Alkermes settles VIVITROL patent litigation with Teva; generic entry January 2027

Alkermes plc.

Teva granted license to market generic VIVITROL in U.S. starting Jan 15, 2027, or earlier under certain circumstances.
Settlement resolves lawsuit filed Sep 2020; trial completed Mar 2023; patent expires 2029.
Agreement subject to FTC and DOJ review; parties will file joint stipulation to dismiss litigation.
Financial terms not disclosed; license is non-exclusive, royalty-free, limited to Teva's ANDA product.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.95

Alkermes plc. entered into Confidential Settlement and License Agreement with Teva Pharmaceuticals USA, Inc. (effective 2023-08-29).

Action: entry
Agreement: settlement
Counterparty: Teva Pharmaceuticals USA, Inc.
Effective: 2023-08-29

Exact text from the filing

On August 29, 2023, Alkermes, Inc. and Alkermes Pharma Ireland Limited, subsidiaries of Alkermes plc (together, “Alkermes”), entered into a Confidential Settlement and License Agreement (the “Settlement Agreement”) with Teva Pharmaceuticals USA, Inc. (“Teva”, and together with Alkermes, the “parties”) relating to Alkermes’ product VIVITROL ® (naltrexone for extended-release injectable suspension).

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Alkermes plc. filing history →

Source: SEC EDGAR

accession 0000950170-23-045176

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