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Last Updated: October 22, 2019

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Claims for Patent: 9,125,909

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Summary for Patent: 9,125,909
Title:1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Abstract: This disclosure relates to 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or a pharmaceutically acceptable salt thereof in a crystalline form.
Inventor(s): Bang-Andersen; Benny (Copenhagen S, DK), Faldt; Andre (Vejlebrovej, DK), Mork; Arne (Malov, DK), de Diego; Heidi Lopez (Naerum, DK), Holm; Rene (Jyllinge, DK), Stensbol; Tine Bryan (Vaerlose, DK)
Assignee: H. Lundbeck A/S (Copenhagen-Valby, DK)
Application Number:14/326,725
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,125,909
Patent Claims: 1. A method of treating cognitive impairment involving decline in speed of processing, executive function, attention, or verbal learning and memory in a patient diagnosed with depression, the method comprising administering a therapeutically effective amount of a pharmaceutical composition comprising Compound I or a pharmaceutically acceptable salt thereof to the patient; wherein Compound I is 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine, Compound I or a pharmaceutically acceptable salt thereof is in a crystalline form, and the method alleviates a symptom or complication of the cognitive impairment or delays the progression of the cognitive impairment.

2. The method of claim 1, wherein a pharmaceutically acceptable salt of Compound I is a hydrobromide, hydrochloride, mesylate, fumarate, maleate, meso-tartrate, L-(+)-tartrate, D-(-)-tartrate, sulphate, phosphate or nitrate salt.

3. The method of claim 1, wherein a pharmaceutically acceptable salt of Compound I is 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine hydrobromide salt.

4. The method of claim 1, wherein the pharmaceutical composition is a tablet prepared by wet granulation and comprises anhydrous calcium hydrogen phosphate, corn starch, PVP-VA copolymer, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate.

5. The method of claim 1, wherein the pharmaceutical composition comprises: TABLE-US-00008 HBr salt of Compound I 3-8% Anhydrous calcium 35-45% hydrogen phosphate Corn starch 15-25% PVP-VA copolymer 2-6% Microcrystalline cellulose 20-30% Sodium starch glycolate 1-3% Talc 2-6% Magnesium stearate 0.5-2%.

6. The method of claim 1, wherein the pharmaceutical composition comprises: TABLE-US-00009 HBr salt of Compound I approximately 5% Anhydrous calcium approximately 39% hydrogen phosphate Corn starch approximately 20% PVP-VA copolymer approximately 3% Microcrystalline cellulose approximately 25% Sodium starch glycolate approximately 3% Talc approximately 4% Magnesium stearate approximately 1%.

7. The method of claim 1, wherein the depression is generalized depression.

8. The method of claim 1, wherein the depression is major depressive disorder.

9. The method of claim 1, wherein the depression is postnatal depression.

10. The method of claim 1, wherein the depression is a depression associated with bipolar disorder.

11. The method of claim 1, wherein the depression is a treatment resistant depression.

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