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ALKERMES, INC. v. TEVA PHARMACEUTICALS, INC. Patents

Case Filing Date: 2025-08-15

Patent NumberOrganic/AcquiredForward Citation CountAge Of Patent From Priority DateIndependent Claim CountClaim 1 Word CountFamily SizePatent Quality Score
US11707466Organic04 years, 9 months4171748
US11951111Organic04 years, 9 months4250739
Patent SummaryIndependent Claim
US11707466 - Immediate Release Multilayer Tablet

A pharmaceutically acceptable coated bilayer tablet delivers fixed doses of olanzapine and samidorphan for oral administration. The tablet's unique bilayer structure ensures precise dosage and rapid release of active ingredients. This innovation enhances treatment efficacy for disorders like schizophrenia and bipolar I disorder.
1. A pharmaceutically acceptable coated immediate release bilayer tablet for orally delivering a fixed dose of olanzapine and 10 mg of samidorphan, wherein the bilayer tablet comprises:
 a first tablet layer comprising:
 10 mg samidorphan or a pharmaceutically acceptable salt of samidorphan in an amount to deliver 10 mg samidorphan;
 about 35-43 wt % microcrystalline cellulose, based on the weight of the first tablet layer;
 about 37-43 wt % lactose or a hydrate thereof, based on the weight of the first tablet layer;
 and about 1.5 to about 2 wt % magnesium stearate;
 a second tablet layer comprising:
 a dose of olanzapine selected from the group consisting of 5 mg, 10 mg, 15 mg and 20 mg of the olanzapine;
 about 38-42 wt % microcrystalline cellulose, based on the weight of the second tablet layer;
 about 46-49 wt % lactose or a hydrate thereof, based on the weight of the second tablet layer;
 and about 1.0 wt % magnesium stearate;
 and a film coating over the first and second tablet layer.
US11951111 - Immediate Release Multilayer Tablet

A method for treating schizophrenia or bipolar I disorder involves administering a bilayer tablet with precisely formulated layers of olanzapine and samidorphan. The tablet's rapid release properties ensure effective delivery of active ingredients. This approach improves patient outcomes through enhanced drug bioavailability.
1. A method of treating schizophrenia or bipolar I disorder in a patient in need thereof, the method comprising orally administering to the patient, once daily, a pharmaceutically acceptable coated immediate release bilayer tablet for orally delivering a fixed dose of olanzapine and 10 mg of samidorphan, wherein the bilayer tablet comprises:
 a first tablet layer comprising:
 10 mg samidorphan or a pharmaceutically acceptable salt of samidorphan in an amount to deliver 10 mg samidorphan;
 about 35-43 wt % microcrystalline cellulose, based on the weight of the first tablet layer;
 about 37-43 wt % lactose or a hydrate thereof, based on the weight of the first tablet layer;
 and about 1.5 to about 2 wt % magnesium stearate;
 a second tablet layer comprising:
 a dose of olanzapine selected from the group consisting of 5 mg, 10 mg, 15 mg and 20 mg of the olanzapine;
 about 38-42 wt % microcrystalline cellulose, based on the weight of the second tablet layer;
 about 46-49 wt % lactose or a hydrate thereof, based on the weight of the second tablet layer;
 and about 1.0 wt % magnesium stearate;
 and a film coating over the first and second tablet layer, wherein the tablet releases at least 97% of olanzapine and at least 97% of the samidorphan after 30 minutes when the tablet is tested in 500 mL USP acetate buffer at pH 1.0 using a USP Apparatus II (Paddle Method) at 37 with a paddle speed of 75 rpm and using a three-prong sinker.

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