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Hikma Pharmaceuticals PLC (HIK) delivers essential medicines to global markets through branded generics and innovative treatments. This news hub provides investors and healthcare professionals with timely updates on regulatory milestones, product developments, and strategic partnerships shaping this UK-based pharmaceutical leader.
Track HIK's progress in addressing critical healthcare needs, including opioid overdose reversal solutions and expanded access to generics. Our curated news collection features earnings reports, manufacturing updates, and analysis of market trends affecting this multinational producer.
Discover verified information on FDA approvals, partnership announcements with organizations like Emergent BioSolutions, and operational expansions across North American and MENA regions. All content maintains strict editorial standards to support informed decision-making.
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Hikma Pharmaceuticals has acquired the FDA-approved ANDA for trametinib tablets from Novugen, securing 180 days of US generic market sales exclusivity. The agreement positions Hikma to handle US sales and marketing while Novugen manages manufacturing and supply.
Trametinib, an oral kinase inhibitor for cancer treatment, generated approximately $436 million in US sales under the brand name Mekinist® in the 12 months ending December 2024. This strategic acquisition strengthens Hikma's generics portfolio in oncology and expands its pipeline of essential medicines.
The partnership aims to increase access to cost-efficient cancer treatments in the US market, where Hikma maintains a strong presence in complex generic technologies, including being the largest supplier by volume of nasal sprays.
Hikma Pharmaceuticals has announced an exclusive six-year commercial partnership with Emergent BioSolutions for the sale of KLOXXADO® (naloxone HCl nasal spray 8 mg) in the U.S. and Canada. KLOXXADO® received FDA approval in April 2021 for emergency treatment of suspected opioid overdose in adults and pediatric patients.
Under the agreement, Emergent will incorporate KLOXXADO® into its naloxone product portfolio and handle all North American sales and marketing. Hikma will continue manufacturing the 8 mg naloxone HCl nasal spray at its Columbus, Ohio facility as the exclusive supplier to Emergent. The partnership combines Hikma's manufacturing capabilities with Emergent's established commercial expertise in naloxone nasal spray distribution.
Hikma will maintain production and marketing of its other naloxone products, including injectable vials and prefilled syringes, ensuring wide accessibility to healthcare providers and the public health community.
Hikma Pharmaceuticals participated in a naloxone training event with U.S. Congressman Buddy Carter ahead of National Fentanyl Awareness and Prevention Day. The event, held at Groves High School in Savannah, Georgia, marks Hikma's milestone of donating over 600,000 doses of naloxone in the past three years. Hikma is working with government officials and the White House Office of National Drug Control Policy to expand access to naloxone, a vital tool for reversing overdoses.
Hikma manufactures multiple forms of naloxone, including generic injectable vials, prefilled syringes, and KLOXXADO® (naloxone 8mg) intranasal spray. The company's Hikma Community Health initiative partners with frontline organizations to expand naloxone access through donations, partnerships, and awareness programs. Hikma also provides a Co-Pay Assistance Program for KLOXXADO® to increase accessibility and reduce out-of-pocket costs.
Hikma Pharmaceuticals PLC announces the shelf-life extension of KLOXXADO® (naloxone HCl) nasal spray 8mg from 24 to 36 months. This change applies to products manufactured from March 2024 onwards. KLOXXADO® contains twice the naloxone dose of Narcan® Nasal Spray 4mg, offering a important treatment option for opioid overdose reversal.
The extended shelf-life is particularly beneficial for frontline responders and individuals carrying KLOXXADO® for emergency use. This development comes as organizations like the CDC and American Medical Association note that higher doses of naloxone may be necessary to counteract poisoning from illicit fentanyl and other synthetic opioids. Hikma emphasizes its role in combating the opioid crisis, especially as International Overdose Awareness Day approaches on August 31st.