Part of HIKMA PHARMACEUTICALS PLC
British multinational pharmaceutical company headquartered in London, manufacturing non-branded generic and in-licensed pharmaceutical products; founded in 1978 in Amman, Jordan. Listed on the London Stock Exchange (HIK), FTSE 250 constituent.
Clinical Trials
20
3 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1978
Active, not recruiting
2
10.0%
Completed
14
70.0%
Not yet recruiting
1
5.0%
Recruiting
2
10.0%
Terminated
1
5.0%
- Pfizer reached settlements with Dexcel Pharma, Hikma Pharmaceuticals, and Cipla to extend tafamidis patent protection through June 1, 2031, preventing generic competition until early next decade. - The agreements ensure U.S. revenues for Vyndamax, which generated nearly $6.4 billion worldwide last year, will remain relatively stable from 2028 through mid-2031 instead of facing significant decline. - Tafamidis is the market-leading treatment for transthyretin-mediated amyloidosis cardiomyopathy, a rare heart disease that has proven to be a much larger commercial opportunity than previously anticipated. - The patent extension impacts the competitive landscape for other companies developing treatments for the same condition, including BridgeBio Pharma's Attruby and Alnylam Pharmaceuticals' Amvuttra.
- Hikma Pharmaceuticals has launched TYZAVAN™, the first FDA-approved ready-to-use vancomycin injection with room-temperature stability, eliminating preparation time in critical sepsis cases. - The glycopeptide antibiotic is indicated for septicemia, infective endocarditis, skin infections, bone infections, and lower respiratory tract infections in adults and pediatric patients over one month old. - TYZAVAN™ offers seven different strengths (0.5g-2g) with 16-month shelf life at room temperature, designed to address the urgent need for rapid antibiotic administration in sepsis where survival rates decrease by 15% after 87-113 minutes. - The ready-to-use formulation streamlines hospital workflows by eliminating compounding, thawing, and assembly steps while reducing medication errors and handling risks for healthcare teams.
- Hikma Pharmaceuticals launched STARJEMZA (ustekinumab-hmny) on November 6, 2025, marking the company's first biosimilar entry into the US market. - The biosimilar references Janssen's STELARA and is approved for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. - STARJEMZA became the seventh ustekinumab biosimilar to receive FDA approval on May 22, 2025, developed by Bio-Thera under a 2021 partnership agreement. - The launch represents a significant milestone for Hikma's biosimilar strategy and adds another treatment option for patients with inflammatory conditions.
- The FDA approved Ritedose Corporation's manufacturing and distribution of generic Tobramycin Inhalation Solution for treating Pseudomonas aeruginosa infections in cystic fibrosis patients aged six years and older. - This marks Ritedose's first cystic fibrosis product and establishes the company as having the largest nebulized drug portfolio in the United States. - The preservative-free formulation is packaged as 300 mg doses in 5 ml ampules and is now available for purchase, expanding affordable access to this critical antibiotic therapy. - Ritedose licensed the drug's ANDA from Hikma Pharmaceuticals and represents the third generic drug approval for the company in 2025, following formoterol and albuterol approvals.
- Hikma Pharmaceuticals and Celltrion Inc. have signed exclusive licensing agreements to bring six biosimilar treatments to the Middle East and North Africa region. - The partnership covers key therapeutic areas including oncology, immunology, ophthalmology, orthopedics, and allergy care, with Hikma holding exclusive marketing rights across MENA markets. - The collaboration aims to provide cost-effective alternatives to complex biologic drugs, making vital treatments more accessible to patients who previously faced barriers due to high costs or limited availability.
- The Supreme Court is considering a pivotal case involving "skinny labels" that could redefine how generic drug manufacturers avoid patent infringement claims through selective labeling practices. - The Federal Circuit reversed a district court dismissal in Amarin Pharma v. Hikma Pharmaceuticals, finding that generic labeling combined with marketing statements could constitute induced infringement despite skinny labeling. - The Court's decision could significantly impact generic pharmaceutical labeling, marketing practices, and the legal standards for proving induced infringement in method-of-treatment patent cases. - Generic manufacturers may face increased scrutiny of their promotional materials and need to adopt more restrictive communication practices if the Court establishes new precedent on intent to induce infringement.
- Amgen and Accord BioPharma reached a settlement agreement on July 16, 2025, resolving patent litigation over Accord's denosumab biosimilar INTP23, with Accord agreeing to delay U.S. market entry until October 1, 2025. - The settlement represents the fourth resolved denosumab biosimilar litigation for Amgen, which has filed eight total BPCIA cases to protect its Prolia® and Xgeva® franchises worth over $4.3 billion in annual U.S. sales. - Three denosumab biosimilars from Sandoz, Fresenius Kabi, and Celltrion have already launched in the U.S. market following their respective settlements with Amgen in 2025.
- Hikma Pharmaceuticals received FDA approval for TYZAVAN™, the first ready-to-infuse vancomycin formulation that requires no preparation, targeting critical sepsis treatment where survival rates decrease by 15% after 87-113 minutes. - The glycopeptide antibiotic is indicated for septicemia, infective endocarditis, skin infections, bone infections, and lower respiratory tract infections in adults and pediatric patients over one month old. - TYZAVAN™ offers room-temperature stability with 16-month shelf life, seven dosing presentations (0.5g-2g), and compatibility with automated dispensing cabinets to streamline hospital workflows. - The US vancomycin injection market was valued at approximately $200 million in 2024, with sepsis affecting one person every 20 seconds and causing death every two minutes in the United States.
- Hikma Pharmaceuticals USA announces a $1 billion investment by 2030 to expand its US manufacturing and R&D capabilities for generic medicines. - The investment builds on the company's existing capacity to produce more than 12 billion finished doses annually across facilities in Ohio and New Jersey. - The expansion will strengthen Hikma's portfolio of over 800 medicines and enhance its position as a top three US supplier of sterile injectable medicines. - The initiative aims to address America's growing need for domestically produced, affordable generic medicines while supporting drug shortage solutions.
- Amgen filed three separate BPCIA patent infringement lawsuits in late June 2025 against companies developing denosumab biosimilars, including Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon. - The lawsuits allege infringement of 26-34 patents each and claim the defendants failed to comply with BPCIA "patent dance" requirements by withholding key manufacturing information. - These cases represent the sixth, seventh, and eighth denosumab biosimilar litigations by Amgen, following previous suits against Sandoz, Celltrion, Samsung Bioepis, Fresenius, and Accord Biopharma. - The targeted biosimilars include RGB-14-P/RGB-14-X (Hikma/Richter), HLX14 (Shanghai Henlius/Organon), and an unnamed Biocon product, all seeking to compete with Amgen's Prolia and Xgeva brands.
