Barr Invalidates Galantamine Method of Use patent: Planning for an “AT RISK” launch
CNN Money reported
Barr says court voids Alzheimer's drug patent
Barr says Delaware court overturns patent on Johnson & Johnson's Razadyne ER
August 28, 2008: 11:56 AM EST
NEW YORK (Associated Press) - Barr Pharmaceuticals Inc. said Thursday a U.S. District Court voided a patent on the drug Razadyne, a drug used to treat dementia related to Alzheimer's disease, which would allow Barr to sell a generic version.
Barr said Judge Sue Robinson of the U.S. District Court for the District of Delaware sided with Barr. The company said Robinson cited a lack of enablement, or a description of how to make and use Razadyne and Razadyne ER, in ruling that the patent is not valid.
Barr said it is considering its options and plans to launch the generic as soon as it receives final approval from the Food and Drug Administration. The company is preparing to sell the drug before its patents expire, in what is known as an "at-risk" launch.
Robinson also denied a request from Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson, to issue a restraining order to prevent Barr from selling the drug. Ortho-McNeil said it will appeal the ruling.
According to Barr, sales of Razadyne extended-release capsules reached $112 million in the 12 months ended June 2008, while total sales of Razadyne tablets were $102 million.
Patent 4,664,318 concerns the 8 milligram, 16 milligram and 24 milligram extended release capsules of Razadyne, also called galantamine hydrobromide. Razadyne ER was scheduled to lose patent protection in December.
CNN Money reported
Barr says court voids Alzheimer's drug patent
Barr says Delaware court overturns patent on Johnson & Johnson's Razadyne ER
August 28, 2008: 11:56 AM EST
NEW YORK (Associated Press) - Barr Pharmaceuticals Inc. said Thursday a U.S. District Court voided a patent on the drug Razadyne, a drug used to treat dementia related to Alzheimer's disease, which would allow Barr to sell a generic version.
Barr said Judge Sue Robinson of the U.S. District Court for the District of Delaware sided with Barr. The company said Robinson cited a lack of enablement, or a description of how to make and use Razadyne and Razadyne ER, in ruling that the patent is not valid.
Barr said it is considering its options and plans to launch the generic as soon as it receives final approval from the Food and Drug Administration. The company is preparing to sell the drug before its patents expire, in what is known as an "at-risk" launch.
Robinson also denied a request from Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson, to issue a restraining order to prevent Barr from selling the drug. Ortho-McNeil said it will appeal the ruling.
According to Barr, sales of Razadyne extended-release capsules reached $112 million in the 12 months ended June 2008, while total sales of Razadyne tablets were $102 million.
Patent 4,664,318 concerns the 8 milligram, 16 milligram and 24 milligram extended release capsules of Razadyne, also called galantamine hydrobromide. Razadyne ER was scheduled to lose patent protection in December.
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