Claims for Patent: 10,370,350

Summary for Patent: 10,370,350

Title:	Alpha-TEA salt forms: compositions and uses for treating disease
Abstract:	The present disclosure relates to salts of the compound (I), polymorphic forms thereof, methods for preparation and use thereof, and pharmaceutical compositions thereof. ##STR00001##
Inventor(s):	O\'Neill; Michael (Concord, OH), Kidon; Barbara (N/A), Adkins; Thomas (Concord, OH), Wu; Hongqiao (Concord, OH), Akporiaye; Emmanuel T. (Portland, OR)
Assignee:	Research Development Foundation (Carson City, NV)
Application Number:	14/916,271
Patent Claims:	1. A compound of the formula: ##STR00019## wherein X.sub.1.sup.+ is: ##STR00020## or a hydrate thereof. 2. The compound of either claim 1, wherein the X.sub.1.sup.+ is: ##STR00021## or a hydrate, thereof. 3. The compound of claim 1, wherein the X.sub.1.sup.+ is ##STR00022## or a hydrate, thereof. 4. The compound of claim 1, wherein the formula is further defined as: ##STR00023## or a hydrate, thereof. 5. The compound of claim 4, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuK.alpha. comprising two peaks at about 11.84.degree. 2.theta. and 19.74.degree. 2.theta. or a hydrate, thereof. 6. The compound of claim 5, wherein the polymorphic form has an X-ray powder diffraction pattern CuK.alpha. further comprising 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or all of the peaks at about 6.24, 9.35, 14.92, 15.51, 17.03, 18.49, 20.73, 21.70, 22.81, 23.51, 24.85, 27.69, 28.31, 30.93, 32.30, 33.21, 35.02, and 39.30.degree. 2.theta.. 7. The compound of claim 1, wherein the formula is further defined as: ##STR00024## or a hydrate, thereof. 8. The compound of claim 7, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuK.alpha. comprising a peak at about 9.69.degree. 2.theta. or a hydrate, thereof. 9. The compound of claim 8, wherein the X-ray powder diffraction pattern CuK.alpha. further comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or all of the peaks at about 5.90, 7.77, 14.08, 17.58, 17.91, 18.31, 19.78, 20.10, 21.26, 22.17, 23.16, 24.77, 28.57, 29.71, 31.10, 31.69, 34.45, 34.99, and 36.24.degree. 2.theta.. 10. The compound of claim 1, wherein the formula is further defined as: ##STR00025## or a hydrate, thereof. 11. The compound of claim 10, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuK.alpha. comprising a peak at about 20.14.degree. 2.theta. or a hydrate, thereof. 12. The compound of claim 11, wherein the X-ray powder diffraction pattern CuK.alpha. further comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or all of peaks at about 9.67, 15.60, 21.47, 23.57, 27.07, 28.39, 30.49, 32.21, 33.30, 34.29, 34.96, 35.89, and 36.39.degree. 2.theta.. 13. The compound of claim 1, wherein the formula is further defined as: ##STR00026## or a hydrate, thereof. 14. The compound of claim 13, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuK.alpha. comprising a peak at about 19.4, 18.40 and 19.77, or 21.73.degree. 2.theta. or a hydrate, thereof. 15. A pharmaceutical composition comprising a compound, a salt, or a polymorphic form of claim 1 and an excipient. 16. The pharmaceutical composition of claim 15, wherein the pharmaceutical composition is formulated for oral, intraarterial, intravenous, intraperitoneal, topical, or inhalational administration. 17. A method of treating a breast cancer, comprising administering to the patient a therapeutically effective amount of the compound, salt, polymorphic form, or pharmaceutical composition of claim 1. 18. The method of claim 17, further comprising administering to the patient a second therapy. 19. The method of claim 18, wherein the second therapy is an immunotherapy, radiotherapy, chemotherapeutic agent, or surgery. 20. The method of claim 19, wherein the immunotherapy comprises administering a pharmaceutically effective amount of adoptively transferred T lymphocytes, an immune modulating antibody, or a therapeutic antibody. 21. The method of claim 19, wherein the chemotherapeutic agent is an anthracycline, taxane, methotrexate, mitoxantrone, estramustine, doxorubicin, etoposide, vinblastine, carboplatin, vinorelbine, 5-fluorouracil, cisplatin, topotecan, ifosfamide, cyclophosphamide, epirubicin, gemcitabine, vinorelbine, irinotecan, etoposide, vinblastine, pemetrexed, melphalan, capecitabine, oxaliplatin, BRAF inhibitors, or TGF-beta inhibitor. 22. The method of claim 20, wherein the immunotherapy comprises administering a pharmaceutically effective amount of trastuzumab.

Details for Patent 10,370,350

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2033-09-06
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2033-09-06
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2033-09-06