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Last Updated: April 26, 2024

Claims for Patent: 9,216,206

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Summary for Patent: 9,216,206

Title:	Methods of treating symptoms associated with menopause and hormonal variations with G-CSF
Abstract:	The invention provides for compositions and methods of treating or ameliorating menopausal symptoms and/or symptoms associated with hormonal variations by administering granulocyte colony-stimulating factor (G-CSF). The invention also provides for compositions and methods of treating or ameliorating arthritis using G-CSF.
Inventor(s):	Duke; Debra M. (Denver, CO), Duke; Richard C. (Denver, CO)
Assignee:	MenoGeniX, Inc. (Aurora, CO)
Application Number:	13/055,368
Patent Claims:	1. A method of treating a symptom caused by naturally occurring or surgically-induced menopause in an individual in need thereof, comprising: administering to the individual an effective amount of granulocyte colony stimulating factor (G-CSF). 2. The method according to claim 1, wherein the treatment reduces the frequency of hot flashes. 3. The method according to claim 1, wherein G-CSF is administered at a dose of about 5 mcg/kg bodyweight. 4. The method according to claim 1, wherein G-CSF is administered at a dose of about 2-20 mcg/kg bodyweight. 5. The method according to claim 1, wherein G-CSF is administered once every about one to two months. 6. The method according to claim 1, wherein G-CSF is administered once every about two to three months. 7. The method according to claim 1, wherein G-CSF is administered once every about three to four months. 8. The method according to claim 1, wherein G-CSF is administered subcutaneously or intravenously. 9. The method according to claim 1, wherein G-CSF is administered parenterally, enterically, topically or via inhalation. 10. The method according to claim 1, wherein G-CSF is formulated in the commercially available composition Filgrastim, Pegfilgrastim or Lenograstim. 11. The method according to claim 1, wherein G-CSF is present in a pharmaceutical composition comprising G-CSF and a pharmaceutically-acceptable carrier. 12. The method of claim 1, wherein the individual is additionally suffering from osteoarthritis. 13. The method of claim 1 wherein the symptom comprises one or more of hot flashes; night sweats; headache; migraines; dizziness; sleep disorders; fatigue; formication; nausea; emesis; palpitations; pain including joint pain; loss of bone density (osteoporosis); myalgia; mood swings; forgetfulness; general malaise; changes in serum lipid levels; changes in urination; weight gain and shift; skin, hair and eye changes; dryness of the eyes, mouth, nose and vagina; pain with intercourse; and decreased libido. 14. The method of claim 1, wherein the symptom comprises one or more of hot flashes; fatigue; sleep disorders; night sweats; joint pain; forgetfulness; and mood swings. 15. The method of claim 1 wherein the individual is either undergoing menopause or is postmenopausal. 16. A method of alleviating discomfort or pain associated with a menopausal symptom caused by naturally occurring or surgically-induced menopause in an individual in need thereof comprising: administering to the individual an effective amount of granulocyte colony-stimulating factor (G-CSF). 17. The method of claim 16, wherein the pain is a joint pain. 18. The method of claim 16 wherein the symptom comprises one or more of hot flashes; night sweats; headache; migraines; dizziness; sleep disorders; fatigue; formication; nausea; emesis; palpitations; pain including joint pain; loss of bone density (osteoporosis); myalgia; mood swings; forgetfulness; general malaise; changes in serum lipid levels; changes in urination; weight gain and shift; skin, hair and eye changes; dryness of the eyes, mouth, nose and vagina; pain with intercourse; and decreased libido. 19. The method of claim 16, wherein the symptom comprises one or more of hot flashes; fatigue; sleep disorders; night sweats; joint pain; forgetfulness; and mood swings. 20. The method of claim 16 wherein the individual is either undergoing menopause or is postmenopausal.

Details for Patent 9,216,206

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991	⤷ Try a Trial	2028-07-22
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000	⤷ Try a Trial	2028-07-22
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031	01/31/2002	⤷ Try a Trial	2028-07-22
Amgen, Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	12/23/2014	⤷ Try a Trial	2028-07-22
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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