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.

Xenpozyme (For Injection) (Intravenous) olipudase alfa-rpcp
NDA Applicant: Genzyme Corporation BLA No.: 761261 Prod. No.: 001 Rx (20MG); 002 Rx (4MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 31, 2029	Orphan Designation: Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease) Approved Labeled Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients Exclusivity Protected Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients

Patents	Expiration	Patented Use
Pat. No. 7364736 Antibodies to OPGL Claim Types: Compound; Composition Pat. Sub. Date(s): None	Feb 19, 2025
Pat. No. 7427659 Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction Claim Types: Process Pat. Sub. Date(s): None	Mar 15, 2025
Pat. No. 7928205 Methods for refolding of recombinant antibodies Claim Types: Process Pat. Sub. Date(s): None	Feb 12, 2027
Pat. No. 8058418 Polynucleotides encoding heavy and light chains of antibodies to OPGL Claim Types: Formulation Pat. Sub. Date(s): None	Nov 30, 2023
Pat. No. 9012178 Dipeptides to enhance yield and viability from cell cultures Claim Types: Process; Cell culture Pat. Sub. Date(s): None	Aug 5, 2031
Pat. No. 9133493 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None	Apr 20, 2032
Pat. No. 9228168 Feed media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None	Jan 19, 2030
Pat. No. 9320816 Methods of treating cell culture media for use in a bioreactor Claim Types: Process Pat. Sub. Date(s): None	Nov 14, 2030
Pat. No. 9328134 Carbohydrate phosphonate derivatives as modulators of glycosylation Claim Types: Compound; Process Pat. Sub. Date(s): None	Feb 20, 2034
Pat. No. 9359435 Methods for modulating mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	May 22, 2027
Pat. No. 9388447 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None	Apr 20, 2032
Pat. No. 9481901 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	May 29, 2034
Pat. No. 10167492 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None	Dec 1, 2035
Pat. No. 10513723 Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	Dec 9, 2034
Pat. No. 10583397 Process control systems and methods for use with filters and filtration processes Claim Types: Device Pat. Sub. Date(s): None	Jul 28, 2035
Pat. No. 10822630 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None	Dec 1, 2035
Pat. No. 10894972 Methods for increasing mannose content of recombinant proteins Claim Types: Cell culture medium; Process Pat. Sub. Date(s): None	May 29, 2034
Pat. No. 11077404 Process control systems and methods for use with filters and filtration processes Claim Types: Device; Process Pat. Sub. Date(s): None	May 13, 2035
Pat. No. 11098079 Charged depth filtration of antigen-binding proteins Claim Types: Process Pat. Sub. Date(s): None	Jul 21, 2037
Pat. No. 11130980 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	Apr 5, 2035
Pat. No. 11254963 Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	Dec 9, 2034
Pat. No. 11299760 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	Oct 30, 2034
Pat. No. 11434514 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	May 29, 2034
Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 13, 2020	Orphan 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 Exclusivity	Dec 5, 2021	Orphan 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
NDA Applicant: Auxilium Pharmaceuticals, Inc. BLA No.: 125338 Prod. No.: 001 Rx (0.9MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Feb 2, 2017 Orphan 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 Exclusivity Dec 6, 2020 Orphan 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 2, 2017	Orphan 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 Exclusivity	Dec 6, 2020	Orphan 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.