Abstract
From emerging specialist companies to established generic producers,
alternative drug delivery technologies are increasingly being seen as a route
to a competitive edge in the generics industry.
While controlled-release products have traditionally been developed towards
the patent-expiry, companies are now beginning to look at controlled-release
delivery earlier in the product life-cycle and, in some cases, are launching
immediate- and controlled-release versions of new drugs to address the
differing needs of patients.
A number of significant controlled-release drugs - some of them blockbusters
- will lose patent protection in the medium term. This has led to increased
interest from a range of companies vying for a share of the controlled-release
generics market.
Fewer competitors, higher margins
It' s an attractive area: due to the significant technical barriers to the
development of controlled-release drugs, they will generally have fewer
competitors in the marketplace and, therefore, will attract higher prices and
greater revenue opportunities than the highly competitive instant-release
formulations.
A US$15 billion sector
The controlled-release drugs reviewed in this report had combined sales of
more than US$15 billion in 2008. While the majority of these have patent
protection for the controlled-release formulation, the validity of these
patents is often the subject of litigation, particularly in the US where
companies frequently file Paragraph IV certifications under the Hatch-Waxman
act. In some cases, these legal challenges result in agreements between
generic companies and originators, allowing the limited introduction of
generics some years prior to patent expiry.
Identify key product opportunities, patent status and the activities of
companies competing across all delivery platforms in this rapidly-developing
growth area with this new 125+ page report:
Assess the current position and future potential of 30 CR therapies in key
therapy areas Evaluate the activities of 13 companies active in the field
Review the sector' s position in the context of the broader generic market
A case in point...
Wyeth' s Effexor XR
One of the most hotly contested controlled-release drugs in recent years has
been Wyeth' s US$3 billion Effexor XR (venlafaxine). A number of companies have
filed ANDAs with the FDA for generic versions of Effexor XR, prompting Wyeth
to file patent litigation suits. As of July 2009, cases against six companies
remain outstanding: Sandoz, Mylan, Wockhardt, Biovail, Torrent and Apotex. To
date, Impax and Mylan have received tentative approval for their ANDAs for
generic venlafaxine controlled-release capsules.
In addition, Osmotica has an FDA-approved NDA for a controlled-release tablet
form of venlafaxine. Understandably, this also prompted Wyeth to file a patent
infringement lawsuit. Under a 2008 agreement, however, Osmotica was granted a
licence in exchange for paying Wyeth a royalty on sales. Litigation has also
been settled with Impax, Lupin, Anchen Pharmaceuticals and Teva Pharmaceutical
Industries; three of these companies will be free to introduce generics under
licence in 2011, while Teva will be able to launch a generic in July 2010,
assuming FDA approval.
A win-win situation?
Licence agreements offer potential benefits to both generic companies and the
originator. For the latter, it is a way of limiting early generic competition
and cushioning the blow of revenue erosion by demanding royalty payments.
Generic companies benefit from early market entry with limited competition,
enabling them to establish their position prior to the expiry of the final
patent when potentially more competitors can gain market approval. In the case
of Effexor XR, Wyeth' s final patent is not due to expire until 2017, providing
a handful of companies with several years of limited competition for the price
of royalty payments on what could be significant revenue for this blockbuster
product.
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