Register entry
Actelion Pharmaceuticals US, Inc.
Data as of · How to read this entry
- Registered sites
- 0
- Active NDC listings
- 21
- Live patents
- 146
- Exclusivities
- 3
- Countries
- 0
Catalogue
Drug listings by form and route
2121 active NDC listings: 21 human prescription drug. By marketing category: NDA 21.
| Dosage form | NDCs |
|---|---|
| tablet, coated | 8 |
| tablet, film coated | 7 |
| injection, powder, lyophilized, for solution | 2 |
| capsule | 1 |
| injection, powder, for solution | 1 |
| kit | 1 |
| tablet, for suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 17 |
| intravenous | 3 |
| Labeller name on the listing | NDCs |
|---|---|
| actelion pharmaceuticals us, inc. | 21 |
Exclusivity
Patents and exclusivities
146| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7205302 | UPTRAVIselexipag | substance, product | Oct 2026 |
| 8598227 | VELETRIepoprostenol sodium | use | Feb 2027 |
| 10946015*PED | OPSUMIT, OPSYNVImacitentan; macitentan; tadalafil | use | Mar 2027 |
| 8318802 | VELETRIepoprostenol sodium | product | Mar 2027 |
| 7205302*PED | UPTRAVIselexipag | use | Apr 2027 |
| 9265762 | OPSUMITmacitentan | product | May 2027 |
| 9265762*PED | OPSUMITmacitentan | use | Nov 2027 |
| 7959945 | TRACLEERbosentan | product | Dec 2027 |
| 8367685 | OPSUMITmacitentan | product | Oct 2028 |
| 8367685*PED | OPSUMITmacitentan | use | Apr 2029 |
| 8268847 | OPSUMIT, OPSYNVImacitentan; macitentan; tadalafil | product | Apr 2029 |
| 9173881 | UPTRAVIselexipag | use | Aug 2029 |
| 8268847*PED | OPSUMIT, OPSYNVImacitentan; macitentan; tadalafil | use | Oct 2029 |
| 9173881*PED | UPTRAVIselexipag | use | Feb 2030 |
| 9284280 | UPTRAVIselexipag | use | Jun 2030 |
| 8791122 | UPTRAVIselexipag | substance, product | Aug 2030 |
| 9284280*PED | UPTRAVIselexipag | use | Dec 2030 |
| 8791122*PED | UPTRAVIselexipag | use | Feb 2031 |
| 10821108 | UPTRAVIselexipag | product | Dec 2036 |
| 10828298 | UPTRAVIselexipag | product | Dec 2036 |
| 10821108*PED | UPTRAVIselexipag | use | Jun 2037 |
| 10828298*PED | UPTRAVIselexipag | use | Jun 2037 |
| Product | Exclusivity | Until |
|---|---|---|
| OPSUMITMACITENTAN | PED Paediatric | Aug 2028 |
| OPSYNVIMACITENTAN; TADALAFIL | PED Paediatric | Sept 2031 |
| UPTRAVISELEXIPAG | PED Paediatric | Nov 2029 |
Catalogue
Marketed products
21| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| OPSUMIT | macitentan | tablet, film coated, oral | 66215-501NDA |
| OPSYNVI | macitentan and tadalafil | tablet, film coated, oral | 66215-812NDA |
| OPSYNVI | macitentan and tadalafil | tablet, film coated, oral | 66215-814NDA |
| Tracleer | bosentan | tablet, film coated, oral | 66215-101NDA |
| Tracleer | bosentan | tablet, film coated, oral | 66215-102NDA |
| Tracleer | bosentan | tablet, for suspension, oral | 66215-232NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-602NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-604NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-606NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-608NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-610NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-612NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-614NDA |
| UPTRAVI | Selexipag | tablet, coated, oral | 66215-616NDA |
| UPTRAVI | Selexipag | injection, powder, for solution, intravenous | 66215-718NDA |
| UPTRAVI | Selexipag | tablet, film coated, oral | 66215-910NDA |
| UPTRAVI | Selexipag | tablet, film coated, oral | 66215-915NDA |
| UPTRAVI Titration Pack | Selexipag | kit | 66215-628NDA |
| Veletri | epoprostenol | injection, powder, lyophilized, for solution, intravenous | 66215-402NDA |
| Veletri | epoprostenol | injection, powder, lyophilized, for solution, intravenous | 66215-403NDA |
| Zavesca | miglustat | capsule, oral | 66215-201NDA |
Compare
Other companies listing selexipag
- Zydus Lifesciences Limited12 sites · 717 NDC
- MSN Laboratories Private Limited,8 sites · 275 NDC
- Zydus Pharmaceuticals USA Inc.1 site · 626 NDC
- NURAY CHEMICALS PRIVATE LIMITED1 site · 105 NDC
- Maithri Drugs Private Limited1 site · 80 NDC
- Excella GmbH & Co. KG1 site · 73 NDC
- Teva Czech Industries s.r.o.1 site · 41 NDC
Enquiry
Common questions
- Is Actelion Pharmaceuticals US, Inc. FDA approved?
- Actelion Pharmaceuticals US, Inc. holds no registered establishment of its own; 21 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Actelion Pharmaceuticals US, Inc. make?
- 21 products are listed under Actelion Pharmaceuticals US, Inc. in the openFDA NDC Directory, most often as tablet, coated; tablet, film coated; injection, powder, lyophilized, for 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.