Axsome Therapeutics Resolves Generic Patent Litigation With Teva Over Depression Drug, Analyst Maintains Axsome As 'Top Pick For 2025'

On Monday, Axsome Therapeutics, Inc. AXSM signed a settlement agreement with Teva Pharmaceuticals Inc TEVA.

The settlement resolves all patent litigation related to Axsome’s Auvelity (dextromethorphan HBr – bupropion HCl) product.

Auvelity is approved in the U.S. for major depressive disorder.

The litigation resulted from Teva submitting an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Auvelity in the U.S. before the expiration of applicable Axsome patents.

Also Read: Axsome Reveals Data From Alzheimer’s Studies, Analyst Sees Hope Despite Mixed Trial Results

Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of Auvelity beginning on or after March 31, 2039, if pediatric exclusivity is granted for Auvelity, or on or after September 30, 2038, if no pediatric exclusivity is granted.

The parties will terminate all ongoing litigation between Axsome and Teva regarding Auvelity patents pending in the U.S. District Court for the District of New Jersey.

In January, Axsome Therapeutics reported preliminary Auvelity net product sales are expected to be approximately $92.6 million and $291.4 million for the fourth quarter and full year of 2024, respectively.

Recently, the FDA approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.

“Axsome is our top pick for 2025,” William Blair writes. Analyst Myles Minter reiterates the Outperform rating based on favorable litigation settlement and clarity on Auvelity’s generic launch timing.

“We also remain impressed with the Auvelity launch, which showed 15% growth in revenue over the prior quarter and is annualizing about $370 million after two years of launch,” William Blair adds.

Axsome now has three commercial products with the approval of Symbravo for migraines. While investors are mainly watching Auvelity's rollout for depression and its potential use in Alzheimer's-related agitation, analyst Minter writes Symbravo's potential in treating acute migraines is being overlooked.

William Blair also views Axsome as a takeout candidate with Johnson & Johnson buying Intra-Cellular Therapies Inc. for $14.6 billion.

Needham analyst Ami Fadia reiterates Axsome Therapeutics with a Buy and maintains a $133 price target.

Price Action: AXSM stock is up 24.6% at $131.77 at last check Monday.

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