Alchemia of
Australia has launched generic fondaparinux sodium for injection in the US
through its marketing partner Dr Reddy’s Laboratories.
The launch follows the approval by the US Food and Drug Administration of the Abbreviated New Drug Application (ANDA) receivedin last month. The launch covers 2.5mg/0.5 ml, 5.0mg/0.4 ml, 7.5mg/0.6 ml and 10.0mg–/0.8 ml doses of the drug in prefilled color-coded, single-dose syringes with an automatic needle safety device.
Fondaparinux is extremely difficult to manufacture at scale. Alchemia’s improved process for the manufacture of fondaparinux, licensed to Dr Reddy's, is covered by two issued, and two pending patents in the US.
Dr Reddy’s has a substantial and rapidly growing generics business in the US and will be responsible for the marketing of generic fondaparinux.
Given the significant scale of barriers to entry for other competitors, it is likely that Alchemia’s generic fondaparinux will face limited competition in the foreseeable future.
The launch follows the approval by the US Food and Drug Administration of the Abbreviated New Drug Application (ANDA) receivedin last month. The launch covers 2.5mg/0.5 ml, 5.0mg/0.4 ml, 7.5mg/0.6 ml and 10.0mg–/0.8 ml doses of the drug in prefilled color-coded, single-dose syringes with an automatic needle safety device.
Fondaparinux is extremely difficult to manufacture at scale. Alchemia’s improved process for the manufacture of fondaparinux, licensed to Dr Reddy's, is covered by two issued, and two pending patents in the US.
Dr Reddy’s has a substantial and rapidly growing generics business in the US and will be responsible for the marketing of generic fondaparinux.
Given the significant scale of barriers to entry for other competitors, it is likely that Alchemia’s generic fondaparinux will face limited competition in the foreseeable future.
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