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Last Updated: October 16, 2019

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Claims for Patent: 5,616,560

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Summary for Patent: 5,616,560
Title: Methods for the treatment of osteoporosis using bisphosphonates and parathyroid hormone
Abstract:The present invention provides methods of increasing bone mass in a human or other animal subject afflicted with osteoporosis, comprising a thirty(30)-day treatment period, comprised of a parathyroid hormone administration regimen and a bisphosphonate administration regimen, wherein (a) said parathyroid hormone administration regimen comprises the administration to said subject of parathyroid hormone at one or more level of from about 4 IU/kg per day to about 15 IU/kg per day that said parathyroid hormone is administered, provided that said parathyroid hormone is administered at least one day every seven days of every said thirty(30)-day treatment periods; and wherein (b) said bisphosphonate administration regimen comprises the administration to said subject of a bisphosphonate at a level of from about 0.0005 mgP/kg to about 1.0 mgP/kg per day that said bisphosphonate is administered, provided that said bisphosphonate is administered at least 1 day of every said thirty(30)-day treatment period.
Inventor(s): Geddes; Ann D. (Norwich, NY), Boyce; Rogely W. (Pottstown, PA)
Assignee: The Procter & Gamble Company (Cincinnati, OH)
Application Number:08/619,103
Patent Claims:1. A method of increasing bone mass in a human or other animal subject afflicted with osteoporosis, consisting essentially of a thirty(30)-day treatment period, consisting essentially of a parathyroid hormone administration regimen and bisphosphonate administration regimen, wherein

(a) said parathyroid hormone administration regimen consists essentially of the administration to said subject of parathyroid hormone at a level of from about 4 IU/kg per day to about 15 IU/kg per day that said parathyroid hormone is administered, provided that said parathyroid hormone is administered at least one day every seven days of every said thirty(30)-day treatment period; and wherein

(b) said bisphosphonate administration regimen consists essentially of the administration to said subject of a bisphosphonate at a level of from about 0.0005 mgP/kg to about 1.0 mgP/kg per day that said bisphosphonate is administered, provided that said bisphosphonate is administered at least 1 day of every said thirty(30)-day treatment period.

2. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, before a significant loss of net skeletal mass has occurred in said subject.

3. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bone-active phosphonate is a bisphosphonic acid, or a pharmaceutically-acceptable salt or ester thereof.

4. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bisphosphonic acid is of the formula: ##STR7## wherein: n is an integer from 0 to 7; R.sup.1 is hydrogen, chloro, amino, or hydroxy; X is --NH--, oxygen, or a single bond; R.sup.2 is a 5- to 7-membered herocycle having from 1 to 3 heteroatoms, amino, amino substituted with one or two lower alkyl groups, or hydrogen; and their pharmaceutically-acceptable salts and esters.

5. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bisphosphonic acid is selected from the group consisting of: 1-hydroxyethane-1,1-bisphosphonic acid; dichoromethane bisphosphonic acid; 3-amino-1-hydroxypropane-1,1-bisphosphonic acid; 6-amino-1-hydroxyhexane-1,1-bisphosphonic acid; 4-amino-1-hydroxybutane-1,1-bisphosphonic acid; 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid; 2-(N-imidazoyl)-1-hydroxyethane-1,1-bisphosphonic acid; 3-(N-pentyl-N-methlamino)-1-hydroxyethane-1,1-bisphosphonic acid; 3-(N-pyrollidino)-1-hydroxypropane-1,1-bisphosphonic acid; N-cycloheptylaminomethanebisphosphonic acid; S-(p-chlorophenyl)thiomethanebisphosphonic acid; (7-dihydro-1-pyridine)methanebisphosphonic acid; (7-dihydro-1-pyridine)hydroxymethanebisphosphonic acid; (6-dihydro-2-pyridine)hydroxymethanebisphosphonic acid; 2-(6-pyrolopyridine)-1-hydroxyethane-1,1-bisphosphonic acid; 2-(2-pyridyl)-1-hydroxy-ethane-1,1-bisphosphonic acid; and pharmaceutically-acceptable salts and esters thereof.

6. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 5, wherein said bisphosphonic acid is 1-hydroxyethane-1,1-bisphosphonic acid, or a pharmaceutically acceptable salt or ester thereof.

7. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 5, wherein said bisphosphonic acid is 2-(3-pyridyl)-1-hudroxethane-1,1-bisphosphonic acid, or a pharmaceutically acceptable salt or ester thereof.

8. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bone-active phosphonate is a phosphonoalkylphosphinate, or a pharmaceutically-acceptable salt or ester thereof.

9. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 8, wherein said phosphonoalkylphosphinate is selected from the group consisting of: N-(2'-(3'-methyl)-pyridinyl)aminomethane phosphonomethylphosphinic acid; N-(2'-(5'-methyl)-pyridinyl)aminomethane phosphonomethylphosphinic acid; N-(2'-(3'-methyl)-piperidinylidene)aminomethane phosphonomethylphosphinic acid; N-(2'-(5'-methyl)-piperidinylidene)aminomethane phosphonomethyl phosphinic acid; 2-(2'-pyridinyl)ethane-1-phosphono-1-methylphosphinic acid; 2-(2'-piperidinyl)ethane-1-phosphono-1-methylphosphinic acid; 2-(p-aminophenyl)-1-hydroxy-ethane-1-phosphono-1-methylphosphinic acid; 2-(m-aminophenyl)-1-hydroxy-ethane-1-phosphono-1-methylphosphinic acid; N-(1-(5-amino-2-methyl-1-oxo)-pentyl)aminomethane phosphonomethylphosphinic acid; N-(2'-(3'-methyl)-piperidinylidene)aminomethane phosphonobutylphosphinic acid; S-(2'-pyridinyl)thiomethane phosphonomethylphosphinic acid; and 2-(2-pyridyl)-1-hydroxyethane-1-phosphono-1-methylphosphinic acid; 2-(3-pyridyl)-1-hydroxy ethane-1-phosphono-1-methylphosphinic acid; 2-(N-imidazoyl)-1-hydroxy ethane-1-phosphono-1-methylphosphinic acid; 3-(N-pentyl-N-methylamino)-1-hydroxpropane-1-phosphono-1-methyl phosphinic acid; 4-amino-1-hydroxybutane-1-phosphono-1-methylphosphinic acid; 3-(N-pyrollidino)-1-hydroxypropane-1-phosphono-1-methyl phosphinic acid; N-cycloheptylaminomethanephosphonomethylphosphinic acid; S-(p-chlorophenyl)thiomethanephosphonomethylphosphinic acid; (7-dihydro-1-pyridine)methanephosphonomethylphosphinic acid; (7-dihydro-1-pyridine)hydroxymethanephosphonomethyl phosphinic acid; (6-dihydro-2-pyridine)hydroxymethanephosphonomethylphosphinic acid; 2-(6-pyrolopyridine)-1-hydroxyethane-1-phosphono-1-methylphosphinic acid; and pharmaceutically-acceptable salts and esters thereof.

10. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said parathyroid hormone is selected from the group consisting of h PTH (1-38), h PTH (1-34) and h PTH (1-37).

11. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said parathyroid hormone is administered every day of said thirty(30)-day treatment period.

12. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said parathyroid hormone is administered every other day of said thirty(30)-day treatment period.

13. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said parathyroid hormone is administered every third day of said thirty(30)-day treatment period.

14. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bisphosphonate is administered every other day of said thirty(30)-day treatment period.

15. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bisphosphonate is administered every third day of said thirty(30)-day treatment period.

16. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 1, wherein said bisphosphonate is administered every day of said thirty(30)-day treatment period.

17. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, consisting essentially of one or more thirty(30)-day treatment periods, comprised of a parathyroid hormone administration regimen, wherein said parathyroid hormone is a species of parathyroid hormone having 1-38 amino acid units, and bisphosphonate administration regimen, wherein, said bisphosphonate is 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonate, wherein,

(a) said parathyroid hormone administration regimen comprises the administration to said subject of said parathyroid hormone at a level of from about 4 IU/kg per day to about 15 IU/kg per day that said parathyroid hormone is administered, provided that said parathyroid hormone is administered at least one day every seven days of every said thirty(30)-day treatment period; and wherein

(b) said bisphosphonate administration regimen comprises the administration to said subject of said bisphosphonate at a level of from about 0.0005 mgP/kg to about 1.0 mgP/kg per day that said bisphosphonate is administered, provided that said bisphosphonate is administered at least 1 day of every said thirty(30)-day treatment period.

18. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, before a significant loss of net skeletal mass has occurred in said subject.

19. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, wherein said parathyroid hormone is administered every day of said thirty(30)-day treatment period.

20. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, wherein said parathyroid hormone is administered every other day of said thirty(30)-day treatment period.

21. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, wherein said parathyroid hormone is administered every third day of said thirty(30)-day treatment period.

22. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, wherein said bisphosphonate is administered every other day of said thirty (30)-day treatment period.

23. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, wherein said bisphosphonate is administered every third day of said thirty(30)-day treatment period.

24. A method of increasing bone mass in a human or other mammal subject afflicted with osteoporosis, according to claim 17, wherein said bisphosphonate is administered every day of said thirty(30)-day treatment period.

Details for Patent 5,616,560

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Request a Trial The Procter & Gamble Company (Cincinnati, OH) 2011-12-17 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Request a Trial The Procter & Gamble Company (Cincinnati, OH) 2011-12-17 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Request a Trial The Procter & Gamble Company (Cincinnati, OH) 2011-12-17 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23   Request a Trial The Procter & Gamble Company (Cincinnati, OH) 2011-12-17 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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