IP Library › Patent Application 12339329
Patent Application
App. No. 12/339,329

Dosage Regimens and Pharmaceutical Compositions and Packages for Emergency Contraception

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Quick Facts
Patent No.
US None
App. No.
12/339,329
Abstract

The present invention is directed to dosage regimens for emergency contraception using nonsteroidal progestins and pharmaceutical compositions and packages thereof. Such regimens are useful for females in need of emergency contraception.

Claims (45)

1 . A method for emergency contraception, comprising administering to a female in need thereof a dosage comprising a nonsteroidal progestin equivalent to about 0.5 mg to about 20 mg of tanaproget, wherein the dosage is effective for emergency contraception.

2 . The method of claim 1 , wherein the nonsteroidal progestin is administered within about 72 hours postcoitus.

3 . The method of claim 1 , wherein the nonsteroidal progestin is administered orally.

4 . The method of claim 1 , wherein the nonsteroidal progestin is tanaproget.

5 . The method of claim 4 , wherein the tanaproget is in an amount of about 1 mg to about 20 mg.

6 . The method of claim 4 , wherein the tanaproget is an amount of about 3 mg to about 10 mg.

7 . The method of claim 1 , wherein the dosage further comprises an estrogen equivalent to about 0.025 mg to about 0.4 mg of ethinyl estradiol.

8 . The method of claim 7 , wherein the estrogen is ethinyl estradiol.

9 . The method of claim 1 , further comprising administering a second dosage comprising a nonsteroidal progestin equivalent to about 0.5 mg to about 10 mg of tanaproget to the female in need thereof.

10 . The method of claim 9 , wherein the second dosage is administered within about 36 hours after administration of a first dosage.

11 . The method of claim 9 , wherein the second dosage is administered within about 12 hours after administration of a first dosage.

12 . The method of claim 9 , wherein the nonsteroidal progestin is tanaproget.

13 . The method of claim 12 , wherein the tanaproget in a first and the second dosages is in an amount of about 0.5 mg to about 10 mg.

14 . The method of claim 12 , wherein the tanaproget in a first and the second dosages is in an amount of about 1.5 mg to about 5 mg.

15 . The method of claim 9 , wherein a first or the second dosage further comprises an estrogen equivalent to about 0.025 mg to about 0.4 mg of ethinyl estradiol.

16 . The method of claim 15 , wherein the estrogen is ethinyl estradiol.

17 . A method for emergency contraception, comprising administering within about 96 hours postcoitus to a female in need thereof a pharmaceutically effective amount of a nonsteroidal progestin for emergency contraception.

18 . The method of claim 17 , wherein the nonsteroidal progestin is administered within about 72 hours postcoitus.

19 . The method of claim 17 , wherein the nonsteroidal progestin is administered within about 48 hours postcoitus.

20 . The method of claim 17 , wherein the nonsteroidal progestin is administered within about 24 hours postcoitus.

21 . The method of claim 17 , wherein the nonsteroidal progestin is administered orally.

22 . The method of claim 17 , wherein the nonsteroidal progestin is tanaproget.

23 . The method of claim 17 , further comprising administering a pharmaceutically effective amount of an estrogen substantially concurrent with the nonsteroidal progestin.

24 . The method of claim 23 , wherein the estrogen is ethinyl estradiol.

25 . (canceled)

26 . (canceled)

27 . A pharmaceutical package for emergency contraception, the package comprising:

(a) a dosage comprising a nonsteroidal progestin in a pharmaceutically effective amount for emergency contraception;

(b) a suitable container; and

(c) a label directing administering the nonsteroidal progestin to a female in need thereof within about 96 hours postcoitus.

28 . The package of claim 27 , wherein the nonsteroidal progestin is tanaproget.

29 . The package of claim 28 , wherein the tanaproget is in an amount of about 1 mg to about 20 mg.

30 . The package of claim 28 , wherein the tanaproget is in an amount of about 3 mg to about 10 mg.

31 . The package of claim 27 , wherein the dosage is in a form of a capsule or a tablet.

32 . The package of claim 27 , wherein the label directs administering the nonsteroidal progestin within about 72 hours postcoitus to the female in need thereof.

33 . The package of claim 27 , comprising two dosages comprising a nonsteroidal progestin.

34 . The package of claim 27 , further comprising a dosage comprising an estrogen equivalent to about 0.025 mg to about 0.4 mg of ethinyl estradiol.

35 . The package of claim 34 , wherein the estrogen is ethinyl estradiol.

36 . A pharmaceutical composition comprising a nonsteroidal progestin in a pharmaceutically effective amount for emergency contraception.

37 . The composition of claim 36 , wherein the nonsteroidal progestin is tanaproget.

38 . The composition of claim 37 , wherein the tanaproget is in an amount of about 1 mg to about 20 mg.

39 . The composition of claim 37 , wherein the tanaproget is in an amount of about 3 mg to about 10 mg.

40 . The composition of claim 37 , wherein the composition is in a form of a capsule or a tablet.

41 . The composition of claim 37 , further comprising an estrogen equivalent to about 0.025 mg to about 0.4 mg of ethinyl estradiol.

42 . The composition of claim 41 , wherein the estrogen is ethinyl estradiol.

Assignments (2)
CHANGE OF NAME Recorded May 19, 2010
From: DURAMED PHARMACEUTICALS, INC.
To: TEVA WOMEN'S HEALTH, INC.
Reel/Frame 024402/0984 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 9, 2009
From: DILIBERTI, CHARLES E.
To: DURAMED PHARMACEUTICALS, INC.
Reel/Frame 022367/0659 →