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Kariva

Oral contraceptives come in a variety of formulations. The main division is between combined oral contraceptive pills, containing both estrogen and progesterone, and progesterone only pills (mini-pills). Combined oral contraceptive pills also come in varying types, including varying doses of estrogen, and whether the dose of estrogen or progesterone changes from week to week. more...

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Combined oral contraceptive pills

All contain the estrogen ethinyl estradiol, although in varying amounts, and one of a number of different progesterones. They are taken for 21 days with then a 7 day gap during which a withdrawal bleed (often, but incorrectly, referred to as a menstrual period) occurs. These differ in the amount of estrogen given, and whether they are monophasic (only one dose of estrogen and progesterone during the 21 days) or multiphasic (varying doses).

Monophasic

These are given as 21 tablets of estrogen and progesterone, followed by 7 tablets of placebo. Different formulations contain different amounts of estrogen and progesterone:

  • 20 mcg estrogen
    • 0.1 mg levonorgestrel (Alesse®, Levline®)
    • 1 mg norethindrone acetate (Loestrin 1/20®Fe)
  • 30 mcg estrogen
    • 0.15 mg levonorgestrel (Levlen®, Levora®, Nordette®)
    • 0.3 mg norgestrel (Lo-Ovral®)
    • 0.15 mg desogestrel (Desogen®, Organon; Ortho-Cept®, Ortho-McNeil)
    • 1.5 mg norethindrone acetate (Loestrin® 1.5/30)
    • 3.0 mg drospirenone (Yasmin®)
  • 35 mcg estrogen
    • 0.25 mg norgestimate (Ortho-Cyclen®)
    • 0.4 mg norethindrone (Ovcon-35®, Warner Chilcott)
    • 0.5 mg norethindrone (Modicon®, Brevicon®)
    • 1 mg norethindrone (Ortho-Novum 1/35®, Necon®, Norethin®, Norinyl 1/35®)
    • 1 mg ethynodiol diacetate (Demulen 1/35®, Zovia 1/35E®)
  • 50 mcg estrogen
    • 0.4 mg norethindrone (Ovcon-50®, Warner Chilcott))
    • 1 mg norethindrone (Necon 1/50®, Norinyl 1/50®, Ortho-Novum 1/50®, Ovcon-50®)
    • 0.5 mg norgestrel (Ovral®)
    • 1 mg ethynodiol diacetate (Demulen 1/50®, Zovia 1/50E®)

Multiphasic

  • Desogestrel 0.15 mg and ethinyl estradiol 0.02 mg x 14 tablets, followed by ethynil estradiol 0.01 mg x 2 tablets, followed by 5 tablets of placebo (Kariva®, Barr Laboratories; Mircette®, Organon)
  • Desogestrel 0.1 mg ethynil estradiol 0.025 mg x 7 tablets, followed by desogestrel 0.125 mg and ethynil estradiol 0.025 mg x 7 tablets, followed by desogestrel 0.15 mg and ethynil estradiol 0.025 mg x 7 tablets, followed by 7 tablets of ferric oxide (Cyclessa®, Organon; Velivet®, Barr Laboratories)
  • Norethindrone 0.5 mg and ethinyl estradiol 0.035 mg x 7 tablets, followed by 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol x 7 tablets, followed by 1 mg of norethindrone and 0.035 of ethinyl estradiol, followed by 7 tablets of placebo (Ortho-Novum 7/7/7®)
  • Norethindrone 0.5 mg and 0.035 mg of ethinyl estradiol x 10 tablets, followed by 1 mg norethindrone and 0.035 ethinyl estradiol x 11 tablets, followed by 7 tablets of placebo (Ortho-Novum 10/11®)

Read more at Wikipedia.org


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Savient Pharmaceuticals Finalizes Agreement for the Settlement of Mircette® Litigation; Transaction Terminates Patent Litigation and Results in $13.75
From Business Wire, 12/2/05

EAST BRUNSWICK, N.J. -- Savient Pharmaceuticals, Inc. ("Savient") (NASDAQ: SVNTE), an emerging specialty pharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that address unmet medical needs in niche and broader markets, announced today that it has concluded with Barr Pharmaceuticals, Inc. ("Barr") (NYSE: BRL), Organon USA Inc. and Organon (Ireland) Ltd. ("Organon"), business units of Akzo Nobel NV (Nasdaq: AKZOY), an agreement for the settlement of the ongoing patent litigation regarding Barr's generic version of Mircette(R), which Barr markets under the trade name Kariva(R). Under the terms of the transaction Barr will acquire the exclusive rights to Organon's Mircette (Desogestrel/Ethinyl Estradiol) oral contraceptive product.

Under the terms of the transaction, in settlement of the patent litigation and as prepaid future royalties on sales in the United States of Mircette and Kariva, Barr paid Savient $13.75 million, which yields Savient approximately $10.9 million, net of pass-through revenue sharing to the inventor from whom Savient acquired the patents covering Mircette.

Mircette is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mircette is available in a 28-tablet regimen that represents a combination of desogestrel/ethinyl estradiol and ethinyl estradiol.

About Savient Pharmaceuticals, Inc.

Based in East Brunswick, New Jersey, Savient Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to developing, manufacturing and marketing novel therapeutic products that address unmet medical needs. The Company's lead product development candidate, Puricase(R), for the treatment of refractory gout has reported positive Phase 1 and 2 clinical data. Savient's experienced management team is committed to advancing its pipeline and expanding its product portfolio by in-licensing late stage compounds and exploring co-promotion and co-development opportunities that fit the Company's expertise in specialty pharmaceuticals and initial focus in rheumatology. The Company's operations also include a wholly-owned U.K. subsidiary, Rosemont Pharmaceuticals Ltd., which develops, manufactures and markets liquid formulations of prescription pharmaceutical products. Rosemont's product portfolio includes over 90 liquid formulations primarily targeting the geriatric population. Further information on the Company can be accessed by visiting www.savientpharma.com.

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COPYRIGHT 2005 Gale Group

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