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Claims for Patent: 7,858,605

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Claims for Patent: 7,858,605

Title:Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Abstract:This invention relates to a method of preventing pregnancy and treating PMS including PMDD. More particularly, the invention relates to a method, which involves administering one of several combination oral contraceptive regimens in combination with an antidepressant and a kit containing the same.
Inventor(s): Bell; Robert G. (Palm Harbor, FL), Ben-Maimon; Carole (Merion, PA), Iskold; Beata (Livingston, NJ)
Assignee: Teva Women's Health, Inc. (Woodcliff Lake, NJ)
Application Number:11/951,492
Patent Claims: 1. A preparation comprising (a) 81 to 89 dosage forms comprising a combination of estrogen and progestin; and (b) 2 to 8 dosage forms consisting essentially of estrogen, wherein: the estrogen in each of the 81 to 89 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 10 .mu.g to about 50 .mu.g of ethinyl estradiol; the estrogen in each of the 2 to 8 dosage forms consisting essentially of estrogen in (b) is present in an amount equivalent to about 5 .mu.g to about 10 .mu.g ethinyl estradiol; and the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel.

2. The preparation of claim 1, wherein the estrogen in the each of the 81 to 89 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 10 .mu.g to about 30 .mu.g of ethinyl estradiol.

3. The preparation of claim 1, wherein the estrogen in each of the 81 to 89 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 30 .mu.g of ethinyl estradiol.

4. The preparation of claim 1, wherein the estrogen in each of the 2 to 8 dosage forms consisting essentially of estrogen in (b) is present in an amount equivalent to about 10 .mu.g ethinyl estradiol.

5. The preparation of claim 1, wherein the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 150 .mu.g of levonorgestrel.

6. The preparation of claim 1, wherein the preparation comprises 84 dosage forms in (a).

7. The preparation of claim 1, wherein the preparation comprises 5-8 dosage forms in (b).

8. The preparation of claim 1, wherein the preparation comprises 7 dosage forms in (b).

9. The preparation of claim 1, wherein the preparation comprises 84 dosage forms in (a) and 7 dosage forms in (b).

10. The preparation of claim 1, wherein the estrogen is ethinyl estradiol.

11. The preparation of claim 1, wherein the preparation further comprises an antidepressant.

12. The preparation of claim 11, wherein the antidepressant is present in combination with the 2 to 8 dosage forms consisting essentially of estrogen.

13. The preparation of claim 11, wherein the antidepressant is present in combination with 5 to 8 dosage forms consisting essentially of estrogen.

14. The preparation of claim 11, wherein the antidepressant is present in an amount equivalent to about 5 mg to about 120 mg of fluoxetine hydrochloride.

15. The preparation of claim 11, wherein the antidepressant is present in combination with one dosage form of the 2 to 8 dosage forms consisting essentially of estrogen.

16. The preparation of claim 11, wherein the antidepressant is fluoxetine hydrochloride.

17. The preparation of claim 1, wherein the dosage forms are tablets for oral administration.

18. The preparation of claim 1, wherein the dosage forms are transdermal dosage forms for transdermal administration.

19. The preparation of claim 1, wherein the dosage forms are for monophasic administration.

20. A preparation comprising (a) 84 dosage forms comprising a combination of estrogen and progestin; and (b) 7 dosage forms consisting essentially of estrogen, wherein: the estrogen in each of the 84 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 10 .mu.g to about 30 .mu.g of ethinyl estradiol; the estrogen in each of the 7 dosage forms consisting essentially of estrogen in (b) is present in an amount of about 10 .mu.g ethinyl estradiol; the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel; and wherein the dosage forms in (a) and (b) are tablets for oral administration.

21. A preparation comprising (a) 84 dosage forms comprising a combination of estrogen and progestin; and (b) 7 dosage forms consisting essentially of estrogen, wherein: the estrogen in each of the 84 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 30 .mu.g of ethinyl estradiol; the estrogen in each of the 7 dosage forms consisting essentially of estrogen in (b) is present in an amount of about 10 .mu.g ethinyl estradiol; the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 150 .mu.g of levonorgestrel; and wherein the dosage forms in (a) and (b) are tablets for oral administration.

22. A preparation comprising (a) 81 to 89 dosage forms comprising a combination of estrogen and progestin; and (b) 2 to 8 dosage forms comprising estrogen without progestin, wherein: the estrogen in each of the 81 to 89 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 10 .mu.g to about 30 .mu.g of ethinyl estradiol; the estrogen in each of the 2 to 8 dosage forms comprising estrogen without progestin in (b) is present in an amount equivalent to about 5 .mu.g to about 10 .mu.g ethinyl estradiol; and the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel.

23. The preparation of claim 22, wherein the dosage comprising estrogen without progestin in (b) is a dosage consisting of estrogen and one or more pharmaceutically acceptable excipients.

24. A preparation comprising (a) 81 to 89 dosage forms comprising a combination of estrogen and progestin; and (b) 2 to 8 dosage forms comprising estrogen without progestin, wherein: the estrogen in each of the 81 to 89 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 30 .mu.g of ethinyl estradiol; the estrogen in each of the 2 to 8 dosage forms comprising estrogen without progestin in (b) is present in an amount equivalent to about 10 .mu.g ethinyl estradiol; and the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 150 .mu.g of levonorgestrel.

25. The preparation of claim 24, wherein the dosage comprising estrogen without progestin in (b) is a dosage consisting of estrogen and one or more pharmaceutically acceptable excipients.

26. A preparation comprising (a) 84 dosage forms comprising a combination of estrogen and progestin; and (b) 7 dosage forms comprising estrogen without progestin, wherein: the estrogen in each of the 84 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 10 .mu.g to about 30 .mu.g of ethinyl estradiol; the estrogen in each of the 7 dosage forms comprising estrogen without progestin in (b) is present in an amount equivalent to about 5 .mu.g to about 10 .mu.g ethinyl estradiol; and the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel.

27. The preparation of claim 26, wherein the dosage comprising estrogen without progestin in (b) is a dosage consisting of estrogen and one or more pharmaceutically acceptable excipients.

28. A preparation comprising (a) 84 dosage forms comprising a combination of estrogen and progestin; and (b) 7 dosage forms comprising estrogen without progestin, wherein: the estrogen in each of the 84 dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount equivalent to about 30 .mu.g of ethinyl estradiol; the estrogen in each of the 7 dosage forms comprising estrogen without progestin in (b) is present in an amount equivalent to about 10 .mu.g ethinyl estradiol; and the progestin in each of the dosage forms comprising the combination of estrogen and progestin in (a) is present in an amount of about 150 .mu.g of levonorgestrel.

29. The preparation of claim 28, wherein the dosage comprising estrogen without progestin in (b) is a dosage consisting of estrogen and one or more pharmaceutically acceptable excipients.

30. A kit comprising the preparation of claim 1, wherein the dosage forms are arranged in a fixed sequence that corresponds to the stages of daily administration.
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