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Details for Patent: RE44159

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Details for Patent: RE44159

Title:Composition for contraception
Abstract: A combination product for oral contraception is disclosed comprising an estrogen selected from 2.0 to 6.0 mg of 17.beta.-estradiol and 0.020 mg of ethinylestradiol; and a gestagen selected from 0.25 to 0.30 mg of drospirenone and 0.1 to 0.2 mg of cyproterone acetate, followed by 5 or 4 pill-free or sugar pill days.
Inventor(s): Spona; Jurgen (Vienna, AT), Dusterberg; Bernd (Berlin, DE), Ludicke; Frank (Basel, CH)
Assignee: Bayer Schering Pharma Aktiengesellschaft (Berlin, DE)
Filing Date:Aug 28, 2007
Application Number:11/892,969
Claims:1. A combination product for oral contraception, comprising (a) 23 or 24 dosage units, each containing an estrogen selected from >2.0 to 6.0 mg of 17.beta.-estradiol and 0.020 mg of ethinylestradiol; and a gestagen selected from 0.25 to 0.30 mg of drospirenone and 0.1 to 0.2 mg of cyproterone acetate, and b) 5 or 4, respectively, active ingredient-free placebo pills or other indications to show that the daily administration of the 23 or 24 dosage units respectively, is to be followed by 5 or 4, respectively pill-free or placebo pill days..].

.[.2. A combination preparation for oral contraception according to claim 1, wherein the estrogen is ethinylestradiol..].

.[.3. A combination preparation of claim 2, wherein the gestagen is cyproterone acetate..].

.[.4. A combination preparation of claim 2, wherein the gestagen is drospirenone..].

.[.5. A combination preparation according to claim 1, wherein the estrogen is present in a dose of 20 .mu.g of ethinylestradiol or an equivalent dose of 17.beta.-estradiol and the gestagen is present in a dose equivalent to 75 .mu.g of gestadene..].

.[.6. A combination preparation according to claim 1, which comprises 23 dosage units and 5 placebo pills or other indications to show that no dosage unit or a placebo pill is administered during the last 5 days of the menstrual cycle..].

.[.7. A combination preparation according to claim 1, which comprises 23 dosage units, each containing 20 .mu.g of ethinylestradiol and a dose of cyproterone acetate or drospirenone equivalent to 75 .mu.g of gestodene and 5 placebo pills or other indications to show that no dosage unit or a placebo pill is administered during the last 5 days of the menstrual cycle..].

.[.8. A combination preparation of claim 1, wherein the estrogen is 17.beta.-estradiol..].

.[.9. A combination preparation of claim 8, wherein the gestagen is cyproterone acetate..].

.[.10. A combination preparation of claim 8, wherein the gestagen is drospirenone..].

.Iadd.11. A method of inducing contraception in a female of reproductive age who has not yet reached premenopause, comprising administering to said female a monophasic composition that effectively lessens premenstrual syndrome, comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.12. A method of claim 11 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg..Iaddend.

.Iadd.13. A method of claim 12 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.14. A method of inducing contraception in a female of reproductive age who has not yet reached premenopause, comprising administering to said female a monophasic composition that effectively lessens breast tenderness, comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition effectively lessens breast tenderness, and is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.15. A method of claim 14 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg..Iaddend.

.Iadd.16. A method of claim 15 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.17. A method of claim 11 wherein the composition effectively lessens breast tenderness..Iaddend.

.Iadd.18. A method of claim 17 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg..Iaddend.

.Iadd.19. A method of claim 18 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.20. A method of inducing contraception in a female of reproductive age suffering from premenstrual syndrome who has not yet reached premenopause, comprising administering to said female a monophasic composition comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.21. A method of claim 20 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg..Iaddend.

.Iadd.22. A method of claim 21 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.23. A method of inducing contraception in a female of reproductive age suffering from breast tenderness who has not yet reached premenopause, comprising administering to said female a monophasic composition comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.24. A method of claim 23 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg..Iaddend.

.Iadd.25. A method of claim 24 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.

.Iadd.26. A method of claim 20 wherein the female of reproductive age suffers from breast tenderness..Iaddend.

.Iadd.27. A method of claim 26 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg..Iaddend.

.Iadd.28. A method of claim 27 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle..Iaddend.
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