Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 21, 1995 | Orphan Designation: Treatment of AIDS related Kaposi's sarcoma. |
Hoffmann-La Roche Inc.
Zenapax (Injection) (Intravenous) daclizumab
NDA Applicant: Hoffmann-La Roche Inc. BLA No.: 103749 Prod. No.: 001 Disc (25MG/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 10, 2004 | Orphan Designation: Prevention of acute renal allograft rejection. Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. |
Horizon Therapeutics Ireland DAC
Actimmune (Injection) (Subcutaneous) interferon gamma-1b
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 103836 Prod. No.: 001 Rx (100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 20, 1997 | Orphan Designation: Treatment of chronic granulomatous disease. |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 10, 2007 | Orphan Designation: Delaying time to disease progression in patients with severe, malignant osteopetrosis. Approved Labeled Indication: Delaying time to disease progression in patients with severe, malignant osteopetrosis. |
Horizon Therapeutics Ireland DAC
Krystexxa (Injection) (Intravenous) pegloticase
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 125293 Prod. No.: 001 Rx (8MG/1ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 14, 2017 | Orphan Designation: To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective Approved Labeled Indication: Treatment of chronic gout in adult patients refractory to conventional treatment |
Horizon Therapeutics Ireland DAC
Tepezza (For Injection) (Intravenous) teprotumumab-trbw
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 761143 Prod. No.: 001 Rx (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 21, 2027 | Orphan Designation: Treatment of active thyroid eye disease Approved Labeled Indication: TEPEZZA is indicated for the treatment of Thyroid Eye Disease. Exclusivity Protected Indication: For the treatment of active Thyroid Eye Disease |
Horizon Therapeutics Ireland DAC
Uplizna (Injection) (Intravenous) inebilizumab-cdon
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 761142 Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 11, 2027 | Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders Approved Labeled Indication: Uplizna is indicated for for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Exclusivity Protected Indication: Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. |