Claims for Patent: 7,615,545

Summary for Patent: 7,615,545

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:	Duramed Pharmaceuticals, Inc. (Pomona, NY)
Application Number:	11/892,014
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,615,545
Patent Claims:	1. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 81 to 89 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 2 to 8 consecutive days, wherein the estrogen that is administered in combination with progestin for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 10 .mu.g to about 50 .mu.g of ethinyl estradiol, the estrogen that is administered for the period of 2 to 8 consecutive days is administered in a daily amount equivalent to about 5 .mu.g to about 10 .mu.g of ethinyl estradiol, and the progestin that is administered for the period of 81 to 89 consecutive days is administered in a daily amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel. 2. The method of claim 1, wherein the estrogen that is administered for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 10 .mu.g to about 30 .mu.g of ethinyl estradiol. 3. The method of claim 1, wherein the estrogen that is administered for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 30 .mu.g of ethinyl estradiol. 4. The method of claim 1, wherein the estrogen that is administered for the period of 2 to 8 consecutive days is administered in a daily amount equivalent to about 10 .mu.g of ethinyl estradiol. 5. The method of claim 1, wherein the dosage comprising the combination of estrogen and progestin is administered for at least 84 consecutive days. 6. The method of claim 1, wherein the dosage consisting essentially of estrogen is administered for a period of 5 to 8 consecutive days. 7. The method of claim 6, wherein the dosage consisting essentially of estrogen is administered for at least 7 consecutive days. 8. The method of claim 1, wherein the dosage comprising the combination of estrogen and progestin is administered for 84 consecutive days, and the dosage consisting essentially of estrogen is administered for 7 consecutive days. 9. The method of claim 1, wherein the estrogen is ethinyl estradiol. 10. The method of claim 1, wherein an antidepressant is administered (i) in combination with the dosage consisting essentially of estrogen for the period of 2 to 8 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly. 11. The method of claim 10, wherein the combination of the dosage consisting essentially of estrogen and the antidepressant that is administered for the period of 2 to 8 consecutive days is administered for a period of 5 to 8 consecutive days. 12. The method of claim 11, wherein the antidepressant administered in combination with the estrogen for the period of 5 to 8 consecutive days is administered in a daily amount equivalent to about 5 mg to about 120 mg of fluoxetine hydrochloride. 13. The method of claim 10, wherein a one-time dose of the antidepressant is administered in combination with the dosage consisting essentially of estrogen. 14. The method of claim 10, wherein the antidepressant is fluoxetine hydrochloride. 15. The method of claim 1, wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 81 to 89 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 8 consecutive days, are administered orally. 16. The method of claim 1, wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 81 to 89 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 8 consecutive days, are administered transdermally. 17. The method of claim 1, wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 81 to 89 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 8 consecutive days, are administered monophasicly. 18. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days, wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g to about 50 .mu.g of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel. 19. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days, wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g to about 30 .mu.g of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel. 20. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage comprising estrogen without progestin for a period of 7 consecutive days, wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g to about 30 .mu.g of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 50 .mu.g to about 150 .mu.g of levonorgestrel. 21. The method of claim 20, wherein the dosage comprising estrogen without progestin for the period of 7 consecutive days is a dosage consisting of estrogen and one or more pharmaceutically acceptable excipients. 22. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage comprising estrogen without progestin for a period of 7 consecutive days, wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 30 .mu.g of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 .mu.g of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 150 .mu.g of levonorgestrel. 23. The method of claim 22, wherein the dosage comprising estrogen without progestin for the period of 7 consecutive days is a dosage consisting of estrogen and one or more pharmaceutically acceptable excipients. 24. The method of claim 22, wherein the dosage comprising estrogen without progestin for the period of 7 consecutive days is a dosage consisting essentially of estrogen.