Generic names starting with "N"

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.


nadofaragene firadenovec-vncg (For Suspension) (Intravesical) Adstiladrin
NDA Applicant: Ferring Pharmaceuticals A/S      BLA No.: 125700  Prod. No.: 001 Disc (3x10^11 viral particles (vp)/mL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityDec 16, 2034 

natalizumab (Injection) (Intravenous) Tysabri
NDA Applicant: Biogen Inc.      BLA No.: 125104  Prod. No.: 001 Rx (300MG/15ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 7157276 Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2024 
Pat. No. 7759117 Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2024 
Pat. No. 8124350 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Aug 2, 2027 
Pat. No. 8318416 Nutrient monitoring and feedback control for increased bioproduct production
Claim Types: Process
Pat. Sub. Date(s): None
Jan 20, 2031 
Pat. No. 8809049 Methods for producing mammalian cells
Claim Types: Process
Pat. Sub. Date(s): None
May 22, 2031 
Pat. No. 8871449 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Apr 12, 2026 
Pat. No. 9005926 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
Oct 1, 2030 
Pat. No. 9096879 Method of supplementing culture media to prevent undesirable amino acid substitutions
Claim Types: Process
Pat. Sub. Date(s): None
Jan 7, 2031 
Pat. No. 9109015 Method of isolating biomacromolecules using low pH and divalent cations
Claim Types: Process
Pat. Sub. Date(s): None
Aug 13, 2031 
Pat. No. 9212379 Nutrient monitoring and feedback control for increased bioproduct production
Claim Types: Process
Pat. Sub. Date(s): None
Nov 28, 2030 
Pat. No. 9316641 Assay for JC virus antibodies
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Jan 9, 2032 
Pat. No. 9493567 Methods of treating inflammatory and autoimmune diseases with natalizumab
Claim Types: Method of use
Pat. Sub. Date(s): None
Mar 5, 2027 
Pat. No. 9562252 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
May 11, 2033 
Pat. No. 9696307 Methods for the detection of JC polyoma virus
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Feb 5, 2030 
Pat. No. 9709575 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Apr 4, 2026 
Pat. No. 9790533 Methods of preventing and removing trisulfide bonds
Claim Types: Cell culture
Pat. Sub. Date(s): None
May 11, 2032 
Pat. No. 9994968 Electrochemical etching apparatus
Claim Types: Process
Pat. Sub. Date(s): None
Aug 19, 2034 
Pat. No. 10023831 Gas delivery devices and associated systems and methods
Claim Types: Device
Pat. Sub. Date(s): None
Mar 17, 2035 
Pat. No. 10119976 Method of assessing risk of PML
Claim Types: Diagnostic or surgical method; Method of use
Pat. Sub. Date(s): None
May 27, 2034 
Pat. No. 10233245 Methods of treating inflammatory and autoimmune diseases with natalizumab
Claim Types: Method of use
Pat. Sub. Date(s): None
Feb 28, 2027 
Pat. No. 10308706 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
Feb 5, 2031 
Pat. No. 10444234 Assay for JC virus antibodies
Claim Types: Diagnostic or surgical method; Device
Pat. Sub. Date(s): None
Jan 11, 2031 
Pat. No. 10590454 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
May 11, 2032 
Pat. No. 10676772 Control of protein glycosylation by culture medium supplementation and cell culture process parameters
Claim Types: Process
Pat. Sub. Date(s): None
Aug 19, 2034 
Pat. No. 10677803 Method of assessing risk of PML
Claim Types: Method of use
Pat. Sub. Date(s): None
May 27, 2034 
Pat. No. 10705095 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Apr 4, 2026 
Pat. No. 10844416 Manganese supplementation for control of glycosylation in mammalian cell culture process
Claim Types: Process
Pat. Sub. Date(s): None
Jun 1, 2036 
Pat. No. 11124760 Methods for overcoming glutamine deprivation during mammalian cell culture
Claim Types: Process
Pat. Sub. Date(s): None
Aug 27, 2035 
Pat. No. 11268119 Copper supplementation for control of glycosylation in mammalian cell culture process
Claim Types: Process
Pat. Sub. Date(s): None
Feb 21, 2036 
Pat. No. 11280794 Method of assessing risk of PML
Claim Types: Method of use
Pat. Sub. Date(s): None
May 27, 2034 
Pat. No. 11287423 Assay for JC virus antibodies
Claim Types: Formulation; Process
Pat. Sub. Date(s): None
Jan 11, 2031 
Pat. No. 11292845 Methods of treating inflammatory and autoimmune diseases with natalizumab
Claim Types: Method of use
Pat. Sub. Date(s): None
Feb 28, 2027 

naxitamab-gqgk (Injection) (Intravenous) Danyelza
NDA Applicant: Y-mABs Therapeutics, Inc      BLA No.: 761171  Prod. No.: 001 Rx (40MG/10ML (4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 25, 2027Orphan Designation: Treatment of neuroblastoma
Approved Labeled Indication: in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy
Exclusivity Protected Indication: treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy

necitumumab (Injection) (Intravenous) Portrazza
NDA Applicant: Eli Lilly and Company      BLA No.: 125547  Prod. No.: 001 Rx (800MG/50ML (16MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 24, 2022Orphan Designation: Treatment of squamous non-small cell lung cancer
Approved Labeled Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer.
Exclusivity Protected Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. PORTRAZZA is not indicated for treatment of non-squamous, non-small cell lung cancer

nivolumab (Injection) (Intravenous) Opdivo
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125554  Prod. No.: 001 Rx (40MG/4ML (10MG/ML)); 002 Rx (100MG/10ML (10MG/ML)); 003 Rx (240MG/24ML (10MG/ML)); 004 Rx (120MG/12ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 22, 2021Orphan Designation: Treatment of Stage IIb to IV 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 Protected 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 ExclusivityMay 17, 2023Orphan Designation: Treatment of Hodgkin lymphoma
Approved Labeled Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
Exclusivity Protected Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
Exclusivity Type: Orphan Drug ExclusivityApr 25, 2024Orphan Designation: Treatment of Hodgkin lymphoma
Approved Labeled Indication: Treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or 3 or more lines of systemic therapy that includes autologous HSCT.
Exclusivity Protected Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after 3 or more lines of systemic therapy that includes autologous HSCT, not including any overlap with the orphan exclusivity awarded for the 2016 marketing approval of nivolumab for the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin.
Exclusivity Type: Orphan Drug ExclusivityDec 20, 2024Orphan Designation: Treatment of Stage IIb to IV melanoma
Approved Labeled Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity Protected Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity Type: Orphan Drug ExclusivityJun 10, 2027Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: Opdivo (nivolumab) indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Exclusivity Protected Indication: For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Exclusivity Type: Orphan Drug ExclusivityApr 16, 2028Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer
Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Protected Indication: treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Type: Orphan Drug ExclusivityApr 16, 2028Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Protected Indication: treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Type: Orphan Drug ExclusivityMay 20, 2028Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer
Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Protected Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Type: Orphan Drug ExclusivityMay 20, 2028Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Protected Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Type: Orphan Drug ExclusivityMay 27, 2029Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: In combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Exclusivity Protected Indication: First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Exclusivity Type: Orphan Drug ExclusivityMay 27, 2029Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Exclusivity Protected Indication: First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Exclusivity Type: Orphan Drug ExclusivityFeb 15, 2030Orphan Designation: Treatment of Stage IIb to IV melanoma
Approved Labeled Indication: As a single agent or in combination with ipilimumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma
Exclusivity Protected Indication: Treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma
Exclusivity Type: Orphan Drug ExclusivityFeb 15, 2030Orphan Designation: Treatment of Stage IIb to IV melanoma
Approved Labeled Indication: adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity Protected Indication: adjuvant treatment of pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

nivolumab and relatlimab-rmbw (Injection) (Intravenous) Opdualag
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 761234  Prod. No.: 001 Rx (240MG, 80MG/20ML (12MG, 4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2029Orphan Designation: Treatment of stage IIb to IV melanoma
Approved Labeled Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma
Exclusivity Protected Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma



Last edited: 19 August 2023
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