aibioCollegium settles Grünenthal patent suit over Nucynta ER generic for $17,000,000
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The drugmaker ends its Nucynta license and royalties with Grünenthal and gets certain patents assigned to it. Grünenthal has filed a motion to dismiss the New Jersey case.
Key facts
- Company
- Collegium Pharmaceutical, Inc. (NASDAQ: COLL)
- News type
- Legal
- Primary source
- Collegium Pharmaceutical 8-K, Oct 19, 2026 (SEC EDGAR)
Collegium Pharmaceutical, Inc. (Nasdaq: COLL) said in an 8-K filed Oct 19 that it has settled a patent infringement lawsuit brought by Grünenthal GmbH and has ended a license that required royalty payments on its Nucynta products. The only defendant the 8-K names is Collegium itself. Grünenthal filed the complaint in February 2026 in the United States District Court for the District of New Jersey, and the filing gives no case number.
The complaint concerned the launch of an authorized generic for Nucynta ER. The 8-K calls the case the Nucynta Litigation.
The settlement terms
On October 15, 2026, Collegium and Grünenthal entered into a settlement agreement to resolve all disputes and claims between them, including the Nucynta Litigation. Under the agreement, the two companies agreed to terminate the Grünenthal License in its entirety. They also agreed to end the Consent Agreement, but only for the Territory, a term defined in that agreement that the 8-K does not spell out.
The termination took effect on October 15, after Collegium paid Grünenthal $17,000,000. The 8-K says all of Collegium's royalty obligations under the license have been fully and finally discharged and that no further royalties will be due. It does not say how much Collegium paid in royalties in earlier years, or how the $17,000,000 will be accounted for.
Grünenthal also assigned certain patents related to the Nucynta products to Collegium. The 8-K does not identify those patents by number, expiry date or scope. Grünenthal has also filed a motion to dismiss the Nucynta Litigation, and the 8-K does not say whether the court has ruled on that motion.
The license and the Nucynta products
The license is dated January 13, 2015. Collegium assumed it through a Consent Agreement dated January 30, 2020, among Collegium, Grünenthal and Assertio Therapeutics, Inc. The 8-K ties that assumption to Collegium's 2020 acquisition of Nucynta ER and Nucynta IR. The annual report filed Feb 26, 2026 says the Nucynta products are oral formulations of tapentadol, a Schedule II opioid, and that the FDA approved both forms in November 2008.
Generic competition was already under way before the settlement. The annual report says that in January 2026 the FDA approved a generic equivalent of Nucynta IR under an abbreviated new drug application filed by a third party. It says Hikma Pharmaceuticals USA Inc. launched a generic version of Nucynta IR on February 25, 2026, and that Hikma was expected to launch a generic Nucynta ER in the first quarter of 2026. Collegium had granted Hikma rights to an authorized generic of the Nucynta products. The annual report does not link Hikma to the Grünenthal complaint, and the 8-K does not name Hikma.
The annual report also gives the exclusivity dates. The FDA granted pediatric exclusivity to the Nucynta products in June 2024, which runs to January 3, 2027 for Nucynta IR. For Nucynta ER the same grant ran to December 27, 2025.
The rest of the portfolio
Collegium lists six products it sells in the United States: Jornay PM, Belbuca, Xtampza ER, Nucynta ER, Nucynta IR and Symproic. It acquired Ironshore on September 3, 2024, which had developed Jornay PM, a methylphenidate stimulant for ADHD approved in August 2018.
Xtampza ER is an abuse-deterrent oxycodone formulation. The company says abuse and diversion data for the product have remained low compared with commonly abused Schedule II opioid analgesics. The same passage says methods to defeat its tamper resistance have been reported.
Against the $17,000,000 payment, the annual report shows revenue of $780.6 million in 2025 and $631.4 million in 2024, with net income of $62.9 million against $69.2 million. Cash provided by operations was $329.3 million in 2025. Cash and cash equivalents were $129.5 million at June 30, 2026, with no short-term investments, compared with $231.3 million at the end of 2025.
What comes next
The settlement is already effective, so the open item is the motion to dismiss, which the 8-K does not date. The nearest exclusivity date in the annual report is January 3, 2027, for Nucynta IR. The annual report says the third-party generic approved in January 2026 carves out pediatric use from its label.