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Allergan, Adamas Agree to Settle Namzaric Patent Litigation
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Allergan plc announced that its subsidiaries and Adamas Pharmaceuticals, Inc. have entered into a settlement agreement with privately held U.S. generic drug maker, Amneal Pharmaceuticals to resolve the patent infringement litigation related to Namzaric.
Amneal was looking for an approval of its abbreviated new drug application (ANDA) for the generic versions of Namzaric extended-release (XR), a once-daily, fixed-dose combination of Namenda XR (memantine hydrochloride; a NMDA receptor antagonist) and Aricept (donepezil hydrochloride; an acetylcholinesterase inhibitor). Namzaric is approved for the treatment of moderate-to-severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil HCl once daily.
While Namenda XR is approved for the treatment of moderate-to-severe dementia of the Alzheimer's type, Aricept is approved for the treatment of mild-to-severe dementia of the Alzheimer's type.
Allergan believes that Amneal is the first applicant to file an ANDA containing a paragraph IV certification for Namzaric.
As per the terms of the settlement, which are first subject to a review by the Federal Trade Commission, Amneal can start selling its generic versions of Namzaric on Jan 1, 2025, upon a final approval from the FDA. Alternatively, under certain circumstances, Amneal can choose to launch an authorized generic version of Namzaric on Jan 1, 2026. However, other terms of the settlement were undisclosed.
We note that Allergan has settled patent infringement lawsuits related to Namzaric with a couple of other companies as well.
However, Allergan’s patent infringement litigation against Amerigen Pharmaceuticals, Inc. and Amerigen Pharmaceuticals Ltd., both of whom had filed an ANDA for their generic versions of Namzaric, remains pending in the U.S. District Court for the District of Delaware.
Allergan collaborated with Adamas for the development of the fixed-dose combination. While Allergan has commercialization rights in the U.S., Adamas holds the rights in the ex-U.S. markets.
We note that Namzaric was launched in the second quarter of 2015. In the first half of 2016, the drug recorded sales of $23.1 million. Namzaric’s launch has helped offset the impact of a decline in Namenda immediate release/IR sales. Allergan started facing generic competition for Namenda IR from Jul 2015.
Namzaric received approval for a label expansion in the U.S. in Jul 2016. With an expanded indication, patients with moderate-to-severe Alzheimer's disease, who are currently stabilized on Aricept, can now start combination therapy directly with Namzaric. The label expansion should boost the drug’s sales significantly.
Additionally, Allergan is focused on the development of a number of new compounds for the treatment of Alzheimer's disease, including first-in-class selective small molecule agonists targeting muscarinic M1 and M4 receptors in the brain.
Allergan currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. (ANIK - Free Report) and Geron Corporation (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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Allergan, Adamas Agree to Settle Namzaric Patent Litigation
Allergan plc announced that its subsidiaries and Adamas Pharmaceuticals, Inc. have entered into a settlement agreement with privately held U.S. generic drug maker, Amneal Pharmaceuticals to resolve the patent infringement litigation related to Namzaric.
Amneal was looking for an approval of its abbreviated new drug application (ANDA) for the generic versions of Namzaric extended-release (XR), a once-daily, fixed-dose combination of Namenda XR (memantine hydrochloride; a NMDA receptor antagonist) and Aricept (donepezil hydrochloride; an acetylcholinesterase inhibitor). Namzaric is approved for the treatment of moderate-to-severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil HCl once daily.
While Namenda XR is approved for the treatment of moderate-to-severe dementia of the Alzheimer's type, Aricept is approved for the treatment of mild-to-severe dementia of the Alzheimer's type.
Allergan believes that Amneal is the first applicant to file an ANDA containing a paragraph IV certification for Namzaric.
As per the terms of the settlement, which are first subject to a review by the Federal Trade Commission, Amneal can start selling its generic versions of Namzaric on Jan 1, 2025, upon a final approval from the FDA. Alternatively, under certain circumstances, Amneal can choose to launch an authorized generic version of Namzaric on Jan 1, 2026. However, other terms of the settlement were undisclosed.
We note that Allergan has settled patent infringement lawsuits related to Namzaric with a couple of other companies as well.
However, Allergan’s patent infringement litigation against Amerigen Pharmaceuticals, Inc. and Amerigen Pharmaceuticals Ltd., both of whom had filed an ANDA for their generic versions of Namzaric, remains pending in the U.S. District Court for the District of Delaware.
Allergan collaborated with Adamas for the development of the fixed-dose combination. While Allergan has commercialization rights in the U.S., Adamas holds the rights in the ex-U.S. markets.
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We note that Namzaric was launched in the second quarter of 2015. In the first half of 2016, the drug recorded sales of $23.1 million. Namzaric’s launch has helped offset the impact of a decline in Namenda immediate release/IR sales. Allergan started facing generic competition for Namenda IR from Jul 2015.
Namzaric received approval for a label expansion in the U.S. in Jul 2016. With an expanded indication, patients with moderate-to-severe Alzheimer's disease, who are currently stabilized on Aricept, can now start combination therapy directly with Namzaric. The label expansion should boost the drug’s sales significantly.
Additionally, Allergan is focused on the development of a number of new compounds for the treatment of Alzheimer's disease, including first-in-class selective small molecule agonists targeting muscarinic M1 and M4 receptors in the brain.
Allergan currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. (ANIK - Free Report) and Geron Corporation (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>