Galantamine (Razadyne, 4, 8 and 12 mg/tablet): Innovator sued Sandoz for filing Para IV

Innovator ORTHO MCNEIL JANSSEN has sued Sandoz in Delaware District Court, after the generics maker filed an ANDA for Galantamine (Razadyne, 4, 8 and 12 mg/tablet), which is indicated to treat Alzheimer's disease. This drug was approved by USFDA on Feb 28, 2001.
Following are the orange Book listed patents on this product
US4663318 (Expiry: Dec 14, 2008)- which covers a 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
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.
Other generic players in litigation:
Teva
Mylan
Dr. Reddy's
Barr
Alpharma
Purepac
Par