Allergan Notes Receipt of Paragraph IV Notification on Restasis
Allergan has confirmed that the company has received a notice letter dated 10 July 2015 (the "Notice Letter") from Akorn Pharmaceuticals stating that the FDA has received Akorn's Abbreviated New Drug Application (ANDA) containing a "Paragraph IV" patent certification seeking approval to market a generic version of Allergan's Restasis (cyclosporine ophthalmic emulsion) 0.05% product. In addition, Allergan has received communication suggesting that additional ANDAs for generic versions of Restasis may have been received by the FDA.
The Notice Letter received from Akorn states that the "Paragraph IV" patent certification was made with respect to certain US patents covering the formulation and method of use of the Restasis product, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Allergan has five Orange Book-listed patents covering Restasis that are scheduled to expire in August 2024.
Allergan is highly confident in its intellectual property rights relating to Restasis and intends to vigorously enforce such rights in all applicable venues.
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.