Barr Pharma announced that the U.S. District Court of Delaware has delivered favorable ruling in the challenge of innovator Ortho McNeil Janssen's Orange Book listed patent w.r.t Razadyne(Galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets
US4663318 (Expiry: Dec 14, 2008): Which covers method of treating Alzheimer's disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of Galanthamine or a pharmaceutically-acceptable acid addition salt thereof.
The Court's decision will effectively end the 30-month stay with respect to Barr's generic Razadyne tablets and Barr's generic Razadyne ER (Galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules. USFDA has given final approval to Barr’s ANDA on August 28, 2008, as per USFDA records (Orange Book).
The '318 patent was found to be invalid for lack of enablement. The Judge also denied Janssen's request for a Temporary Restraining Order, which would have prevented Barr from marketing its product.
The other patents listed for this product in Orange Book are as follows, which were not in litigation:
US6099863 (Expiry: Jun 6, 2017): which covers a tablet comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, wherein said carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and an insoluble or poorly soluble cross-linked polymer disintegrant.
US6358527 (Expiry: Jun 6, 2017): which covers a method of treating a disorder selected from dementia, mania or nicotine dependence in a patient in need thereof comprising administering to the patient a tablet comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, wherein said carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and an insoluble or poorly soluble cross-linked polymer disintegrant.
Barr filed an Abbreviated New Drug Application (ANDA) with the USFDA for Janssen's Razadyne (Galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets on February 28, 2005. On June 15, 2005, Barr announced that Janssen had filed suit in the District Court for the District of Delaware, and the trial occurred in May 2007.
Barr also has a pending ANDA for Razadyne ER (Galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules. In its ANDA for that product, Barr certified that the '318 patent was invalid, unenforceable or not infringed. Barr subsequently amended its application to certify that an additional following Orange Book patent,
US7160559 (Expiry: Dec 20, 2019): which covers controlled release formulation containing galantamine as the active ingredient, characterized in that it comprises particles comprising galantamine hydrobromide (1:1), and a water soluble film forming polymer wherein the galantamine hydrobromide (1:1) and the water soluble film forming polymer are layered or coated on inert spheres, said particles being coated by a release rate controlling membrane coating wherein the release rate controlling membrane coating comprises a water insoluble polymer and optionally a plasticizer, and wherein the formulation further comprises a topcoat comprising galantamine and water-soluble polymer and wherein the formulation is capable of releasing in USP buffer pH 6.8 at 37.degree. C. in a paddle apparatus operating at 50 rpm, from 20 to 40% of the total amount of galantamine.HBr in 1 hour, and more than 80% of the total amount of galantamine.HBr in 10 hours.
The ‘559 patent was not listed at the time Barr's original ANDA was filed, was invalid, unenforceable or not infringed. Innovator Janssen sued Barr in the District Court of New Jersey on June 30, 2006. Pursuant to an Order in the case, Judge's decision in the District of Delaware will be given effect in the Razadyne ER litigation. Barr believes that, because the '559 patent was not listed at the time Barr's original application was filed, the decision with respect to the '318 patent will end the 30-month stay with respect to the generic Razadyne ER product.
Barr also announced that it would launch the product immediately in the US market with 180 days exclusivity. The other generic players would be able to market their product after the expiry of Barr’s 180 days exclusivity, from March 1 , 2009 onwards.
The other generic players who filed Para IV against Immidiate Release tablets are Sandoz, Par Pharmaceutical, Alphapharm, Purepac, Dr. Reddy's, Mylan and Teva
The other generic players who filed Para IV against Extended Release capsules are KV pharma and Sandoz
Razadyne tablets had annual sales of approximately $102 million for the twelve months ending June 2008, according to IMS sales data.
Razadyne ER capsules had annual sales of approximately $112 million for the twelve months ending June 2008, according to IMS sales data.
Also, innovator announced that it would challenge the district court’s decision in higher court
US4663318 (Expiry: Dec 14, 2008): Which covers method of treating Alzheimer's disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of Galanthamine or a pharmaceutically-acceptable acid addition salt thereof.
The Court's decision will effectively end the 30-month stay with respect to Barr's generic Razadyne tablets and Barr's generic Razadyne ER (Galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules. USFDA has given final approval to Barr’s ANDA on August 28, 2008, as per USFDA records (Orange Book).
The '318 patent was found to be invalid for lack of enablement. The Judge also denied Janssen's request for a Temporary Restraining Order, which would have prevented Barr from marketing its product.
The other patents listed for this product in Orange Book are as follows, which were not in litigation:
US6099863 (Expiry: Jun 6, 2017): which covers a tablet comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, wherein said carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and an insoluble or poorly soluble cross-linked polymer disintegrant.
US6358527 (Expiry: Jun 6, 2017): which covers a method of treating a disorder selected from dementia, mania or nicotine dependence in a patient in need thereof comprising administering to the patient a tablet comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, wherein said carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and an insoluble or poorly soluble cross-linked polymer disintegrant.
Barr filed an Abbreviated New Drug Application (ANDA) with the USFDA for Janssen's Razadyne (Galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets on February 28, 2005. On June 15, 2005, Barr announced that Janssen had filed suit in the District Court for the District of Delaware, and the trial occurred in May 2007.
Barr also has a pending ANDA for Razadyne ER (Galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules. In its ANDA for that product, Barr certified that the '318 patent was invalid, unenforceable or not infringed. Barr subsequently amended its application to certify that an additional following Orange Book patent,
US7160559 (Expiry: Dec 20, 2019): which covers controlled release formulation containing galantamine as the active ingredient, characterized in that it comprises particles comprising galantamine hydrobromide (1:1), and a water soluble film forming polymer wherein the galantamine hydrobromide (1:1) and the water soluble film forming polymer are layered or coated on inert spheres, said particles being coated by a release rate controlling membrane coating wherein the release rate controlling membrane coating comprises a water insoluble polymer and optionally a plasticizer, and wherein the formulation further comprises a topcoat comprising galantamine and water-soluble polymer and wherein the formulation is capable of releasing in USP buffer pH 6.8 at 37.degree. C. in a paddle apparatus operating at 50 rpm, from 20 to 40% of the total amount of galantamine.HBr in 1 hour, and more than 80% of the total amount of galantamine.HBr in 10 hours.
The ‘559 patent was not listed at the time Barr's original ANDA was filed, was invalid, unenforceable or not infringed. Innovator Janssen sued Barr in the District Court of New Jersey on June 30, 2006. Pursuant to an Order in the case, Judge's decision in the District of Delaware will be given effect in the Razadyne ER litigation. Barr believes that, because the '559 patent was not listed at the time Barr's original application was filed, the decision with respect to the '318 patent will end the 30-month stay with respect to the generic Razadyne ER product.
Barr also announced that it would launch the product immediately in the US market with 180 days exclusivity. The other generic players would be able to market their product after the expiry of Barr’s 180 days exclusivity, from March 1 , 2009 onwards.
The other generic players who filed Para IV against Immidiate Release tablets are Sandoz, Par Pharmaceutical, Alphapharm, Purepac, Dr. Reddy's, Mylan and Teva
The other generic players who filed Para IV against Extended Release capsules are KV pharma and Sandoz
Razadyne tablets had annual sales of approximately $102 million for the twelve months ending June 2008, according to IMS sales data.
Razadyne ER capsules had annual sales of approximately $112 million for the twelve months ending June 2008, according to IMS sales data.
Also, innovator announced that it would challenge the district court’s decision in higher court
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