Israel-based generic drug maker Teva Pharmaceutical Industries Ltd. (TEVA) said Tuesday that the company and Johnson & Johnson's (JNJ) Ortho McNeil Janssen division have agreed to cease shipments of generic versions of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen Lo, pending a preliminary injunction hearing in a related patent infringement case slated to commence on July 15, 2009.
Teva is currently involved in a patent litigation with Johnson & Johnson concerning the product in a US district court. The patents of the original version of the pill are set to expire in 2019. According to IMS sales data, for the twelve months ended March 31, Ortho Tri-Cyclen Lo's sales was about $400 million in the United States.
Last Wednesday, Teva had said that the U.S. Food and Drug Administration granted marketing approval for its Abbreviated New Drug Application, or ANDA, to market the generic version of Ortho Tri-Cyclen Lo. Teva also obtained a 180-day period of marketing exclusivity, since it was the the first company to file an ANDA containing a paragraph IV certification for the product. This means that no other generic version of the pill can be launched for the next six months.
A paragraph IV certificate gives the innovator of the drug the right to file an infringement suit against the generic drug company within 45 days, thus triggering a 30 month automatic delay of the generic approval.
Teva made an "at-risk launch" of Ortho Tri-Cyclen Lo with the trade name Tri-Lo Sprintec. At-risk launches, a practice of launching generic copies of a branded drug even before it has won a court victory, are not new for Teva.
Last week, German pharma company Bayer AG (BAYZF.PK) filed a patent infringement lawsuit against Teva over the latter's application for approval to market a generic form of Bayer's erectile dysfunction drug Levitra before patent expiration. The U.S. patent for the drug expires in 2018. Under federal law, Bayer's suit triggers an automatic 30-month period in which the FDA cannot approve Teva's application, unless a judge rules in Teva's favor before then.
In April, the U.S. District Court for the Southern District of Indiana issued a preliminary injunction to block the launch of a generic version of Eli Lilly & Co.'s (LLY) blockbuster osteoporosis drug Evista by Teva until the court rendered its final ruling.
Teva is not a pure-play on generic drugs and has three lines of business - generic pharmaceuticals, branded pharmaceuticals and active pharmaceutical ingredients, or API. Sales of generic and branded drugs totaled $2.99 billion in the recent first quarter of fiscal 2009, up 24% from last year, while the API business segment generated quarterly sales of $158 million, compared to $153 million in the year-ago period. The company's operations are spread across North America, Europe, Latin America, Asia and Israel. The U.S. accounts for a major chunk of the company's sales. In the first quarter, Teva generated 61% of its sales from the U.S, 24% from Europe and 15% from other international regions.
In Tuesday's regular trading session, TEVA is trading at $49.66, down $0.02 or 0.04% on a volume of 1.02 million shares. In the past 52 weeks, the stock has been trading in a range of $35.89-$50.35.
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