Tradenames starting with "M"

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

Menquadfi (Injection) (Intramuscular) Meningococcal (Groups A, C, Y, W) Conjugate Vaccine
NDA Applicant: Sanofi Pasteur Inc.      BLA No.: 125701  Prod. No.: 001 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJan 14, 2017 

Mepsevii (Injection) (Intravenous) vestronidase alfa-vjbk
NDA Applicant: Ultragenyx Pharamceutical Inc.      BLA No.: 761047  Prod. No.: 001 Rx (10MG/5ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 15, 2024Orphan 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).

Monjuvi (For Injection) (Intravenous) tafasitamab-cxix
NDA Applicant: MorphoSys US Inc.      BLA No.: 761163  Prod. No.: 001 Rx (200MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 31, 2027Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: MONJUVI is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)
Exclusivity Protected Indication: indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)

Mononine (For Injection) (Intravenous) Coagulation Factor IX (Human)
NDA Applicant: CSL Behring LLC      BLA No.: 103957  Prod. No.: 001 Disc (1000IU); 002 Disc (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 20, 1999Orphan Designation: Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B.
Approved Labeled Indication: Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.

Myalept (For Injection) (Subcutaneous) metreleptin
NDA Applicant: Amryt Pharmaceuticals DAC      BLA No.: 125390  Prod. No.: 001 Rx (11.3MG)
PatentsExpirationPatented Use
Pat. No. 11555176 Cell culture medium for eukaryotic cells
Claim Types: Process
Pat. Sub. Date(s): None		Jan 27, 2040 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 24, 2021Orphan Designation: Treatment of metabolic disorders secondary to lipodystrophy
Approved Labeled Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
Exclusivity Protected Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Mylotarg (For Injection) (Intravenous) gemtuzumab ozogamicin
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 761060  Prod. No.: 001 Rx (4.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2007Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
Exclusivity Type: Orphan Drug ExclusivitySep 1, 2024Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity Protected Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity Type: Orphan Drug ExclusivityJun 16, 2027Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Mylotarg is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older.
Exclusivity Protected Indication: For the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in pediatric patients 1 month and older

Myobloc (Injection) (Intramuscular, Intraglandular) rimabotulinumtoxinB
NDA Applicant: Solstice NeuroSciences, LLC      BLA No.: 103846  Prod. No.: 001 Rx (2,500UNITS/0.5ML); 002 Rx (5,000UNITS/ML); 003 Rx (10,000UNITS/2ML (5,000UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2007Orphan Designation: Treatment of cervical dystonia.
Approved Labeled Indication: Treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Myozyme (For Injection) (Intravenous) alglucosidase alfa
NDA Applicant: Genzyme Corporation      BLA No.: 125141  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 28, 2013Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.


Last edited: 19 August 2023
© 2001-2023 Bruce A. Pokras, All rights reserved worldwide