Impax announces settlement of contract litigation on Opana ER CII Extended-Release tablets
Contract dispute relates to an agreement entered into among Endo International, Penwest Pharmaceuticals and Impax.
Impax Laboratories has announced a Settlement Agreement to resolve a contract dispute relating to an agreement entered into in June 2010 among Endo International, Penwest Pharmaceuticals and Impax regarding the Abbreviated New Drug Application (ANDA) litigation related to the original formulation of Opana ER (oxymorphone hydrochloride) CII Extended-Release (ER) tablets. In the 2010 ANDA Settlement, Impax obtained a non-exclusive license to certain then-existing and future Endo patents. Orange Book listed patents for Opana ER extend until November 2029.
The Contract Settlement Agreement includes an amendment to the 2010 ANDA Settlement, whereby Impax agrees to pay Endo a royalty rate that splits Impax's gross profits for its sales of oxymorphone hydrochloride CII ER products, commencing 1 January 2018. The royalty will be eliminated based on certain commercial conditions. Further terms of the settlement were not disclosed.
"We are pleased to have reached an agreement to settle this outstanding contractual litigation," said Paul Bisaro, President and Chief Executive Officer of Impax. "We will continue to make available our generic version of original Opana ER (oxymorphone hydrochloride) CII ER tablets for prescribing physicians that prefer this product to treat patients."
Combined reported net sales of Endo's new formulation of Opana ER and Impax's generic oxymorphone hydrochloride ER tablets (AB-rated to original formulation of Opana ER) were $229 million for the last 12 months ended 31 March 2017.
Related News
-
News Pharmaceutical Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain.
-
News Merck KGaA to buy US biotech SpringWorks for US$3.9 billion
The German multinational pharmaceutical company Merck KGaA have signed a deal to buy US biotech company SpringWorks Therapeutics at an equity value of US$3.9 billion in a move to add rare cancer therapeutics to their pipelines.
-
News Cassava Sciences halts Alzheimer's drug trial after limited progress
Cassava Sciences have drawn a close to their investigations and development of the drug simufilam, which they intended to be used for the treatment of Alzheimer’s disease.
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.
-
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries.
-
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.