Ortho-McNeil is ready to launch the second pillar in its contraceptive product line defense following the approval of Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Aug. 22.

With the flagship Tri-Cyclen oral contraceptive brand coming up on patent expiration, Ortho is counting on the low dose formulation and the recently approved contraceptive patch Ortho EVRA to maintain its contraceptive franchise. The Tri-Cyclen patent is set to expire in September 2003; Barr has filed an ANDA for generic Tri-Cyclen (¹ Also see "Barr/Enhance Acquisition’s First Product Expected To Be Oxybutynin Ring" - Pink Sheet, 1 April, 2002., p. 30).

During its second quarter conference call July 16, Johnson & Johnson said it would not attempt to defend the Tri-Cyclen franchise beyond 2003 and instead would concentrate on the line extensions. Ortho EVRA (ethinyl estradiol/norgestromin) was approved in November (² Also see "Ortho EVRA Marketing Could Stress Convenience Over Oral Contraceptive" - Pink Sheet, 26 November, 2001., p. 6).

J&J believes the contraceptive line extensions will help the company to expand the overall market for hormonal contraceptives (³ Also see "Ortho Low-Dose OC, EVRA Patch Will Counter Generics Of Tri-Cyclen In 2003" - Pink Sheet, 4 June, 2001., p. 19).

Tri-Cyclen Lo is indicated "for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception," labeling says. Labeling says the product had an overall use-efficacy pregnancy rate of 2.36 per 100 women-years in clinical trials.

Unlike Tri-Cyclen, the 25 mcg tablet is not indicated for the treatment of moderate acne.

J&J R&D Pharmaceuticals Chairman Per Peterson, MD/PhD, told investors in May 2001 that Ortho has "already gotten that message across" of an acne benefit associated with Tri-Cyclen and, hence, did not need to conduct clinical trials for the indication for Tri-Cylcen Lo.

In announcing the approval of Tri-Cyclen Lo, Ortho noted that the drug contains norgestimate, which "is associated with low rates of nuisance side effects such as weight gain, acne and facial hair growth."

Ortho said it will launch Tri-Cyclen Lo "in the fall." The company filed NDA 21-241 in August 2000. The contraceptive has been "approvable" at FDA since June 25, 2001 pending final label negotiations (⁴ Also see "J&J Ortho Tri-Cyclen Lo "approvable"" - Pink Sheet, 1 October, 2001., p. 37).

Tri-Cyclen Lo Clears FDA; Ortho-McNeil Patches Up Contraceptive Line

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