. FDA approved?
- SpringWorks Therapeutics, Inc. holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does SpringWorks Therapeutics, Inc. make?
- 5 products are listed under SpringWorks Therapeutics, Inc. in the openFDA NDC Directory, most often as capsule; tablet, film coated; tablet, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.