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Summary Description of Patent
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ITI-007
Product Patent (approved drug product—lumateperone tosylate—in any pharmaceutical form)
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March 12, 2028 (US: does not include expected
6-month
extension in US for pediatric studies)
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ITI-007
Crystal Form Patent (approved drug product—lumateperone tosylate—in solid crystalline form)
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US (8,648,077*; 9,199,995*; 9,586,960*), EP (AT, BE, BG, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, NL, NO, PL, PT, RO, SE, SI, SK, TR), AU, CA, CN, KR, HK, JP and MX
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December 1, 2029 (US; does not include expected
6-month
extension for pediatric studies; additional patent term extension possible through 2033**);
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Pending in IL, IN
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ITI-007
Dosage and Method of Treatment Patents (including schizophrenia, bipolar depression, sleep disorder indications)
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US (8,598,119*; 9,616,061*), AU, CA, CN, JP, MX
Pending: US (continuation), (divisional), EP, IN, KR, MX (divisional)
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December 28, 2029 (US; does not include expected
6-month
extension for pediatric studies; additional patent term extension possible through 2033**);
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ITI-007
Residual Symptoms Patent (treatment of negative/residual symptoms of schizophrenia)
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US (9,956,227*), AU, JP, RU
Pending: US (continuation), AU (divisional), JP (divisional), EP (allowed), IN, KR, MX, CA, BR IL, CN
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December 3, 2034 (US and
ex-US;
does not include expected US
6-month
extension for pediatric studies;)
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Patents for Additional Dosage Forms
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Pending: US (continuation), AU, CA, CN, EP, IN, IL, JP, KR, MX, RU
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2037-2039
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