New generic OCs now on the pharmacy shelves
Generic equivalents of three oral contraceptives (OCs), including the therapeutic equivalent of a popular 20-mcg pill, are now available on pharmacy shelves.
Duramed Pharmaceuticals of Cincinnati began shipment of its Aviane-28 Tablets in May follow-
ing the approval of its Abbreviated New Drug Application by the Food and Drug Administration (FDA), according to Jeff Zurcher, director of corporate communications. With 20 mcg of
ethinyl estradiol and 100 mcg of the progestin levonorgestrel, Aviane is the first generic product deemed bioequivalent to and therapeutically interchangeable with the OC Alesse, which is marketed by Wyeth-Ayerst Laboratories of Philadelphia, according to Duramed.
Barr Laboratories of Pomona, NY, was set to begin distribution at the end of June of its generic equivalent versions of Ortho-Novum 1/35 and Modicon-28, two pills from Raritan, NJ-based Ortho-McNeil Pharmaceuticals, reports Carol Cox, Barr Laboratories spokesman. The company plans to market both strengths as branded generics using the Nortrel trademark, launching Nortrel 1/35 in a 21-day regimen and a 28-day regimen, and Nortrel 0.5/35 in a 28-day regimen.
Look at low-dose option
The addition of Aviane adds another 20-mcg ethinyl estradiol pill to the available options for U.S. women. These alternatives include Alesse, Levlite from Berlex Laboratories of Montville, NJ, Loestrin 1/20 from Parke-Davis of Morris Plains, NJ, and Mircette from Organon of West Orange, NJ.
Levlite, like Alesse and Aviane, contains 100 mcg of levonorgestrel, while Loestrin is formulated with 1 mg of norethindrone acetate. Mircette differs in both its dosing regimen and progestin. It relies on 21 days of 20 mcg of ethinyl estradiol and 150 mcg of the progestin desogestrel, followed by two days of placebo pills, completed by five days of 10-mcg pills of ethinyl estradiol. (More information on these pills can be found in the following issues
of Contraceptive Technology Update: Levlite, November 1998, p. 145; Mircette, July 1998,
p. 85; Alesse, August 1997, p. 93.)
Results of the 2000 CTU Contraception Survey indicate that 20-mcg pills are gaining ground on the top choice, Ortho Tri-Cyclen, a 35-mcg ethinyl estradiol/norgestimate phasic pill from Ortho-McNeil Pharmaceuticals. (See results of the 2001 survey in next month’s issue of CTU.)
According to the 2000 survey results, Alesse and Mircette moved up to capture more than 21% of nonformulary responses. The two pills accounted for less than 10% of 1999 responses in the same category. (See the September 2000 issue of CTU for more survey results, and the June 2000 issue, p. 72, for an overview of the trend toward 20-mcg pills.)
Aviane joins Apri
Aviane is Duramed’s second entry into the oral contraceptive market and joins Apri, which was launched in the fourth quarter of 1999. With 30 mcg of ethinyl estradiol and 150 mcg of desogestrel, Apri is the first substitutable product equivalent to Ortho-McNeil Pharmaceutical’s Ortho-Cept and Organon’s Desogen. (CTU reviewed the FDA approval of Apri in its February 2000 issue, p. 19.) The company also markets its own branded estrogen replacement therapy product, Cenestin (synthetic conjugated estrogens), as well as other generic products.
As with Apri, Duramed will be marketing Aviane as a value brand, meaning that the OC can be written as a prescription by providers and/or substituted for the brand product by pharmacists, according to Jeffrey Arington, Duramed president and chief operating officer. The company has additional Abbreviated New Drug Applications for oral contraceptives on file with the FDA, says Zurcher.
First two OCs from Barr
Barr Laboratories’ Nortrel 1/35 is a substitutable product equivalent to Ortho-Novum 1/35, containing 1 mg of norethindrone and 35 mcg of ethinyl estradiol. Nortrel 0.5/35 is the generic equivalent of Modicon-28 and offers 0.5 mg of norethindrone and 35 mcg of ethinyl estradiol.
The two new Nortrel pills represent the company’s first entrants in the oral contraceptive market, says Cox. The company is focusing its sales and marketing efforts on wholesalers and retailers in moving the two OCs as value brands, she states.
"Over the next two years, Barr expects to build a complete line of generic oral contraceptive products that will compete in the $2 billion oral contraceptive marketplace," says Bruce Downey, company chairman and CEO. "We believe that our contraceptive line will offer women less expensive alternatives as they address their family planning needs."
The company is now in Phase III clinical trials with its own pill, Seasonale. The OC uses a patented 84-day dosing regimen, if approved by the FDA, would introduce the first four-periods-per-year pill in the United States. (See the May 1999 issue of CTU, p. 51, for more information on Seasonale.)
Clinical studies on the drug should be finished by January 2002, and its New Drug Application is projected to be filed with the FDA in spring or summer of the same year, says Cox. If the OC does receive FDA clearance, it is projected to be available between May and September of 2003, she states.
For more information on the Nortrel line of OCs, contact:
• Barr Laboratories Inc., 2 Quaker Road, P.O. Box 2900, Pomona, NY 10970-0519. Tele-phone: (800) 227-7522 (BARRLAB). Web: www.barrlabs.com.
For more information on Aviane, contact:
• Duramed Pharmaceuticals, 5040 Duramed Drive, Cincinnati, OH 45213. Telephone: (800) 543-8338. Web: www.duramed.com.
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