Company names starting with "J"

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.


Janssen Biotech, Inc.
Darzalex (Injection) (Intravenous) daratumumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD38-directed cytolytic antibody
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761036  Prod. No.: 001 Rx (100MG/5ML); 002 Rx (400MG/20ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2022Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: For the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double refractory to a proteasome inhibitor and an immunomodulatory agent
Exclusivity Protected Indication: For the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double refractory to a proteasome inhibitor and an immunomodulatory agent
Exclusivity Type: Orphan Drug ExclusivityNov 21, 2023Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: DARZALEX is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Exclusivity Protected Indication: DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Exclusivity Type: Orphan Drug ExclusivityJun 16, 2024Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: DARZALEX is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Exclusivity Protected Indication: In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, not including any overlap with the exclusivity awarded for the 2015 approval for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and immunomodulary agent or are double refractory to a proteasome inhibitor and immunomodulatory agent.
Exclusivity Type: Orphan Drug ExclusivityMay 7, 2025Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: DARZALEX is indicated in combination with bortezomib, melphalen, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Exclusivity Protected Indication: In combination with bortezomib, melphalen, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
Exclusivity Type: Orphan Drug ExclusivitySep 26, 2026Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: Treatment of adult patients with multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy; in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor (PI); and as monotherapy, in patients who have received at least 3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immodulatory agent.
Exclusivity Protected Indication: Indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant

Janssen Biotech, Inc.
Darzalex Faspro (Injection) (Subcutaneous) daratumumab and hyaluronidase-fihj
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD38-directed cytolytic antibody
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761145  Prod. No.: 001 Rx (1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 15, 2028Orphan Designation: treatment of light-chain (AL) amyloidosis
Approved Labeled Indication: in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis
Exclusivity Protected Indication: treatment of adult patients with newly diagnosed light chain (AL) amyloidosis

Janssen Biotech, Inc.
Remicade (For Injection) (Intravenous) infliximab
Drug Classes: Immunological Agents:Immunosuppressants
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 103772  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 24, 2005Orphan Designation: Treatment of Crohn's disease
Approved Labeled Indication: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s).
Exclusivity Type: Orphan Drug ExclusivityMay 19, 2013Orphan Designation: Treatment of pediatric (0 to 16 years of age) Crohn's Disease
Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2018Orphan Designation: Treatment of pediatric (0 to 16 years of age) ulcerative colitis
Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Janssen Biotech, Inc.
Simponi Aria (Injection) (Intravenous) golimumab
Drug Classes: Immunological Agents:Immunosuppressants
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125433  Prod. No.: 001 Rx (50MG/4ML (12.5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 29, 2027Orphan Designation: Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age.
Approved Labeled Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
Exclusivity Protected Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age

Juno Therapeutics, Inc. a Bristol Myer-Squibb Company
Breyanzi (Injection) (Intravenous) lisocabtagene maraleucel
NDA Applicant: Juno Therapeutics, Inc. a Bristol Myer-Squibb Company      BLA No.: 125714  Prod. No.: 001 Rx (4.6ML/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan Designation: Treatment of primary mediastinal large B-cell lymphoma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan Designation: Treatment of follicular lymphoma (FL)
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy



Last edited: 15 November 2022
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