More generic OC options on the way

Get set to add more generic oral contraceptives (OCs) to your list of available birth control options as Corona, CA-based Watson Pharmaceuticals is rolling out its brand equivalents of Ortho-Cyclen and Ortho-Novum 7/7/7, two popular pills originally developed by Raritan, NJ-based Ortho-McNeil Pharmaceutical.

The two Watson OCs, MonoNessa and Necon 7/7/7, were scheduled for product launch at Con-traceptive Technology Update’s press time, reports Patty Eisenhaur, the company’s director of inves-tor relations. The company entered into a supply arrangement in October 2002 with OMJ Pharmaceutical, an affiliate of Ortho-McNeil Pharmaceuti-cal, for a portfolio of oral contraceptives.

Necon 7/7/7, like Ortho-Novum 7/7/7, contains 35 mcg of ethinyl estradiol and a phasic (0.5 mg, 0.75 mg, and 1 mcg) dose of the progestin norethindrone. MonoNessa, like its brand equivalent Ortho-Cyclen, is formulated with 35 mcg of ethinyl estradiol and 0.25 mg of the progestin norgestimate. Barr Laboratories of Pomona, NY, also offers brand-equivalent options of the two Ortho-McNeil drugs: Nortrel 7/7/7 and Sprintec. (CTU reported on Barr Labs’ additions in its December 2002 article, "Pill options expand with new, generic OCs," p. 140.)

As brand equivalents, the two Watson Pharma-ceuticals pills follow in the stead of two popular OCs: Ortho-Novum 7/7/7 has been a longstanding phasic pill choice, and Ortho-Cyclen is consistently in the top three choices of birth control pill options in CTU’s annual Contraception Survey. Ortho-Cyclen ranked third in the 2002 survey in formulary and nonformulary choices for 21-year-old nonsmokers, following Ortho Tri-Cyclen, another phasic 35-mcg pill from Ortho-McNeil, and Alesse, a 20-mcg monophasic pill from Wyeth-Ayerst Laboratories of Philadelphia. (See the CTU article, "Pill still is popular family planning choice," in the November 2002 issue, p. 124.)

A generic acne pill’?

Family planning providers may see a generic version of Ortho Tri-Cyclen later this year. Watson Pharmaceuticals and Barr Laboratories have announced plans to launch their versions of the popular pill, respectively tradenamed TriNessa and Tri-Sprintec. Availability hinges on whether Ortho-McNeil receives an additional six months’ exclusivity on its product following the scheduled September 2003 patent expiration.

Since Ortho Tri-Cyclen received an indication for the treatment of mild to moderate acne from the Food and Drug Administration (FDA) in January 1997, it has become the nation’s leading prescribed birth control pill.1 (See the March 1997 CTU article, "Ortho Tri-Cyclen first low-dose OC to be indicated for noncontraceptive use," p. 25.) Thanks to an aggressive print and media advertising campaign, women often come into providers’ offices requesting prescriptions for "the acne pill."

Kerry Raghib, CNM, MSN, a nurse-midwife at Trinity Medical Center, Medical Arts Clinic in Minot, ND, says generic OCs are used at her facility, with Watson Pharmaceuticals’ Necon line being the most common selections. When a generic version of Ortho Tri-Cyclen becomes available, she says it will be offered at her clinic.

Are generic OCs available at your facility? For many family planning clinics, the discount pricing offered through bulk or nonprofit purchasing programs makes branded products the most cost-effective choice.

Michele Van Vranken, MD, medical director of the Annex Teen Clinic and West Suburban Teen Clinic in Minneapolis, says generic OCs are not used at any of her facilities.

"At two of the clinics, we use Ortho-Novum, Ortho-Cyclen, and Ortho Tri-Cyclen, but get a significant discount from Ortho as nonprofit entities," she states." We would consider using generics, though pricing will be a factor, and I don’t know that the generics will be less than the discount currently offered."

Are generic oral contraceptives as effective as brand-name pills? First, it is important to understand what constitutes a therapeutic equivalent drug. For two products to be considered pharmaceutically equivalent, they must contain the same active ingredients and be identical in strength, dosage form, and route of administration. Bioequi-valence is achieved if the generic product demonstrates no substantial difference in rate or extent of absorption when compared to the reference drug.2 Multisource drug products listed under the same heading — identical active ingredients, dosage form, and route of administration — and having the same strength generally will be coded AB if a study is submitted demonstrating bioequivalence. All the bioequivalent hormonal contraceptives on the market today are AB-rated.3

FDA approval guidelines for generic products require one small crossover study to demonstrate bioequivalence.4 The FDA considers two products bioequivalent if the extent of absorption for the generic is 80%-125% of that of the brand-name drug.4 No data are available for clinicians to review the occurrence of side effects, breakthrough bleeding, or unintended pregnancy between generic and brand-name OCs; the FDA does not require these studies for approval of generic drugs.4 (The Washington, DC-based Association of Reproductive Health Professionals addresses the use of generic OCs in the August 2001 electronic edition of its publication, Clinical Proceedings; to review, go to www.arhp.org and click on "Health Care Providers," "Online Publications," "Clinical Proceedings," and "Understanding Low-Dose Oral Contraceptives.")

For patients who pay for prescriptions at retail pharmacies, however, the reduced price of generic products can be attractive. Insurance prescription plans may not cover contraceptives, so women may be looking for cost savings when it comes to directly paying for birth control.

References

1. Acne indication puts oral contraceptive above the pack. Milo Gibaldi Pharmaceutical Report. March 1, 2000. Accessed at: www.aaps.org/news/articles/2000/030100pharmreport.asp.

2. Ansbacher R. Low-dose oral contraceptives: Health consequences of discontinuation. Contraception 2000; 62:285-288.

3. Chase SL, Mackowiak E. Contraceptives: Which one is right for your patients? Pharmacy Times. Accessed at http://secure.pharmacytimes.com/lessons/html/contraceptives.htm.

4. Bioequivalence between brand-name and generic OCs. Contraception Report 2002; 13:6-9.