Table: q1_q4_2022_prescription_drugs_intro_to_market , manufacturer_name like J*

A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z  *

manufacturer_name ndc_number drug_product_description date_introduced_to_market wac_at_introduction marketing_pricing_plan_description marketing_pricing_plan_non_public_indicator estimated_number_of_patients breakthrough_therapy_indicator priority_review_indicator acquisition_date acquisition_price acquisition_price_non_public_indicator acquisition_price_comment general_comments supporting_documents
Janssen Biotech, Inc. 57894011102 CARVYKTI™ Strength: 0.5-1.0×10^6 CAR+ viable T-cells per kg of body wt, with a ma dose of 1×10^8 CAR+ viable T-cells, 5% DMSO, Form: Suspension for intravenous infusion, ,Package Size 30mL 2022-03-03 465000.0000 While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent and anti-CD 38 therapy. The WAC is set at $465,000. The list price of CARVYKTI™ does not include discounts which may be available through Medicaid, Medicare, and commercial insurance. CARVYKTI™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. None 34920 1 1 None None None None There are 34,920 newly diagnosed patients with multiple myeloma each year. CARVYKTI™ is indicated for patients with relapsed refractory disease. Exact information for the CARVYKTI™ indicated patient population is not available in the public domain. None
Janssen Biotech, Inc. 57894011101 CARVYKTI™ Strength: 0.5-1.0×10^6 CAR+ viable T-cells per kg of body wt, with a ma dose of 1×10^8 CAR+ viable T-cells, 5% DMSO, Form: Suspension for intravenous infusion, Package Size 70mL, 2022-03-03 465000.0000 While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent and anti-CD 38 therapy. The WAC is set at $465,000. The list price of CARVYKTI™ does not include discounts which may be available through Medicaid, Medicare, and commercial insurance. CARVYKTI™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. None 34920 1 1 None None None None There are 34,920 newly diagnosed patients with multiple myeloma each year. CARVYKTI™ is indicated for patients with relapsed refractory disease. Exact information for the CARVYKTI™ indicated patient population is not available in the public domain. None
Janssen Biotech, Inc. 57894045001 TECVAYLI™ (teclistamab) Strength: 153 mg Form: 1 single vial Package Size: 1 2022-10-26 9027.0000 While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 153 mg/1.7 mL vial at $9,027.00. The list price of TECVAYLI will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs. In August 2022, the European Commission (EC) granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TECVAYLI in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices. None 34920 1 1 None None None None There are 34,920 newly diagnosed patients with multiple myeloma each year. TECVAYLI is indicated for patients with relapsed refractory disease. Exact information for the TECVAYLI indicated population is not available in the public domain. None
Janssen Biotech, Inc. 57894044901 TECVAYLI™ (teclistamab) Strength: 30 mg Form: 1 single vial Package Size: 1 2022-10-26 1770.0000 While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 30 mg/3 mL vial at $1,770.00. The list price of TECVAYLI will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs. In August 2022, the European Commission (EC) granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TECVAYLI in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices. None 34920 1 1 None None None None There are 34,920 newly diagnosed patients with multiple myeloma each year. TECVAYLI is indicated for patients with relapsed refractory disease. Exact information for the TECVAYLI indicated population is not available in the public domain. None