New Crystalline Forms of Des-Methyl-Venlafaxine Salt Discovered
PolyCrystalLine s.r.l. and Segrub Pharmaceuticals have developed a generic equivalent to Pristiq (desvenlafaxine succinate). This DEP001 product is expected to enter the US market at least three years before any other generic desvenlafaxine products enter the market. Pristiq sales are projected to exceed one billion dollars yearly.
Pristiq was approved in 2008 by Wyeth Pharmaceuticals for the treatment of major depression in the US, Brazil and Australia. Clinical trials are underway for market entry in China and Japan. Wyeth is also conducting:
- Phase 3 trials for the use of Pristiq to treat the vasomotor symptoms of menopause
- Phase 2 trials for the use of Pristiq to treat fibromyalgia
The DEP001 product contains a new pharmaceutically acceptable salt of desvenlafaxine which circumvents all of Wyeth’s IP relating to Pristiq. DEP001 is expected to be bioequivalent to Pristiq. There are no other known salts of desvenlafaxine which are pharmaceutically acceptable and suitable to make a bioequivalent product to Pristiq.
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