Download Tamiflu SPCs expiries clear path in Europe

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Tamiflu SPCs expiries clear path in Europe
I
n several western European countries, mid-June will bring the
expiries of supplementary protection certificates (SPCs) protecting
the Tamiflu (oseltamivir) brand marketed by Roche for the treatment
and prophylaxis of influenza. Those SPCs refer to European patent
EP0,759,917, which is entitled ‘Novel selective inhibitors of viral or
bacterial neuraminidases’ and expired in late-February last year.
While these SPCs continue to cover Tamiflu for the next few
weeks in Austria, Belgium, France, Greece, Italy, Luxembourg, the
Netherlands, Spain and Sweden (see Figure 1), the brand’s protection
is not universal. For example, in the UK, the local SPC GB02/047 held
by Roche’s partner, Gilead, was withdrawn in September 2005.
In May 2014, Actavis obtained a pan-European centralised
marketing authorisation for generic oseltamivir capsules under the
Ebilfumin brand name (Generics bulletin, 4 April 2014, page 15).
Listed by the World Health Organization (WHO) as an essential
medicine, Tamiflu is not far from being a blockbuster, with Roche
posting global sales of the brand ahead by a tenth at constant exchange
rates (CER) to SFr794 million (US$813 million) last year. However,
the generic opportunity in Europe is relatively modest, with Roche’s
annual brand sales in the region coming in at SFr101 million.
Tamiflu has faced generic competition in the US since late last
year after Alvogen in mid-December introduced the rival it had
co-developed with India’s Natco Pharma (Generics bulletin, 16
December 2016, page 11). The first-to-market launch was the result
of a patent- litigation settlement that Alvogen and Natco had struck
with Roche that permitted market entry before the originator’s US
patent 5,763,483 expired on 23 February 2017, including a six-month
paediatric extension (Generics bulletin, 8 January 2016, page 14).
The effect of Alvogen’s market entry is already telling on Roche.
In the first quarter of this year, the Swiss originator saw its US Tamiflu
turnover tumble by 39% to SFr156 million. This pushed down global
sales of the antiviral brand by 27% to SFr270 million, as European
sales slid by 30% to SFr13 million.
Immediately upon the end of the paediatric extension to the US ‘483
patent in late February this year, the US Food and Drug Administration
(FDA) approved a second oseltamivir abbreviated new drug application
(ANDA) filed by Zydus Cadila’s Nesher affiliate (Generics bulletin, 3
March 2017, page 15). Amneal’s ANDA approval followed in mid-May.
June also brings the expiry of SPCs through much of Europe for
Swedish Orphan’s Orfadin (nitisinone), while AstraZeneca’s Crestor
(rosuvastatin) loses its monopoly in Hungary and Switzerland.
Looking at data exclusivity details recorded in its Ark Patent
Intelligence database (see Figure 2), QuintilesIMS observes that Astellas’
Myrbetriq (mirabegron) treatment for overactive bladder will face the
end of its US new chemical entity (NCE) exclusivity on 28 June.
“Mirabegron is one of Astellas’ top drugs for overactive bladder
treatment,” QuintilesIMS notes. Sales of the brand in Astellas’ Americas
region increased by just over a third to US$510 million in its financial
year ended 31 March 2017.
Myrbetriq 25mg and 50mg extended-release tablets are protected by
two patents listed in the FDA’s Orange Book that expire in August 2020
and March 2022, as well as by four other patents with November 2023
expiry dates. However, QuintilesIMS points out that several generics
companies – including Actavis, Apotex, Lupin, Sandoz and Zydus
Cadila – have already filed paragraph IV challenges to several listed
patents. The FDA says it received the first paragraph IV challenge or
challenges on 28 June 2016, the first date possible as it was one year
before the end of NCE protection.
Furthermore, the sole US patent listed against another of Astellas’
key overactive bladder brands, Vesicare (solifenacin succinate) tablets,
expires on 19 November 2018. Under the terms of a litigation settlement
over US patent 6,017,927, Teva can launch in October next year. G
SPC expiries in June
Data exclusivity expiries in June
INNCountry
INNCountry
Abatacept
AliskirenSwitzerland
Norway, Switzerland
Drotrecogin alfa (activated) Austria, France, Germany, Greece, Italy,
Luxembourg, Slovenia, Sweden
BelataceptTurkey
FrovatriptanSwitzerland
CyclizineAustralia
MaropitantIreland
Human C1 Esterase Inhibitor (Cinryze)
Turkey
MoxifloxacinSlovakia
Hydroxycarbamide
European Union
Nitisinone
Austria, Belgium, Denmark, France,
Germany, Greece, Ireland, Italy,
Luxembourg, Netherlands, Norway,
Spain, Sweden, UK
LorcaserinUS
Oseltamivir
Austria, Belgium, France, Greece, Italy,
Luxembourg, Netherlands, Spain, Sweden
Rosuvastatin
Hungary, Switzerland
Figure 1: Molecules for which supplementary protection certificates (SPCs)
expire in certain markets in June 2017 (Source – Ark Patent Intelligence)
CabazitaxelCanada*
Melatonin
European Union
MirabegronUS
RufinamideCanada*
Ustekinumab
South Korea
* 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.
Figure 2: Molecules for which data exclusivity expires in certain markets during
June 2017 (Source – Ark Patent Intelligence)
This monthly update of key patent, SPC and data exclusivity data is extracted from QuintilesIMS’ Ark Patent Intelligence Expiry
Database. Covering 130 countries and over 3,000 INNs, Ark Expiry Database contains watertight
data teamed with the ultimate in generic launch analysis.
For further information, visit www.arkpatentintelligence.com
or e-mail: [email protected].
12 GENERICS bulletin
2 June 2017