SUPERNUS PHARMACEUTICALS INC (SUPN)

Expiration of Patent US8895614 for OSMOLEX ER

The patent US8895614 for OSMOLEX ER, related to a method of administering amantadine with modified release characteristics, is set to expire today. This patent is key for Adamas Pharma LLC and Supernus Pharmaceuticals Inc., as it protects the formulation's unique release profile which allows once-daily dosing, potentially impacting market competitiveness and product exclusivity. The expiration may enable generic alternatives to enter the market, affecting revenue for Adamas Pharma.

Patent US8895615 Expiration for GOCOVRI

Patent US8895615 related to GOCOVRI, a drug composed of amantadine for treating Parkinson's disease and other conditions, is set to expire on November 23, 2025. The patent, assigned to Adamas Pharma LLC and Supernus Pharmaceuticals Inc, covers formulations that enhance the release of amantadine, critical for its therapeutic effect. The expiration may lead to increased competition from generic versions, potentially impacting revenue for Adamas and Supernus as the market landscape changes.

Expiration of Patent US8574626 for OSMOLEX ER

The patent US8574626, associated with OSMOLEX ER, is scheduled to expire on November 28, 2025. This patent covers an osmotic device that releases amantadine in a controlled manner, which is crucial for the efficacy of the drug. The device's design allows for a custom drug release profile, contributing to its therapeutic effectiveness. The expiration could enable generic competition, impacting the market position and revenue streams for Supernus Pharmaceuticals Inc and its partner Osmotica Kereskedelmi es Szolgaltato KFT.

Expected completion of clinical trial for SPN-812 in preschool-age children with ADHD

Supernus Pharmaceuticals, Inc. expects to complete a clinical trial evaluating SPN-812, an extended-release capsule indicated for the treatment of ADHD, in preschool-age children by December 1, 2025. This study involves a randomized, double-blind, placebo-controlled design, enrolling approximately 286 participants aged 4 to 5 years. The trial is currently in the recruitment phase, with treatment lasting 6 weeks. Successful outcomes may provide further evidence for the drug's efficacy and tolerability, impacting Supernus's market position in ADHD therapies.

• www.clinicaltrials.gov/study/NCT04781140

Expected Clinical Trial Completion for SPN-812 Study

Supernus Pharmaceuticals, Inc. is expected to complete the open-label study evaluating the long-term safety and efficacy of SPN-812 (Viloxazine Extended-release Capsule) by September 1, 2026. This multicenter study focuses on pediatric subjects with ADHD who have previously participated in earlier trials. It assesses the drug's safety and efficacy through both Optimization and Maintenance phases, with an enrollment of approximately 1,400 participants. The study is currently active but not recruiting new subjects, following earlier Phase 2 and Phase 3 trials. Completion of this study may provide critical data that could influence future market acceptance of SPN-812 in treating ADHD.

• www.clinicaltrials.gov/study/NCT02736656

Completion of BIS-001-ER Clinical Trial

Supernus Pharmaceuticals, Inc. is expected to complete its clinical trial NCT03474770 for BIS-001-ER on December 30, 2026. The trial, active but not recruiting, aims to evaluate the safety of BIS-001-ER as an add-on therapy for adults suffering from Focal Impaired Awareness Seizures (FIAS) and demonstrate its effectiveness in reducing seizures. The study commenced on April 10, 2018, with an enrollment of 16 participants across phases 1 and 2.

• www.clinicaltrials.gov/study/NCT03474770

Expiration of Patent US10220042 for OXTELLAR XR

Supernus Pharmaceuticals Inc. will face generic competition following the expiration of Patent US10220042 for OXTELLAR XR on April 13, 2027. OXTELLAR XR is a controlled-release formulation of oxcarbazepine, designed for once-a-day administration. The patent covers novel compositions that improve drug release profiles, which have contributed to the product's market value. The expiration may materially impact Supernus’ revenue, as market entry by generic manufacturers could lead to significant price reductions and increased competition in the epilepsy treatment market.

Expiration of Patent US9622983 for TROKENDI XR

The patent US9622983 for TROKENDI XR, assigned to Supernus Pharmaceuticals Inc, is set to expire on November 16, 2027. TROKENDI XR is a pharmaceutical composition of topiramate designed for once-a-day oral administration, allowing for a sustained-release delivery of the active ingredient. The anticipated expiration of this patent may open the market to generics, potentially impacting Supernus Pharmaceuticals' revenue from this product significantly.

Expiration of Patent US8389578 for GOCOVRI

The patent US8389578 related to GOCOVRI, a treatment for neurological disorders, will expire on January 22, 2028. This expiration could impact the competitive landscape for Adamas Pharma LLC and Supernus Pharmaceuticals Inc, as it may allow for the introduction of generic versions of GOCOVRI, thereby affecting their market share and revenues.

Patent Expiration for OSMOLEX ER

Adamas Pharma LLC and Supernus Pharmaceuticals Inc's patent for OSMOLEX ER, US8389578, is set to expire on January 22, 2028. OSMOLEX ER is used for treating neurological disorders, which underscores the strategic importance of the patent to the companies involved. Its expiration could lead to increased competition from generic alternatives, potentially impacting market share and revenues for both companies.