Monday, April 1, 2013

Sandoz launches generic equivalents of Ortho Cyclen and Ortho Tri-Cyclen

Sandoz today announced the US Food and Drug Administration (FDA) approvals and US launches of Estarylla™ (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla™ (norgestimate and ethinyl estradiol tablets), generic equivalents of the oral contraceptives Ortho Cyclen® and Ortho Tri-Cyclen®.

According to IMS Health, US sales for branded and generic versions of Ortho Cyclen® and Ortho Tri- Cyclen® were approximately USD 116 million and USD 240 million, respectively, for the 12 months ending in January 2013. Sandoz is marketing Estarylla and Tri-Estarylla in dosage regimens identical to those of the originator brands

Estarylla and Tri-Estarylla are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Additionally, Tri-Estarylla is indicated for the treatment of moderate acne in women at least 15 years of age who additionally desire an oral contraceptive for birth control. Among women in the US who practice contraception (approximately 62% of women aged 15 to 44), 28% choose oral contraceptives, making them the single most commonly used form of contraception.
Other generic players marketing generic copies of  norgestimate and ethinyl estradiol tablets include Watson, Lupin, Vintage, Novast, Teva and Glenmark

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