Teva Stays One Step Ahead Of Generics With Single-Dose Plan B

Teva Pharmaceutical Industries will likely extend its market exclusivity to Plan B emergency contraceptive via a new dosage formulation. A spokeswoman said the company expects to have three years of exclusivity for its levonorgestrel 1.5-mg tablet Plan B One-Step, or until July 10, 2012.

   

The firm announced the drug's approval by FDA today. 

Teva's exclusivity for Plan B in its two-dose 0.75-mg formulation expires Aug. 24. The firm is discontinuing the two-dose formulation and expects to have One-Step available by August, the spokeswoman said.

In addition to approving the single-dose contraceptive, FDA has also granted Plan B nonprescription access to women 17 years old, which it said it would do following a court decision that objected to the agency's original Plan B approval process (as Over the Counter Today discussed here and "The Tan Sheet" reported here).

Plan B's dosing instructions call for two tablets taken 12 hours apart, but clinical data support the safety and efficacy of taking a single dose of 1.5 mg of levonorgestrel. One-Step's prescribing information says the single 1.5-mg dose prevented 84 percent of expected pregnancies in a study, compared to 79 percent of expected pregnancies among women taking two-dose Plan B. 

By coming out with One-Step just as its market exclusivity runs out for original Plan B, Teva is keeping one step ahead of generic competition. Watson Pharmaceuticals expects to launch a nonprescription version of its Next Choice levonorgestrel equivalent in August (as we recently blogged here).

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- Dan Schiff (d.schiff@elsevier.com)