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Last Updated: April 25, 2024

Claims for Patent: 9,193,757

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Summary for Patent: 9,193,757

Title:	Onapristone polymorphic forms and methods of use
Abstract:	Polymorphic forms of onapristone and methods of making and using such polymorphic forms are provided. Crystalline polymorphic forms can be characterized by their X-ray powder diffraction patterns and other properties.
Inventor(s):	Proniuk; Stefan (Weehawken, NJ)
Assignee:	ARNO THERAPEUTICS, INC. (Flemington, NJ)
Application Number:	14/203,814
Patent Claims:	1. An onapristone crystalline Form A that exhibits an x-ray powder diffraction pattern (XRPD) having characteristic peaks expressed in degrees 2-theta at approximately 21.22, 12.82, 14.34, 16.14, 18.58, 18.18, 16.78, 11.66, 24.02, and 9.74 with a peak tolerance of +/- 0.2 degrees 2-theta. 2. A pharmaceutical composition comprising the onapristone crystalline Form A of claim 1 and a pharmaceutically acceptable excipient, diluent, or carrier. 3. The pharmaceutical composition of claim 2, in a unit dosage form. 4. The pharmaceutical composition of claim 3, wherein the unit dosage form is selected from the group consisting of tablets, pills, capsules, and troches. 5. The pharmaceutical composition of claim 2, where the onapristone crystalline form is present in an amount from about 10 to about 200 mg. 6. The pharmaceutical composition of claim 2, further comprising at least one additional active pharmaceutical agent. 7. The pharmaceutical composition of claim 6, wherein the additional active pharmaceutical agent is selected from the group consisting of an antitumor agent, a hormone, a steroid, or a retinoid. 8. The pharmaceutical composition of claim 7, wherein the additional active ingredient is selected from the group consisting of everolimus, trastuzumab, TM1-D, anti-HER2 drugs, bevacizumab, paclitaxel, docetaxel, taxanes, doxorubicin, liposomal doxorubicin, pegylated liposomal doxorubicin, anthracyclines, anthracenediones, carboplatin, cisplatin, 5-FU, gemcitabine and cyclophosphamide.

Details for Patent 9,193,757

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998	⤷ Try a Trial	2033-03-12
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017	⤷ Try a Trial	2033-03-12
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004	⤷ Try a Trial	2033-03-12
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019	⤷ Try a Trial	2033-03-12
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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