Last updated: February 17, 2026
What is the core dispute?
Neurocrine Biosciences, Inc. (Neurocrine) initiated patent litigation against Lupin Limited (Lupin) and its U.S. subsidiary, Lupin Pharmaceuticals, Inc., concerning the blockbuster drug Ingrezza (valbenazine). The lawsuit, filed in the United States District Court for the District of Delaware on May 12, 2021, alleges that Lupin’s proposed generic version of Ingrezza infringes on Neurocrine’s U.S. Patent No. 9,925,123. Neurocrine seeks to prevent Lupin from marketing its generic product in the United States.
What are the key patents involved?
The primary patent at issue is U.S. Patent No. 9,925,123, titled "Method of treating tardive dyskinesia." This patent claims specific methods of treating tardive dyskinesia (TD) using valbenazine ditartrate. Neurocrine asserts that Lupin’s Abbreviated New Drug Application (ANDA) for its generic valbenazine ditartrate product infringes this patent.
Neurocrine also holds other patents related to valbenazine and its use, which may become relevant in future proceedings or through potential supplemental filings. However, the initial infringement allegations focus on the '123 patent.
What is the status of the litigation?
The litigation is in its early stages. Following the filing of the complaint, Lupin is expected to file an answer and potentially a counterclaim. Discovery, including the exchange of documents and witness depositions, will likely commence. The case is assigned to Judge Richard G. Andrews, known for managing patent cases efficiently. A Markman hearing, where the court interprets the disputed patent claims, is a common next step in such litigation and would typically occur after initial pleadings and some discovery.
As of the filing date, Lupin had not yet launched its generic product, indicating that the litigation is a pre-launch challenge by Neurocrine.
What is the commercial significance of Ingrezza?
Ingrezza is Neurocrine’s flagship product and a critical revenue driver. It is approved for the treatment of tardive dyskinesia and, more recently, tardive dyskinesia. In 2023, Ingrezza generated approximately $1.9 billion in net sales, representing substantial growth from previous years [1]. The drug’s success is attributed to its efficacy in treating these neurological disorders and its favorable market positioning. The impending expiration of patents protecting Ingrezza is a significant concern for Neurocrine, as generic competition can lead to a sharp decline in revenue.
What are the grounds for Neurocrine's infringement claim?
Neurocrine alleges that Lupin’s ANDA for generic valbenazine ditartrate infringes U.S. Patent No. 9,925,123. Specifically, Neurocrine contends that Lupin’s proposed product and method of use fall within the scope of one or more claims of the '123 patent. The '123 patent describes a method of treating tardive dyskinesia by administering a specific dose of valbenazine. Neurocrine must demonstrate that Lupin’s proposed generic product, when used as intended, performs the patented method.
What defenses might Lupin employ?
Lupin is expected to challenge the validity and enforceability of the '123 patent. Common defenses in Hatch-Waxman patent litigation include:
- Non-infringement: Lupin will argue that its proposed generic product and method of use do not fall within the scope of the asserted patent claims. This may involve technical arguments about the drug's formulation, dosage, or therapeutic effect.
- Invalidity: Lupin may argue that the '123 patent is invalid based on prior art that predates the patent’s filing date or on other grounds such as obviousness or lack of enablement.
- Inequitable Conduct: Although a high bar to prove, Lupin could potentially allege that Neurocrine engaged in inequitable conduct before the U.S. Patent and Trademark Office (USPTO) during the prosecution of the '123 patent.
What are the potential outcomes of the litigation?
The litigation can result in several outcomes:
- Permanent Injunction: If Neurocrine prevails on infringement and validity, a court may issue a permanent injunction preventing Lupin from marketing its generic product for a period determined by the court, potentially extending beyond the patent’s stated expiration if there is a finding of willful infringement or other aggravating factors.
- Settlement: The parties may reach a settlement agreement. Such agreements often involve a license for Lupin to market its generic product on a specified date, typically before the patent’s expiration, in exchange for royalty payments to Neurocrine. These settlements are often scrutinized by the U.S. Federal Trade Commission (FTC) for potential anti-competitive effects.
- Dismissal: The case could be dismissed if Neurocrine fails to establish infringement or if Lupin successfully invalidates the patent.
- Limited Market Entry: Lupin might be permitted to launch its generic product, but potentially with restrictions or a delay, if the court finds partial infringement or invalidity of certain claims.
What is the potential impact on Neurocrine's market exclusivity?
The outcome of this litigation directly impacts Neurocrine's market exclusivity for Ingrezza. A successful defense against Lupin’s ANDA would preserve Neurocrine's market position. Conversely, if Lupin prevails, it could lead to the earlier introduction of generic competition, significantly eroding Ingrezza’s market share and revenue. The '123 patent has a statutory expiration date of 2034, subject to potential patent term extensions. The generic launch date would hinge on the litigation's resolution and any potential patent challenges.
What is the timeline for resolution?
Patent litigation in the U.S. District Court for the District of Delaware, particularly before Judge Andrews, can take 18-30 months from filing to a final decision, although this can vary significantly. A Markman hearing typically occurs within 9-15 months of the initial complaint. Appeals to the U.S. Court of Appeals for the Federal Circuit can add additional time. Therefore, a definitive resolution of this case is unlikely before late 2022 or 2023, with appeals potentially extending the timeline further.
Key Takeaways
- Neurocrine Biosciences is defending its key drug Ingrezza against a generic challenge from Lupin Limited.
- The core of the dispute revolves around U.S. Patent No. 9,925,123, which protects a method of treating tardive dyskinesia.
- Ingrezza is a significant revenue generator for Neurocrine, with $1.9 billion in 2023 sales, making patent protection critical.
- Lupin is expected to challenge the patent’s validity and argue non-infringement.
- The litigation timeline is projected to be 18-30 months for a district court decision, with potential appeals extending the resolution period.
FAQs
- When was Ingrezza first approved by the FDA?
Ingrezza was first approved by the U.S. Food and Drug Administration (FDA) on April 11, 2017, for the treatment of tardive dyskinesia.
- What is the specific dosage and administration method claimed in U.S. Patent No. 9,925,123?
U.S. Patent No. 9,925,123 claims a method of treating tardive dyskinesia by administering valbenazine ditartrate, with specific daily dosage ranges and titration schedules outlined in various embodiments and examples within the patent.
- Can Lupin launch its generic Ingrezza while the patent litigation is ongoing?
Lupin cannot launch its generic product if it has received a Paragraph IV certification notice and Neurocrine has filed suit within 45 days of that notice, as it triggers a 30-month stay on FDA approval. However, if the litigation concludes before the 30-month period, approval can be granted earlier. Neurocrine’s filing on May 12, 2021, within the 45-day window of Lupin’s Paragraph IV notice, would have triggered such a stay.
- What is the expiration date of U.S. Patent No. 9,925,123?
The statutory expiration date for U.S. Patent No. 9,925,123 is May 30, 2034. This date may be subject to adjustments, such as patent term extension due to FDA regulatory delays.
- Are there other patents protecting Ingrezza that might be challenged in the future?
Yes, Neurocrine holds a portfolio of patents related to valbenazine, its synthesis, formulations, and therapeutic uses. Future litigation could involve these other patents, potentially extending market exclusivity beyond the expiration of the '123 patent.
Citations
[1] Neurocrine Biosciences, Inc. (2024). Neurocrine Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results. Retrieved from [Neurocrine Biosciences Investor Relations website]
