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: Orphan Drug Exclusivity | Feb 28, 2029 | Orphan Designation: Treatment of multiple myeloma (MM) Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody |
| Exclusivity Type: Ref. Product Exclusivity | Feb 28, 2034 |
Janssen Biotech, Inc.
Darzalex (Injection) (Intravenous) daratumumab
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761036 Prod. No.: 001 Rx (100MG/5ML); 002 Rx (400MG/20ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2022 | Orphan 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 Exclusivity | Nov 21, 2023 | Orphan 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 Exclusivity | Jun 16, 2024 | Orphan 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 Exclusivity | May 7, 2025 | Orphan 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 Exclusivity | Sep 26, 2026 | Orphan 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
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761145 Prod. No.: 001 Rx (1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 15, 2028 | Orphan 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
NDA Applicant: Janssen Biotech, Inc. BLA No.: 103772 Prod. No.: 001 Rx (100MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 24, 2005 | Orphan 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 Exclusivity | May 19, 2013 | Orphan 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 Exclusivity | Sep 23, 2018 | Orphan 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
NDA Applicant: Janssen Biotech, Inc. BLA No.: 125433 Prod. No.: 001 Rx (50MG/4ML (12.5MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 29, 2027 | Orphan 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 |
Janssen Biotech, Inc.
Stelara (Injection) (Subcutaneous) ustekinumab
NDA Applicant: Janssen Biotech, Inc. BLA No.: 125261 Prod. No.: 001 Rx (45MG/0.5ML); 003 Rx (45MG/0.5ML); 004 Rx (90MG/ML) BLA No.: 125261 Prod. No.: 002 Disc (90MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6902734 [Extended 425 days (1.2 years)] Anti-IL-12 antibodies and compositions thereof Claim Types: Compound; Composition Pat. Sub. Date(s): None | Sep 25, 2023 | |
| Pat. No. 8852889 Cell culture process Claim Types: Process Pat. Sub. Date(s): None | Jul 6, 2032 | |
| Pat. No. 9217168 Methods of cell culture Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9475858 Cell culture process Claim Types: Process Pat. Sub. Date(s): None | Jul 6, 2032 | |
| Pat. No. 9663810 Methods of cell culture Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 10961307 Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody Claim Types: Method of use Pat. Sub. Date(s): None | Sep 24, 2039 |
Janssen Biotech, Inc.
Stelara (Injection) (Intravenous) ustekinumab
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761044 Prod. No.: 001 Rx (130MG/26ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6902734 [Extended 425 days (1.2 years)] Anti-IL-12 antibodies and compositions thereof Claim Types: Compound; Composition Pat. Sub. Date(s): None | Sep 25, 2023 | |
| Pat. No. 8852889 Cell culture process Claim Types: Process Pat. Sub. Date(s): None | Jul 6, 2032 | |
| Pat. No. 9217168 Methods of cell culture Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9475858 Cell culture process Claim Types: Process Pat. Sub. Date(s): None | Jul 6, 2032 | |
| Pat. No. 9663810 Methods of cell culture Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 10961307 Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody Claim Types: Method of use Pat. Sub. Date(s): None | Sep 24, 2039 |
Janssen Biotech, Inc.
Tecvayli (Injection) (Subcutaneous) teclistamab-cqyv
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761291 Prod. No.: 001 Rx (30MG/3ML (10MG/ML)); 002 Rx (153MG/1.7ML (90MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 25, 2029 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | Orphan 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 Exclusivity | Feb 5, 2028 | Orphan 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 |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | Orphan 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 Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of follicular lymphoma (FL) Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of primary mediastinal large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) , primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |