LONDON (Reuters) - Teva Pharmaceuticals does not expect to see the launch of generic copies of GlaxoSmithKline’s best-selling lung drug Advair that could be sold as a true substitute to U.S. patients before 2018.
The cautious comments by the world’s biggest maker of generic medicines during an investor presentation on Tuesday is good news for GSK shareholders, who had feared cheaper forms of the $8 billion-a-year seller might come around two years sooner.
Deutsche Bank analysts said that pushing back generic competition to Advair by 18-24 months would boost GSK’s mid- to long-term earnings outlook and give GSK more time to promote two newer respiratory drugs, Breo and Anoro.
Speculation about an earlier launch of generic Advair was fuelled last month by a draft guidance document from the Food and Drug Administration setting out relatively lenient requirements for generic versions of the inhaled drug.
Teva, however, said that producing a substitutable, or so-called AB-rated, version of Advair would still be challenging and slides posted on its website stated it did not expect to see such a product on the all-important U.S. market before 2018.
Advair, which is marketed as Seretide outside the United States, is used to treat both asthma and chronic lung disease caused by smoking.
Although patents on the active ingredients used in the medicine have expired, it remains protected by U.S. patents on the Diskus inhaler device that run until 2016 - and, even then, generics companies face hurdles in making high-quality copies.
GSK has always said it would be difficult for generics firms to make an effective substitute for its popular product.
Reporting by Ben Hirschler; editing by Tom Pfeiffer