Generic names starting with "T"

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.


tafasitamab-cxix (For Injection) (Intravenous) Monjuvi
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)

tagraxofusp-erzs (Injection) (Intravenous) Elzonris
NDA Applicant: Stemline Therapeutics Inc      BLA No.: 761116  Prod. No.: 001 Rx (1,000MCG/1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2025Orphan Designation: Treatment of blastic plasmacytoid dendritic cell neoplasm
Approved Labeled Indication: ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
Exclusivity Protected Indication: ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.

Talimogene laherparepvec (For Injection) (Intralesional) Imlygic
NDA Applicant: Amgen, Inc.      BLA No.: 125518  Prod. No.: 001 Rx (100 MILLION PFU/ML); 002 Rx (1 MILLION PFU/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 27, 2022Orphan Designation: Treatment of stage IIb-stage IV melanoma
Approved Labeled Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery
Exclusivity Protected Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery

tbo-filgrastim (Injection) (Subcutaneous) Granix
NDA Applicant: Sicor Biotech UAB      BLA No.: 125294  Prod. No.: 001 Rx (300MCG/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityAug 29, 2024 

teprotumumab-trbw (For Injection) (Intravenous) Tepezza
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 761143  Prod. No.: 001 Rx (500MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 21, 2027Orphan Designation: Treatment of active thyroid eye disease
Approved Labeled Indication: TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
Exclusivity Protected Indication: For the treatment of active Thyroid Eye Disease

thyrotropin alfa (For Injection) (Intramuscular) Thyrogen
NDA Applicant: Genzyme Corporation      BLA No.: 020898  Prod. No.: 001 Rx (0.9MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 30, 2005Orphan Designation: As an adjunct in the diagnosis of thyroid cancer.
Approved Labeled Indication: As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer.
Exclusivity Type: Orphan Drug ExclusivityDec 14, 2014Orphan Designation: Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid
Approved Labeled Indication: For use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer

Tisagenlecleucel (Injection) (Intravenous) Kymriah
Drug Classes: CD19-directed genetically modified autologous T-cells
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125646  Prod. No.: 001 Rx (0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 1, 2025Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma
Exclusivity Protected Indication: For treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy.

tocilizumab (; Injection) (; Intravenous) Actemra
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-6 (IL-6) receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125276  Prod. No.: 002 Rx (200MG/10ML (20MG/ML)); 003 Rx (400MG/20ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Approved Labeled Indication: ACTEMRA_ (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2024Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome
Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug ExclusivityMar 4, 2028Orphan Designation: Treatment of systemic sclerosis
Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease
Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

tocilizumab (Injection) (Subcutaneous) Actemra
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-6 (IL-6) receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125472  Prod. No.: 001 Rx (162MG/0.9ML); 002 Rx (162MG/0.9ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Approved Labeled Indication: ACTEMRA_ (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2024Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome
Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug ExclusivityMar 4, 2028Orphan Designation: Treatment of systemic sclerosis
Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease
Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

tositumomab and iodine I-131 tositumomab (Injection) (Intravenous) Bexxar
Drug Classes: CD20-directed radiotherapeutic antibody
NDA Applicant: GlaxoSmithKline LLC      BLA No.: 125011  Prod. No.: 001 Disc (35MG); 002 Disc (225MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 27, 2010Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma.
Approved Labeled Indication: Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy

trastuzumab (For Injection) (Intravenous) Herceptin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == HER2/neu receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 103792  Prod. No.: 002 Rx (150MG) BLA No.: 103792  Prod. No.: 001 Disc (420MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 20, 2017Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction
Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease



Last edited: 15 November 2022
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