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: Ref. Product Exclusivity | Aug 29, 2024 |
UCB, Inc.
Rystiggo (Injection) (Subcutaneous) rozanolixizumab-noli
NDA Applicant: UCB, Inc. BLA No.: 761286 Prod. No.: 001 Rx (280MG/2ML (140MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 26, 2030 | Orphan Designation: Treatment of myasthenia gravis Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive |
Ultragenyx Pharamceutical Inc.
Mepsevii (Injection) (Intravenous) vestronidase alfa-vjbk
NDA Applicant: Ultragenyx Pharamceutical Inc. BLA No.: 761047 Prod. No.: 001 Rx (10MG/5ML (2MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 15, 2024 | Orphan Designation: Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome) Approved Labeled Indication: Indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (PMS VII, Sly syndrome). Exclusivity Protected Indication: Indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome). |
United Therapeutics Corporation
Unituxin (Injection) (Intravenous) dinutuximab
NDA Applicant: United Therapeutics Corporation BLA No.: 125516 Prod. No.: 001 Rx (17.5MG/5ML (3.5MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 10, 2022 | Orphan Designation: Treatment of neuroblastoma Approved Labeled Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy Exclusivity Protected Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy |