Sertraline hydrochloride form II and methods for the...

Organic compounds -- part of the class 532-570 series – Organic compounds – Amino nitrogen containing

Reexamination Certificate

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Reexamination Certificate

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10861271

ABSTRACT:
The present invention is directed to Form II of sertraline hydrochloride and novel methods for its preparation. According to the present invention, sertraline hydrochloride Form II may be produced directly form sertraline base or sertraline mandelate. It may also be produced from sertraline hydrochloride solvate and hydrate forms, and crystallized from new solvent systems. Pharmaceutical compositions containing sertraline hydrochloride Form II and methods of treatment using such pharmaceutical compositions are also disclosed.

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Willard M. Welch et al. “Nontricyclic Antidepressant Agents Derived from cis-and trans-1-Amino-4-aryltralins”, 1984, Journal of Medicinal Chemistry, vol. 27, No. 11, pp. 1508-1515.
*G.M. Wall, “Pharmaceutical Applications of Drug Crystal Studies”, Pharmaceutical Manufacturing, vol. 3, No. 2, Feb. 1986, pp. 33-42.
*J.K. Haleblian et al., “Pharmaceutical Applications of Polymorphism”, Journal of Pharmaceutical Sciences, vol. 58, No. 8, Aug. 1969, pp. 911-929.
*J.K. Haleblian, “Characterization of Habits and Crystalline Modification of Solids and Their Pharmaceutical Applications”, Journal of Pharmaceutical Sciences, vol. 64, No. 8, Aug 1975, pp. 1269-1288.
*Protest Under C.F.R. §1.291(a) (2003).
*Declaration of Professor Gautam R. Desiraju, Ph.D. (2004).
*The Patents Act, 1970 (39 of 1970), Notice of Opposition to Grant of a Patent(See Section 25; Rule 55) (2004).
*Written Statement of Opposition to Grant of a Patent (Under Rule 57 of the Patents Rules, 2003 to the Patents Act, 1977) (2004).

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