Tri-Cyclen Lo is a combination pill containing estrogen (Ethinyl estradiol) and progestin (norgestimate). Tri-Cyclen Lo belongs to the class of medications called oral contraceptives (birth control pills) used to prevent pregnancy.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Each white tablet contains 0.180 mg of norgestimate plus 0.025 mg of Ethinyl estradiol. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and carnauba wax.
Each light blue tablet contains 0.215 mg of norgestimate plus 0.025 mg of Ethinyl estradiol. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, carnauba wax, hydroxypropyl methylcellulose, FD&C Blue No. 2 Aluminum Lake, titanium dioxide, and polyethylene glycol.
Each dark blue tablet contains 0.250 mg of norgestimate plus 0.025 mg of Ethinyl estradiol. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, carnauba wax, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 Aluminum Lake, and polysorbate 80.
In the 28-day regimen, the green tablets do not contain any active medication. Nonmedicinal ingredients: lactose, starch, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, FD&C Blue No. 2 Aluminum Lake, and yellow iron oxide.
Hormones in birth control pills prevent pregnancy by Stopping or reducing ovulation (the release of an egg from an ovary) and thickening cervical mucus to keep sperm from entering the uterus. Birth control pills are a safe, simple, and convenient way to prevent pregnancy. It also has other benefits like reducing acne, making your periods lighter and more regular, and easing menstrual cramps.
Why Was Ortho Tri Cyclen Lo Discontinued?
Tri Cyclen was discontinued because of a patent infringement battle between brand manufacturer Janssen Pharmaceuticals and the generic manufacturer Teva Pharmaceuticals and not as a result of quality or safety concerns.
In 2009, both companies settled the patent infringement lawsuit and as part of the settlement, Teva, which briefly sold its generic version earlier before ceasing shipments, obtained a license to re-enter the market on December 31, 2015, or earlier in certain circumstances.
Israel-based Teva, the world’s largest generic drugmaker, also paid J&J a royalty based on sales of its generic that it shipped. Ortho Tri-Cyclen Lo had annual U.S. sales of about $400 million for that year, according to data provided by Teva.
The settlement comes as U.S. antitrust regulators and Congress are taking a closer look at patent settlements between brand and generic drug makers amid allegations that they shortchange consumers by delaying the arrival of low-cost generic drugs while the company profits. Many settlements that have drawn objections involved a payment from brand companies to generic firms — what critics call “pay-for-delay” deals.
