Sildenafil SPCs come to an end in Europe
une brings the expiry of supplementary protection certificates (SPCs)
year secured a preliminary injunction that forced the generics firms to
protecting Pfizer’s Viagra (sildenafil) erectile-dysfunction drug in
withdraw their products (Generics bulletin
, 9 March 2012, page 17).
several western European markets, including in France, Germany and
In Germany, Pfizer pre-empted the arrival of competition by
the UK (see Figure 1). Given that Pfizer reported 2012 Viagra sales of
launching its own generic of sildenafil (see page 19). And in the UK,
US$370 million in ‘developed Europe’ out of global brand sales totalling
the British Generic Manufacturers Association (BGMA) expects
US$2.05 billion, the generic opportunity in Europe is considerable.
several players to compete in a market that generated almost 2 million
However, Pfizer appears set to retain the bulk of the brand’s sales
prescriptions over the past year, a fifth of which were in the private sector.
for the foreseeable future. The originator generated US$1.14 billion
Pfizer also markets sildenafil under the Revatio brand name as
– or 55% of global Viagra turnover last year – in the US, where it two
an oral and injectable treatment for pulmonary arterial hypertension.
years ago defeated Teva’s challenge to the validity and enforceability
Revatio generated global sales of US$534 million for Pfizer last year,
of US method-of-use patent 6,469,012, which expires in April 2020
of which US$312 million came in the US, where generic rivals entered
, 2 September 2011, page 19). Teva has appealed,
the market with 20mg tablets towards the end of last year after paediatric
while companies including Actavis, Amneal, Hetero and Mylan have
exclusivity attached to the US molecule patent 5,250,534 expired
, 23 November 2012, page 17). At around the same
Following opposition proceedings before the European Patent
time, Canada’s Supreme Court found Pfizer’s sildenafil method-of-
Office (EPO), a similar method-of-use patent was revoked in Europe.
use patent for erectile dysfunction to be invalid.
The European sildenafil SPC expiries fell on 21 or 22 June in
In Europe, patents protecting the pulmonary-hypertension use were
most western European countries. However, in Spain a similar SPC
revoked. But 10-year orphan exclusivity could prove a barrier to
is set to run until mid-September this year.
filing marketing-authorisation applications that include the patented
Spanish generics companies had previously launched rivals to
indication, according to patent-intelligence specialist GenericsWeb.
Viagra on the basis that the local translation of European molecule
A 10-year data-exclusivity period that protects Eli Lilly’s Forteo
patent EP0,463,756 covered only processes for making sildenafil
(teriparatide) osteoporosis drug expires during June (see Figure 2).
that could be circumvented. However, Pfizer sought to amend the
However, GenericsWeb observes, the centrally-approved injectable
Spanish patent’s claims to cover the sildenafil molecule, and early last
blockbuster continues to enjoy patent protection in Europe.
SPC expiries in June
Data exclusivity expiries in June
Austria, Belgium, Finland, France, Germany,
Hepatitis B triple antigen Austria, France, Germany, Greece, Italy, vaccine (recombinant)
Omega-3-acid ethyl esters Netherlands, Switzerland
France, Germany, Greece, Ireland, Luxembourg, Netherlands, Norway, Sweden,
* This will be followed by a no-marketing period of two years during which a notice of
compliance will not be granted to a generic manufacturer. In addition, a further sixmonths of data protection will be added to the eight-year term for studies of idursulfase
* indicates expiration of six-month paediatric extension to SPC
and oxaliplatin in paediatric populations.
Figure 1: Molecules for which supplementary protection certificates (SPCs)
Figure 2: Molecules for which data exclusivity expires in certain markets during
expire in certain markets during June 2013 (Source – GenericsWeb)
June 2013 (Source – GenericsWeb)
This data is extracted from the monthly update for Pipeline Scope, an online intelligence tool that provides fast
access to reliable information on key patent, SPC and data-protection expiries, covering 44 countries and over 1,500 INNs.
For further information, visit www.genericsweb.com, or contact:
Europe: +44 870 879 0081 North America: +1 704 665 1986
22 GENERICS bulletin
28 June 2013
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