Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 23, 2025 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older Exclusivity Protected Indication: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 3, 2030 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older Exclusivity Protected Indication: prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged 2 years to less than 12 years |
Tecartus (For Injection) (Intravenous) Brexucabtagene Autoleucel
NDA Applicant: Kite Pharma Inc. BLA No.: 125703 Prod. No.: 001 Rx (2_10^6 CAR-positive viable T cells per kg body weight)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 24, 2027 | Orphan Designation: Treatment of mantle cell lymphoma. Approved Labeled Indication: TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) Exclusivity Protected Indication: TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 1, 2028 | Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL) Approved Labeled Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) |
Tecentriq (Injection) (Intravenous) atezolizumab
NDA Applicant: Genentech, Inc. BLA No.: 761034 Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2026 | Orphan Designation: Treatment of small cell lung cancer (SCLC) Approved Labeled Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) Exclusivity Protected Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 30, 2027 | Orphan Designation: Treatment of Stage llb, llc, lll and IV melanoma Approved Labeled Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma Exclusivity Protected Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 9, 2029 | Orphan Designation: treatment of soft tissue sarcoma Approved Labeled Indication: as a single agent for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) Exclusivity Protected Indication: treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) |
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 |
Tepezza (For Injection) (Intravenous) teprotumumab-trbw
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 761143 Prod. No.: 001 Rx (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 21, 2027 | Orphan 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 |
Thrombate Iii (For Injection) (Intravenous) Antithrombin III (Human)
NDA Applicant: Grifols Therapeutics LLC BLA No.: 103196 Prod. No.: 001 Rx (500IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 30, 1998 | Orphan Designation: For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli. |
Thyrogen (For Injection) (Intramuscular) thyrotropin alfa
NDA Applicant: Genzyme Corporation BLA No.: 020898 Prod. No.: 001 Rx (0.9MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 30, 2005 | Orphan 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 Exclusivity | Dec 14, 2014 | Orphan 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 |
Trasylol (Injection) (Intravenous) aprotinin
NDA Applicant: Bayer HealthCare Pharmaceuticals Inc. BLA No.: 020304 Prod. No.: 001 Disc (1,000,000KIU/100ML (10,000KIU/ML)); 002 Disc (2,000,000KIU/200ML (10,000KIU/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 29, 2000 | Orphan Designation: For prophylactic use to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft surgery, and in selected cases of primary c |
Tretten (For Injection) (Intravenous) Coagulation Factor XIII A-Subunit (Recombinant)
NDA Applicant: Novo Nordisk Inc. BLA No.: 125398 Prod. No.: 001 Rx (2000 - 3125IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 23, 2020 | Orphan Designation: Prophylaxis of bleeding associated with congential factor XIII deficiency Approved Labeled Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency. Exclusivity Protected Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency. |
Trogarzo (Injection) (Intravenous) ibalizumab-uiyk
NDA Applicant: Theratechnologies Inc. BLA No.: 761065 Prod. No.: 001 Rx (200MG/1.33ML (150MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 6, 2025 | Orphan Designation: Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy Approved Labeled Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Exclusivity Protected Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. |
Trumenba (Injection) (Intramuscular) Meningococcal Group B Vaccine
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 125549 Prod. No.: 001 Rx (0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Oct 29, 2026 |
Tysabri (Injection) (Intravenous) natalizumab
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 |