Register entry
- Registered sites
- 0
- Active NDC listings
- 5
- Labeller names
- 2
- Live patents
- 20
- Exclusivities
- 2
- Countries
- 0
Catalogue
Drug listings by form and route
55 active NDC listings: 5 human prescription drug. By marketing category: NDA 3, BLA 2.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 3 |
| injection, solution | 2 |
| Route | NDCs |
|---|---|
| oral | 3 |
| intravenous | 2 |
| intramuscular | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| servier pharmaceuticals llc | 4 |
| servier pharmaceutical llc | 1 |
Exclusivity
Patents and exclusivities
20| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10610125 | TIBSOVOivosidenib | use | Jun 2030 |
| 10717764 | TIBSOVOivosidenib | use | Jan 2033 |
| 11667673 | TIBSOVOivosidenib | use | Jan 2033 |
| 9850277 | TIBSOVOivosidenib | substance, product | Jan 2033 |
| 9474779 | TIBSOVOivosidenib | substance, product | Aug 2033 |
| 10172864 | VORANIGOvorasidenib | substance, product | Jul 2034 |
| 12433895 | VORANIGOvorasidenib | use | Jul 2034 |
| 9579324 | VORANIGOvorasidenib | substance | Jul 2034 |
| 10449184 | TIBSOVOivosidenib | product | Mar 2035 |
| 10799490 | TIBSOVOivosidenib | product | Mar 2035 |
| 9968595 | TIBSOVOivosidenib | product | Mar 2035 |
| 11844758 | VORANIGOvorasidenib | use | Dec 2035 |
| 10653710 | TIBSOVOivosidenib | use | Oct 2036 |
| 11345677 | VORANIGOvorasidenib | substance, product | Jan 2039 |
| 10980788 | TIBSOVOivosidenib | use | Jun 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| TIBSOVOIVOSIDENIB | ODE-447 Orphan drug | Oct 2030 |
| VORANIGOVORASIDENIB | ODE-491 Orphan drug | Aug 2031 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ONCASPAR | Pegaspargase | injection, solution, intramuscular, intravenous | 72694-954BLA |
| TIBSOVO | ivosidenib | tablet, film coated, oral | 72694-617NDA |
| VORANIGO | vorasidenib | tablet, film coated, oral | 72694-728NDA |
| VORANIGO | vorasidenib | tablet, film coated, oral | 72694-879NDA |
| asparlas | calaspargase pegol | injection, solution, intravenous | 72694-515BLA |
Enquiry
Common questions
- Is Servier Pharmaceuticals LLC FDA approved?
- Servier Pharmaceuticals LLC 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 Servier Pharmaceuticals LLC make?
- 5 products are listed under Servier Pharmaceuticals LLC in the openFDA NDC Directory, most often as tablet, film coated; injection, solution. 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.