Latest Generic Competition News

Mayne Pharma has settled its final US Paragraph IV patent dispute over IMVEXXY with Teva, setting a potential generic entry date of 2 September 2032. The agreement removes ongoing litigation without an upfront payment, while leaving court approval and earlier-entry provisions to resolve.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.

CSL Limited’s FY2026 results reveal modest revenue growth offset by a multibillion-dollar statutory loss driven by restructuring and impairments, alongside a maintained dividend and a strategic focus on sustainable growth.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

Mayne Pharma’s third quarter results show modest revenue growth but a sharp improvement in cash flow and earnings, powered by the strong launch of DistributeRx and robust Women’s Health sales.

Actinogen Medical’s pivotal XanaMIA trial clears a key interim hurdle with the Data Monitoring Committee endorsing continuation, while a $16.8 million capital raise and non-dilutive funding bolster its balance sheet ahead of final results due November 2026.

AdAlta Limited has been granted a key Canadian patent for its anti-fibrotic drug AD-214, completing its composition of matter protection across all major commercial markets. This milestone strengthens the company’s intellectual property portfolio and underpins its commercial strategy for AD-214.

CSL Limited has released its half-year results showing a slight revenue decline amid ongoing transformation efforts, while maintaining its full-year guidance and expanding its share buyback program.

CSL Limited reported a 7% decline in underlying NPATA to US$1.9 billion for the half-year, weighed down by restructuring costs and impairments, yet maintains full-year guidance and expands its share buy-back program.

CSL Limited reported a sharp 80% drop in net profit for the half year ended December 2025, driven by significant restructuring and impairment charges, yet maintained its growth guidance and dividend payout.

Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.

CSL Limited posted a robust half-year performance with NPATA rising 5% at constant currency, driven by strong growth in CSL Behring and CSL Vifor despite challenges in its influenza vaccine segment. The company reaffirmed its FY25 guidance, anticipating double-digit earnings growth.