Generic Ortho Tri-Cyclen Lo Launched

A generic equivalent of Janssen’s norgestimate/ethinyl estradiol (Ortho Tri-Cyclen Lo) tablets has been launched in the United States by Teva Pharmaceutical Industries.

Teva’s product, Tri-Lo-Sprintec, is an oral contraceptive that is available in a 28-day blister pack.

The contraceptive does not protect against HIV infection or other sexually transmitted diseases.

Adverse effects associated with Tri-Lo-Sprintec include headache, nausea, breast issues, abdominal pain, mood disorders, acne, and fatigue.

In a clinical trial observing 1673 subjects during 11,003 cycles of Tri-Lo-Sprintec, researchers recorded 20 pregnancies. This data represents an overall use-efficacy pregnancy rate of 2.36 per 100 women-years of use.

Researchers noted that the overall effectiveness of the drug is improved by proper, consistent use.

For the fiscal year ending in October 2015, IMS reported that Ortho Tri-Cyclen Lo had annual sales of approximately $488 million in the United States.