Company 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.

MediWound, Ltd.
Nexobrid (For Topical Gel) (Topical) anacaulase-bcdb
NDA Applicant: MediWound, Ltd.      BLA No.: 761192  Prod. No.: 001 Disc (8.8% (1.94GM)); 002 Disc (8.8% (4.85GM))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 28, 2029Orphan Designation: Debridement of acute, deep dermal burns in hospitalized patients
Approved Labeled Indication: eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns
Exclusivity Protected Indication: eschar removal in hospitalized adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns

Merck Sharp & Dohme LLC
Ervebo (Injection) (Intramuscular) Ebola Zaire Vaccine, Live
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 125690  Prod. No.: 001 Rx (1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityDec 19, 2031 

Merck Sharp & Dohme LLC
Intron A (For Injection) (Intramuscular, Intravenous, Subcutaneous; Subcutaneous, Intravenous, Intralesional, Intramuscular; Subcutaneous, Intramuscular; Intralesional, Intramuscular, Subcutaneous) interferon alfa-2b
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 103132  Prod. No.: 001 Disc (3MIU); 002 Disc (5MIU); 003 Disc (10MIU); 004 Disc (25MIU); 005 Disc (18MIU); 006 Disc (50MIU); 007 Disc (3MIU); 008 Disc (5MIU); 009 Disc (10MIU); 010 Disc (18MIU); 011 Disc (25MIU); 012 Disc (3MIU); 013 Disc (5MIU); 014 Disc (10MIU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 21, 1995Orphan Designation: Treatment of AIDS-related Kaposi's sarcoma.
Approved Labeled Indication: Treatment of selected patients with AIDS-related Kaposi's sarcoma.

Merck Sharp & Dohme LLC
Keytruda (For Injection) (Intravenous) pembrolizumab
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 125514  Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 4, 2021Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Exclusivity Type: Orphan Drug ExclusivityDec 18, 2022Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma.
Exclusivity Protected Indication: Initial treatment of patients with unresectable or metastatic melanoma
Exclusivity Type: Orphan Drug ExclusivityMar 14, 2024Orphan Designation: Treatment of Hodgkin lymphoma.
Approved Labeled Indication: Treatment for adult and pediatric patients with refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy.
Exclusivity Protected Indication: Treatment of adult and pediatric patients with refractory classical Hodgkin Lymphoma, or who have relapsed after 3 or more prior lines of therapy.
Exclusivity Type: Orphan Drug ExclusivitySep 22, 2024Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Exclusivity Protected Indication: Treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) >or =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu targeted therapy excluding microsatellite instability-high or mismatch repair deficient gastric or gastroesophageal adenocarcinomas that have progressed and have no satisfactory alternative treatment options.
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2025Orphan Designation: Treatment of primary mediastinal B cell lymphoma.
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy
Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2025Orphan Designation: Treatment of hepatocellular carcinoma (HCC)
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Exclusivity Type: Orphan Drug ExclusivityDec 19, 2025Orphan Designation: Treatment of Merkel cell carcinoma
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma
Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma
Exclusivity Type: Orphan Drug ExclusivityFeb 15, 2026Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Exclusivity Protected Indication: KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Exclusivity Type: Orphan Drug ExclusivityJul 30, 2026Orphan Designation: Treatment of esophageal carcinoma
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS =10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Exclusivity Protected Indication: Indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] =10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Exclusivity Type: Orphan Drug ExclusivityMay 5, 2028Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma
Approved Labeled Indication: in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
Exclusivity Protected Indication: for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, excluding patients covered by Keytruda's previous indication for gastric or GEJ adenocarcinoma approved on September 22, 2017
Exclusivity Type: Orphan Drug ExclusivityDec 3, 2028Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection
Exclusivity Protected Indication: adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection, and adjuvant treatment of pediatric (12 years and older) patients with Stage III melanoma following complete resection

Merck Sharp & Dohme LLC
Vaxneuvance (Injection) (Intramuscular) Pneumococcal 15-valent Conjugate Vaccine
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 125741  Prod. No.: 001 Rx (2.0UG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJul 16, 2033 

MorphoSys US Inc.
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)

Mylan Pharmaceuticals Inc.
Semglee (Injection) (Subcutaneous) insulin glargine-yfgn
NDA Applicant: Mylan Pharmaceuticals Inc.      BLA No.: 761201  Prod. No.: 001 Rx (1,000UNITS/10ML (100UNITS/ML)); 002 Rx (300UNITS/3ML (100UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityNov 15, 2022 


Last edited: 19 August 2023
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