Tradenames starting with "X"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Xgeva (Injection) (Subcutaneous) denosumab
Drug Classes: Metabolic Bone Disease Agents == RANK ligand (RANKL) inhibitor
NDA Applicant: Amgen, Inc.      BLA No.: 125320  Prod. No.: 003 Rx (120MG/1.7ML (70MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2020Orphan Designation: Treatment of patients with giant cell tumor of bone
Approved Labeled Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Exclusivity Protected Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Exclusivity Type: Orphan Drug ExclusivityDec 5, 2021Orphan Designation: Treatment of hypercalcemia in malignancy
Approved Labeled Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy.
Exclusivity Protected Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy.

Xiaflex (For Injection) (Intralesional) collagenase clostridium histolyticum
Drug Classes: Dermatological Agents:Dermatological Agents, Other == collagen-specific enzyme
NDA Applicant: Auxilium Pharmaceuticals, Inc.      BLA No.: 125338  Prod. No.: 001 Rx (0.9MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 2, 2017Orphan Designation: Treatment of advanced (involutional or residual stage) Dupuytren's disease
Approved Labeled Indication: Treatment of adult patients with Dupuytren's contracture with a palpable cord
Exclusivity Type: Orphan Drug ExclusivityDec 6, 2020Orphan Designation: Treatment of Peyronie's disease.
Approved Labeled Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Exclusivity Protected Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.



Last edited: 15 November 2022
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