Dive Brief:
- Depomed won a patent fight over its opioid pain killer drug Nucynta (apentadol) when a federal judge in New Jersey ruled in the company’s favor against three generics.
- Judge U.S. District Court Judge Clare C. Cecchi allowed Depomed, which is based in Newark, CA, to maintain the franchise for its major drug over the next 9 years.
- Filing the unsuccessful patent infringement claim were Actavis, Alkem Laboratories and Roxane Laboratories, which had filed abbreviated new drug applications for the Nucynta drugs.
Dive Insight:
Depomed may be breathing yet another a sigh of relief following some improved financial footing in a swirl of ups and downs over Nucynta, amidst an upcoming board of directors challenge. Last year, Depomed bought Nucynta from Johnson & Johnson’s Janssen Pharmaceuticals for $1.05 billion to expand its opioid market.
With the judge’s ruling, the company said it expects to protect the Nucynta franchise, which includes the oral solution and an extended-release version, until December 2025. In effect, the ruling prevents Actavis (now Allergan), Alkem Laboratories and Roxane Laboratories from selling generic versions of Nucynta until then, Depomed said in a statement.
In her ruling, the judge found the Depomed patents to be "valid and infringed” by the defendants. Nucynta, an extended-release formula, is marketed for short-term use to treat moderate to severe pain, while Nucynta Er is for long-term use. An oral solution of Nucynta is not yet marketed.
"We are pleased with the court’s decision as it confirms the validity and strength of the Nucynta patents," said Jim Schoenek, president and CEO of Depomed. "We look forward to growing the Nucynta franchise, comprised of two important and highly-differentiated medicines, for at least the next 9 years."
The patent for Nucynta ER would be covered until March 2029. The judge found two of three challengers did not infringe on the patent. Depomed said it would appeal that part of the ruling.
All three defendants filed ANDAs for Nucynta ER and Nucynta. An affiliate of Actavis filed an ANDA for Nucynta oral solution.
The company reported a second quarter report of $274 million in sales of Nucynta, an increase over 59% over the final year of sales under Janssen —the drug only brought in about $114 million during 2014. Nucynta has been getting a lot more attention now that it is being marketed by the small biotech; the drug was largely ignored under the umbrella of the multi-national conglomerate.
But Depomed's problems aren't over; activist investor Starboard Value asked for a special meeting of the board of directors to be held Nov 15, seeking a shakeup of the board, suggesting that the company is under-valued, according to various media reports. Depomed spent the bulk of 2015 fending off a hostile takeover from Horizon pharma. The specialty pharma company began its pursuit for Depomed after it lost the bid to buy Nucynta from J&J.