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.
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Ref. Product Exclusivity | Dec 16, 2034 |
natalizumab (Injection) (Intravenous) Tysabri
NDA Applicant: Biogen Inc. BLA No.: 125104 Prod. No.: 001 Rx (300MG/15ML (20MG/ML))
Patents | Expiration | Patented 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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Nov 25, 2027 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Nov 24, 2022 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 22, 2021 | Orphan 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 Exclusivity | May 17, 2023 | Orphan 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 Exclusivity | Apr 25, 2024 | Orphan 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 Exclusivity | Dec 20, 2024 | Orphan 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 Exclusivity | Jun 10, 2027 | Orphan 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 Exclusivity | Apr 16, 2028 | Orphan 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 Exclusivity | Apr 16, 2028 | Orphan 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 Exclusivity | May 20, 2028 | Orphan 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 Exclusivity | May 20, 2028 | Orphan 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 Exclusivity | May 27, 2029 | Orphan 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 Exclusivity | May 27, 2029 | Orphan 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 Exclusivity | Feb 15, 2030 | Orphan 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 Exclusivity | Feb 15, 2030 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2029 | Orphan 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 |