JNJJohnson & Johnson

Product Name Indication US EU US EU (Chemical Name) Approval Approval Filing Filing BALVERSA (erdafitinib) AKEEGA (niraparib/abiraterone) Treatment of Patients patients with Locally Advanced or M1 Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations (THOR) Castration-Sensitive Prostate Cancer (AMPLITUDE) • • CARVYKTI (ciltacabtagene autoleucel) Treatment CAPLYTA (lumateperone) Adjunctive treatment for Relapsed and Refactor multiple myeloma with 1-3 PL (CARTITUDE-4) • • DARZALEX (daratumumab) Treatment for frontline multiple myeloma transplant eligible (PERSEUS) • Major Depressive Disorder • DARZALEX (daratumumab) Treatment for frontline multiple myeloma transplant ineligible (CEPHEUS) • • DARZALEX (daratumumab) Treatment as subcutaneous monotherapy for high-risk smoldering multiple myeloma (AQUILA) • • EDURANT (rilpivirine) ICOTYDE (icotrokinra) Treatment for pediatric patients (2-12 years old) with HIV Psoriasis (ICONIC) • • INLEXZO (gemcitabine intravesical system) Treatment for non muscle invasive bladder cancer (SunRISe-1) • IMAAVY (nipocalimab) Treatment for Generalized Myasthenia Gravis (Vivacity MG3) • • IMAAVY (nipocalimab) Treatment for Generalized Myasthenia Gravis Pediatrics (VIBRANCE MG) • IMBRUVICA (ibrutinib) Treatment for frontline MCL (Triangle) • nipocalimab Treatment for Generalized Myasthenia Gravis • • OPSUMIT (macitentan) Treatment for pediatric pulmonary arterial hypertension (TOMORROW) • • OPSYNVI (macitentan/tadalafil STCT) Treatment for pulmonary arterial hypertension • • REKAMBYS Treatment for Adolescents HIV • RYBREVANT (amivantamab) In Combination with Chemotherapy for the First-Line Treatment of Adult Patients with Advanced Non-Small Cell Lung Cancer with Activating EGFR Exon 20 Insertion Mutations (PAPILLON) • • RYBREVANT (amivantamab) Treatment for subcutaneous (PALOMA-3) • • RYBREVANT / LAZCLUZE Treatment for Non-Small Cell Lung Cancer (MARIPOSA) • • RYBREVANT Treatment for Non-Small Cell Lung Cancer 2L (MARIPOSA-2) • • SIMPONI (golimumab) Treatment of Patients with Pediatric Ulcerative Colitis (PURSUIT 2) • • SPRAVATO (esketamine) monotherapy Treatment of Patients with Treatment Resistant Depression monotherapy (TRD4005) • STELARA (ustekinumab) Treatment of Patients with Pediatric Crohn's Disease • • STELARA (ustekinumab) Treatment of Patients with Pediatric Ulcerative Colitis (UNIFI JR) • • TECVAYLI (teclistamab) Multiple Myeloma 1-3PLs (MajesTEC-3) • TREMFYA (guselkumab) Treatment of Patients with Ulcerative Colitis (QUASAR) • • TREMFYA (guselkumab) Subcutaneous Induction for treatment of patients with Ulcerative Colitis (ASTRO) • • TREMFYA (guselkumab) Subcutaneous Induction for treatment of patients with Crohn's Disease (GRAVITI) • • TREMFYA (guselkumab) Treatment of Patients with Crohn's Disease (GALAXI) • • TREMFYA (guselkumab) Treatment of Patients with Pediatric Psoriasis (PROTOSTAR) • UPTRAVI (selexipag) • TREMFYA (guselkumab) Treatment of patients with Psoriatic Arthritis Structural Damage (APEX) • TREMFYA (guselkumab) Treatment of Patients with Pediatric Pulmonary Arterial Hypertension (SALTO) Juvenile Psoriatic Arthritis •

Beginning in January 2018, Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc. filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of INVEGA SUSTENNA before expiration of the Orange Book Listed Patent. The following entities are named defendants: Teva Pharmaceuticals USA, Inc.; Mylan Laboratories Limited; Pharmascience Inc.; Mallinckrodt PLC; Specgx LLC; Tolmar, Inc.; Accord Healthcare, Inc.; Qilu Pharmaceutical Co. Ltd.; and Qilu Pharma Inc.; Sun Pharmaceutical Industries Ltd.; and Sun Pharmaceutical Industries, Inc. The following U.S. patent is included in one or more cases: 9,439,906. In October 2020, the district court issued a decision in the case against Teva Pharmaceuticals USA, Inc., finding that United States Patent No. 9,439,906 is not invalid. Teva previously stipulated to infringement. Teva appealed the decision, and, in April 2024, the United States Court of Appeals for the Federal Circuit vacated and remanded the case to the district court for further proceedings. In November 2024, the district court issued its decision on remand, finding that United States Patent No. 9,439,906 is not invalid. Teva appealed to the Court of Appeals for the Federal Circuit, and oral argument is scheduled for April 2025. In February 2024, the district court issued a decision in the case against Tolmar Inc. finding that United States Patent No. 9,439,906 is not invalid. Tolmar previously stipulated to infringement. infringement of a subset of the claims, and based on a claim construction ruling, the district court entered a non-infringement order with respect to the remaining asserted claims. Tolmar has appealed the validity decision, and Janssen appealed the non-infringement decision. In November 2025, the court entered judgments against the Accord and Qilu defendants. In December 2025, Janssen and the Sun defendants entered into a confidential settlement agreement and a consent judgment was entered by the court.

To meet business objectives, the Company relies on both internal information technology (IT) systems and networks, and those of third parties and their vendors, to process and store sensitive data (including confidential research, business plans, financial information, intellectual property, and personal data that may be subject to legal protection) to ensure the continuity of the Company’s supply chain and operations, and as part of many of the products we deliver to customers. The extensive range of information security and cybersecurity threats, which affect companies globally, pose a persistent risk to the security and availability of these systems and networks, including to customer products that are connected to or rely on such systems and networks, and the confidentiality, integrity, and availability of the Company’s sensitive data. The Company assesses these threats, responds to attacks and breaches that it has experienced, and makes investments to increase internal protection, detection, and response capabilities, as well as ensure the Company’s third-party providers have required capabilities and controls, to address this risk. Because of the frequently changing attack techniques, along with the increased volume and sophistication of the attacks and increasing use and reliance on third parties, there is the potential for the Company to be adversely impacted. This impact could result in reputational, competitive, operational or other business harm as well as financial costs and regulatory action. The increasing use of AI and other emerging technology could also increase these risks. The Company maintains cybersecurity insurance in the event of an information security or cyber incident; however, the coverage may not be sufficient to cover all financial, legal, business or reputational losses.

The Company is organized into two business segments: Innovative Medicine and MedTech. The Innovative Medicine segment is focused on the following therapeutic areas: Oncology, Immunology, Neuroscience, Pulmonary Hypertension, Infectious Diseases, Neuroscience, Oncology, Pulmonary Hypertension, and Cardiovascular and Metabolic. Products in this segment are distributed directly to retailers, wholesalers, distributors, hospitals and healthcare professionals for prescription use. The MedTech segment includes a broad portfolio of products used in the Surgery, Orthopaedic, Surgery, Cardiovascular (previously referred to as Interventional Solutions) and Vision fields. These products are distributed to wholesalers, hospitals and retailers, and used principally in the professional fields by physicians, nurses, hospitals, eye care professionals and clinics. In October 2025, the Company announced its intention to separate its Orthopaedics business. The Company intends to explore multiple paths to effect the planned separation with a targeted completion within 18 to 24 months after the initial announcement.