ABBVIE INC (ABBV)

Expiry of Patent US8298556 related to KYBELLA

The patent US8298556 pertaining to KYBELLA is set to expire on August 3, 2025. KYBELLA, developed by Kythera Biopharmaceuticals and later acquired by Allergan, is a prescription medication used for the improvement of the appearance of moderate to severe fat beneath the chin, known as submental fat. The expiration of this patent may have significant implications for market competition, potentially allowing other companies to develop similar products or generics, which could affect Allergan's revenue from KYBELLA.

Expected Completion of Clinical Trial Assessing Linaclotide in Pediatric Functional Constipation

The clinical trial assessing Linaclotide for the treatment of pediatric functional constipation is projected to complete on September 1, 2025. The trial, led by AbbVie, focuses on evaluating adverse events and changes in disease activity among pediatric participants aged 6 months to less than 2 years. Linaclotide, an approved therapy for functional constipation, is being studied due to the lack of pharmacological treatments for this condition in children. With 19 participants enrolled across multiple sites, this Phase 2 trial includes a placebo group to better gauge therapy effectiveness. As it stands, the trial is actively not recruiting new participants.

• www.clinicaltrials.gov/study/NCT05760313

Completion of Clinical Trial for Venetoclax and Azacitidine Study

The clinical trial studying the combination of venetoclax and azacitidine (AZA) for the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) is expected to be completed on September 10, 2025. Venetoclax is an investigational drug aimed at improving treatment outcomes for MDS, a disorder that affects blood cell production and may progress to acute myeloid leukemia. The trial involves approximately 500 participants across 220 sites worldwide, comparing the venetoclax and AZA combination to AZA with a placebo. The trial is currently active and not recruiting new participants.

• www.clinicaltrials.gov/study/NCT04401748

Patent US9539250 Expiration for BAXDELA

The US patent US9539250, associated with the antibiotic BAXDELA, is set to expire on October 7, 2025. Assigned to AbbVie Inc and Melinta Subsidiary Corp, this patent covers a crystalline form of the drug, its production methods, and therapeutic applications. The expiration may allow for increased competition in the antibiotic market, potentially impacting AbbVie and Melinta’s market share and revenue from BAXDELA.

Expiration of Patent US8283379 for NAMZARIC

The patent US8283379 for the product NAMZARIC is set to expire on November 22, 2025. NAMZARIC, a combination of donepezil and memantine, is used in the treatment of Alzheimer’s disease. The expiration of this patent may allow for the entry of generic versions of the drug, which could significantly impact the market and revenue for the related companies.

Expiration of Patent US8293794 for NAMZARIC

The patent US8293794 for NAMZARIC, assigned to Adamas Pharmaceuticals Inc and AbbVie Inc, is set to expire on November 22, 2025. NAMZARIC offers innovative treatment methods for CNS-related conditions, particularly Alzheimer's disease. The expiration of this patent may lead to increased competition in the market for cognitive enhancing therapies, potentially impacting Adamas Pharmaceuticals' revenue and market share.

Patent US8173708 Expiry for NAMZARIC

Patent US8173708 for NAMZARIC is set to expire on November 22, 2025. NAMZARIC is a combination medication approved for the treatment of Alzheimer's disease, combining donepezil and memantine to enhance cognitive functioning. The expiration of its patent may impact the market landscape, potentially leading to the entry of generic competitors, which could affect revenue for the holding company.

NAMZARIC Patent Expiration (US8598233) on November 22, 2025

The patent for NAMZARIC, a once-daily oral medication containing memantine for treating dementia, particularly Alzheimer's disease, will expire on November 22, 2025. This expiration may affect its market position and competitive dynamics, as generic alternatives could enter the market, impacting revenues for Adamas Pharmaceuticals Inc and AbbVie Inc. The patent (US8598233) covers the extended-release formulation, which provides a distinct pharmacokinetic profile compared to immediate-release forms of memantine.

Expected Completion of Clinical Trial for VR and Linaclotide in IBS-C

AbbVie’s clinical trial exploring the efficacy of linaclotide for treating functional constipation in pediatric patients is expected to complete by December 1, 2025. The study, involving approximately 123 participants aged 2 to 5 years, compares linaclotide against placebo over a 12-week period followed by a long-term safety extension. Linaclotide is currently the only pharmacological option being evaluated for this age group, highlighting its potential significance in addressing a common health issue among children. The trial is categorized as active but not recruiting participants at this stage.

Patent US7112592 for AVYCAZ Expires

Patent US7112592 for AVYCAZ, an anti-bacterial drug by AbbVie Inc, is set to expire on January 7, 2026. This patent, assigned to Allergan Pharmaceuticals, covers new heterocyclic compounds used in the drug's formulation. The expiration may open the market to generic competitors, thereby impacting AbbVie's revenue from AVYCAZ significantly.