Claims for Patent: 10,046,000

Summary for Patent: 10,046,000

Title:	Use of 2-methylene-19-nor-(20S)-1.alpha.,25-Dihydroxyvitamin D.sub.3 to treat and prevent secondary hyperparathyroidism in a subject having renal failure
Abstract:	Disclosed are methods of administering 2-methylene-19-nor-(20S)-1.alpha.,25-dihydroxyvitamin D.sub.3 to treat and/or prevent secondary hyperparathyroidism and/or its accompanying symptoms in a subject having or at risk for developing secondary hyperparathyroidism.
Inventor(s):	DeLuca; Hector F. (Deerfield, WI), Plum; Lori A. (Arena, WI), Zella; Julia B. (Horicon, WI), Clagett-Dame; Margaret (Deerfield, WI)
Assignee:	Wisconsin Alumni Research Foundation (Madison, WI)
Application Number:	15/604,069
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,046,000
Patent Claims:	1. A method for prophylactic treatment of a symptom of secondary hyperparathyroidism (SHPT) comprising administering 2-methylene-19-nor-(20S)-1.alpha.,25-dihydroxyvitamin D.sub.3 (2MD) or a pharmaceutically acceptable salt thereof to a subject having renal failure; wherein the symptom of secondary hyperparathyroidism (SHPT) is selected from the group consisting of elevated serum PTH, elevated serum phosphorus, and elevated serum creatine and the method does not induce hypercalcemia in the subject. 2. The method of claim 1, wherein the therapeutically effective amount ranges from about 1 ng/kg bw to about 10 ng/kg bw. 3. The method of claim 1, wherein the subject is administered a therapeutically effective amount of 2MD three times per week. 4. The method of claim 1, wherein the subject has SHPT, and the 2MD is administered at a therapeutically effective amount for treating the SHPT or symptoms thereof without inducing hypercalcemia in the subject. 5. The method of claim 4, wherein the treated symptoms of SHPT are selected from the group consisting of elevated serum parathyroid hormone (PTH), elevated serum phosphorus, and elevated serum creatinine. 6. The method of claim 1, wherein the 2MD is formulated in an oral, topical, transdermal, parenteral, injection or infusion dosage form. 7. A method for prophylactic treatment of a symptom of secondary hyperparathyroidism (SHPT) comprising administering 2-methylene-19-nor-(20S)-1.alpha.,25-dihydroxyvitamin D.sub.3 (2MD) or a pharmaceutically acceptable salt thereof to a subject having a renal glomerular filtration rate of less than 15 mL/min/1.73 m.sup.2; wherein the symptom of secondary hyperparathyroidism (SHPT) is selected from the group consisting of elevated serum PTH, elevated serum phosphorus, and elevated serum creatine and the method does not induce hypercalcemia in the subject. 8. The method of claim 7, wherein the therapeutically effective amount ranges from about 1 ng/kg bw to about 10 ng/kg bw. 9. The method of claim 7, wherein the subject is administered a therapeutically effective amount of 2MD three times per week. 10. The method of claim 7, wherein the subject has SHPT, and the 2MD is administered at a therapeutically effective amount for treating the SHPT or symptoms thereof without inducing hypercalcemia in the subject. 11. The method of claim 10, wherein the treated symptoms of SHPT are selected from the group consisting of elevated serum parathyroid hormone (PTH), elevated serum phosphorus, and elevated serum creatinine. 12. The method of claim 7, wherein the 2MD is formulated in an oral, topical, transdermal, parenteral, injection or infusion dosage form. 13. A method for prophylactic treatment of a symptom of secondary hyperparathyroidism (SHPT) comprising administering 2-methylene-19-nor-(20S)-1.alpha.,25-dihydroxyvitamin D.sub.3 (2MD) or a pharmaceutically acceptable salt thereof to a subject receiving hemodialysis treatment; wherein the symptom of secondary hyperparathyroidism (SHPT) is selected from the group consisting of elevated serum PTH, elevated serum phosphorus, and elevated serum creatine and the method does not induce hypercalcemia in the subject. 14. The method of claim 13, wherein the therapeutically effective amount ranges from about 1 ng/kg bw to about 10 ng/kg bw. 15. The method of claim 13, wherein the subject is administered a therapeutically effective amount of 2MD three times per week. 16. The method of claim 13, wherein the subject has SHPT, and the 2MD is administered at a therapeutically effective amount for treating the SHPT or symptoms thereof without inducing hypercalcemia in the subject. 17. The method of claim 16, wherein the treated symptoms of SHPT are selected from the group consisting of elevated serum parathyroid hormone (PTH), elevated serum phosphorus, and elevated serum creatinine.

Details for Patent 10,046,000

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2032-06-29