Register entry
- Registered sites
- 0
- Active NDC listings
- 1
- Live patents
- 15
- Exclusivities
- 1
- Shortage listings
- 2
- Countries
- 0
Alert
Drug shortage listings
2| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Obeticholic Acid TabletGastroenterology | Ocaliva, Tablet, 10 mg (NDC 69516-010-30) | To Be Discontinued | - | 19 Sept 202519 Sept 2025 |
| Obeticholic Acid TabletGastroenterology | Ocaliva, Tablet, 5 mg (NDC 69516-005-30) | To Be Discontinued | - | 19 Sept 202519 Sept 2025 |
Exclusivity
Patents and exclusivities
15| Patent | Product | Covers | Expiry |
|---|---|---|---|
| RE48286 | OCALIVAobeticholic acid | substance, product | Feb 2027 |
| 9040518 | LYNAVOYlinerixibat | substance, product | Sept 2031 |
| 10174073 | OCALIVAobeticholic acid | substance | Jun 2033 |
| 9238673 | OCALIVAobeticholic acid | product | Jun 2033 |
| 10047117 | OCALIVAobeticholic acid | use | Sept 2033 |
| 10052337 | OCALIVAobeticholic acid | product | Apr 2036 |
| 10751349 | OCALIVAobeticholic acid | product | Apr 2036 |
| 10758549 | OCALIVAobeticholic acid | use | Apr 2036 |
| Product | Exclusivity | Until |
|---|---|---|
| LYNAVOYLINERIXIBAT | ODE-517 Orphan drug | Mar 2033 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Lynavoy | Linerixibat | tablet, film coated, oral | 69516-140NDA |
Compare
Other companies listing linerixibat
- Glaxo Operations UK Ltd0 sites · 31 NDC
Enquiry
Common questions
- Is Intercept Pharmaceuticals Inc FDA approved?
- Intercept Pharmaceuticals Inc holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Intercept Pharmaceuticals Inc make?
- 1 product is listed under Intercept Pharmaceuticals Inc in the openFDA NDC Directory, most often as tablet, film coated. 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.