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PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. has released the Generess Fe birth control pill in the United States and begun shipping an authorized generic version of the attention deficit hyperactivity disorder (ADHD) drug Concerta.
The company said Monday that Generess Fe 0.8 mg/25 mcg (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is a low-dose oral contraceptive that’s "highly effective" at preventing pregnancy and provides women with short, lighter and predictable periods.
Generess Fe has a once-daily 24/4 dosing regimen, according to Watson. The company noted that extending the duration of the active combined oral contraceptive treatment from 21 to 24 days and decreasing the drug-free interval to four days has been proven to decrease overall bleeding, especially withdrawal bleeding. In clinical trials, women taking Generess Fe experienced shorter periods that decreased in length over time. Also, for many women taking the pill, periods were more predictable, with withdrawal bleeding typically beginning on day 27 and the incidence of breakthrough bleeding decreasiing over time.
As part of the Generess Fe launch, Watson has created the "I am Generess" patient support program. The company said the effort caps participant cost for the oral contraceptive at $25 per prescription, and it’s donating $5 in the patient’s name to their choice of certain women’s charities, including the Rape, Abuse & Incest National Network (RAINN), the National Coalition Against Domestic Violence (NCADV) and the Society for Women’s Health Research (SWHR).
Also on Monday, the pharmaceutical maker said its Watson Laboratories Inc. subsidiary has started rolling out an authorized generic of Concerta (methylphenidate hydrochloride extended-release tablets) as part of an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals Inc.
Under the pact, Watson said, Ortho-McNeil-Janssen manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson markets and distributes the product in the United States.
The agreement runs until the end of 2014. Watson said that during the term of the agreement, it may continue to pursue Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and may launch its own ANDA product at the end of the exclusive supply pact.
Concerta is approved for the treatment of ADHD in children ages 6 to 17 and in adults 18 to 65. For the 12 months ended Feb. 28, Concerta had sales of about $1.5 billion, according to IMS Health figures reported by Watson.
