Generic names starting with "M"

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.


mecasermin (Injection) (Subcutaneous) Increlex
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
NDA Applicant: Ipsen Biopharmaceuticals, Inc.      BLA No.: 021839  Prod. No.: 001 Rx (40MG/4ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2012Orphan Designation: Treatment of growth hormone insensitivity syndrome.
Approved Labeled Indication: Long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.

mecasermin rinfabate (Injection) (Subcutaneous) Iplex
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
NDA Applicant: Insmed Incorporated      BLA No.: 021884  Prod. No.: 001 Disc (36MG/0.6ML (60MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2012Orphan Designation: Treatment of growth hormone insensitivity syndrome (GHIS)
Approved Labeled Indication: Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone

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

Meningococcal Group B Vaccine (Injection) (Intramuscular) Trumenba
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 125549  Prod. No.: 001 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityOct 29, 2026 

mepolizumab (For Injection) (Subcutaneous) Nucala
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == interleukin-5 antagonist
NDA Applicant: GlaxoSmithKline LLC      BLA No.: 125526  Prod. No.: 001 Rx (100MG); 002 Rx (100MG/ML); 003 Rx (100MG/ML); 004 Rx (40MG/0.4ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2024Orphan Designation: Treatment of Churg-Strauss Syndrome
Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Type: Orphan Drug ExclusivitySep 25, 2027Orphan Designation: For treatment of hypereosinophilic syndrome
Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause
Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause

mepolizumab (For Injection) (Subcutaneous) Nucala
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == interleukin-5 antagonist
NDA Applicant: GlaxoSmithKline LLC      BLA No.: 761122  Prod. No.: 001 Rx (100MG); 002 Rx (100MG/ML); 003 Rx (100MG/ML); 004 Rx (40MG/0.4ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2024Orphan Designation: Treatment of Churg-Strauss Syndrome
Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Type: Orphan Drug ExclusivitySep 25, 2027Orphan Designation: For treatment of hypereosinophilic syndrome
Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause
Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause

metreleptin (For Injection) (Subcutaneous) Myalept
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == leptin analog
NDA Applicant: Amryt Pharmaceuticals DAC      BLA No.: 125390  Prod. No.: 001 Rx (11.3MG)
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.

mogamulizumab-kpkc (Injection) (Intravenous) Poteligeo
NDA Applicant: Kyowa Kirin, Inc.      BLA No.: 761051  Prod. No.: 001 Rx (20MG/5ML (4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 8, 2025Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma.
Approved Labeled Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_zary syndrome (SS) after at least one prior systemic therapy.
Exclusivity Protected Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_zary syndrome (SS) after at least one prior systemic therapy.

moxetumomab pasudotox-tdfk (For Injection) (Intravenous) Lumoxiti
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: Innate Pharma, Inc.      BLA No.: 761104  Prod. No.: 001 Rx (1MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 13, 2025Orphan Designation: Treatment of hairy cell leukemia
Approved Labeled Indication: LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Exclusivity Protected Indication: LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).



Last edited: 15 November 2022
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