Medicines Q&As
Q&A 267.5
Drug patents: which will expire in 2013 and 2014?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date prepared: 25 March 2013
Background
The Intellectual Property Office, formerly called the Patents Office, describes a patent as ‘a form of
Intellectual Property that protects new inventions and covers how things work, what they do, how they
do it, what they are made of, and how they are made. It gives the owner the right to prevent others
from making, using, importing or selling the invention without permission’. In the UK, patents’
legislation is embodied in the 1977 Patents Act, which was the first significant revision of patent law
for nearly 100 years.
Pharmaceuticals are fully covered by patent legislation. Patents applying to pharmaceuticals cover
many aspects, including their manufacture, formulation and, in some cases, their use. Once a patent
on a drug has expired, especially that relating to the processes of its manufacture, generic versions of
the drug can be manufactured and marketed. It is of interest to the NHS to know when the patent of a
drug is due to expire to facilitate planning for the possible introduction of generic alternatives, with the
normally associated cost reductions.
Answer
The basic patent is rarely the only protection involved and other process, chemical form, or
formulation patents may be relevant. These may all extend the effective patent life of a product. The
basic expiry date can only be taken as a guide to the earliest possible date for any generic form to
appear. Patents on specific formulations or chemical variations, for example new salts, can delay the
introduction of generic brands
A Supplementary Protection Certificate (SPC) is a mechanism to guarantee a certain marketing
exclusivity period for medicines throughout the European Union (EU), to allow for the extended
development period they require. Current patents in the EU are valid for 20 years; an SPC applies
from the date of first marketing of a product within the EU, and extends the effective patent life for up
to 5 years, to allow up to a maximum of 15 years exclusivity.
Extensions to SPCs arising from paediatric trials: On 26 January 2007, regulation (EC) No.
1901/2006 came into force. This Regulation sets out the new legislative framework to promote the
development of medicinal products for use in the paediatric population. Amongst its incentives is the
possibility of an extension to the duration of a SPC covering a marketed medicinal product. Before
this regulation came into force, the maximum duration of an SPC was five years. Now, under the
provisions of the new Regulation, an SPC covering a product may be extended (beyond the term that
it would otherwise be afforded) by a period of six months. This extension of term applies to all of the
authorised indications for the product (including the non-paediatric indications).
Drugs currently available on the UK market whose patents, including those with SPC extensions, are
due to expire in the next 2 years are:
From the NHS Evidence website www.evidence.nhs.uk
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Medicines Q&As
Patents expiring in 2013
Approved Name
BNF
UK-patent
expiry
Patents expiring in 2014
Approved Name
BNF
UK-patent
expiry
Abacavir *
5.3.1
27/06/2014
Alemtuzumab *
8.2.3
09/02/2014
Almotriptan *
4.7.4
22/12/2014
Anakinra *
10.1.3
25/05/2014
Bevacizumab *
8.1.5
27/12/2014
Brinzolamide *
11.6
16/12/2014
08/11/2013
Cetuximab *
8.1.5
14/09/2014
11.6
05/03/2013
Escitalopram oxalate *
4.3.3
31/05/2014
Efavirenz 
5.3.1
19/11/2013
14.4
07/03/2014
Etonogestrel 
7.3.1
06/07/2013
Human papilloma virus
vaccine
Fosphenytoin sodium 
4.8.2
03/02/2013
Hydroxyethyl starch *
9.2.2
21/06/2014
Ganirelix *
6.7.2
03/02/2013
Icatibant acetate *
3.4.3
20/11/2014
Hydroxyethyl starch 
9.2.2.2
19/11/2013
Moxifloxacin *
5.1.12
20/06/2014
Irbesartan
+hydrochlorothiazide
2.5.5.2
14/10/2013
Nelfinavir mesylate
5.3.1
07/10/2014
Omalizumab *
3.4.2
27/12/2014
Montelukast sodium 
3.3.2
24/02/2013
Paliperidone *
4.2.1
29/10/2014
Nelarabine 
8.1.3
26/05/2013
Palivizumab *
5.3.5
12/08/2014
Nevirapine 
5.3.1
22/06/2013
Panitumumab
8.1.5
14/09/2014
Raloxifene HCl
6.4.1.1
04/08/2013
Rosiglitazone *
6.1.2.3
28/09/2014
Rituximab
8.2.3
21/11/2013
Sibutramine HCl *
4.5.2
12/01/2014
Rizatriptan 
4.7.4
10/08/2013
Somatropin (synthetic
hGH) *
6.5.1
21/03/2014
Salmeterol xinafoate+
Fluticasone propionate 
3.2
06/09/2013
Temoporfin *
8.1.5
26/02/2014
Sildenafil 
2.5.1/
7.4.5
21/06/2013
Trastuzumab *
8.1.5
28/07/2014
Ulipristal acetate *
7.3.5
22/06/2014
Telmisartan 
2.5.5.2
10/12/2013
Verteporfin *
11.8.2
18/07/2014
Tirofiban HCl 
2.9
27/05/2013
Zanamivir *
5.3.4
08/02/2014
Zidovudine + Lamivudine 
5.3.1
17/03/2013
Zoledronic acid 
6.6.2
15/05/2013
Atovaquone + Proguanil
5.4.1
24/11/2013
Basiliximab 
8.2.2
06/04/2013
Bupropion
4.10.2
12/08/2013
Capecitabine 
8.1.3
09/06/2013
Clopidogrel hydrogen
sulphate 
2.9
15/08/2013
Dexketoprofen trometamol
10.1.1
Dorzolamide + Timolol 
 drugs with SPC extension
 drugs with SPC paediatric extension
Summary

The patents of 25 drugs currently marketed in the UK are due to expire in 2013, with a further 25
in 2014.

Some of these will be marketed as generics shortly after the patent expiry, although at present it
is not known which.
From the NHS Evidence website www.evidence.nhs.uk
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Medicines Q&As
Limitations

Although information on patent expiries is in the public domain it is difficult to access and
verify.

The patent expiries listed normally apply only to the basic manufacturing patent. Other
patents may exist covering alternative processes, chemical variations (such as different salts)
and different formulations. For some drugs these may prolong the effective protection from
generic competition from the dates listed.
References
The information on drug patent expiries listed has been acquired form a number of sources:
a. The Intellectual Property Office, Newport, South Wales.
Online Patent Services http://www.ipo.gov.uk/types/patent/p-os.htm
b. MPA Business Services Ltd, London
c. Adis R&D Insight, Wolters Kluwer Health, Chester, 2013
Quality Assurance
Prepared by
Peter Golightly, Trent Medicines Information Service, Leicester Royal Infirmary
Date Prepared
25 March 2013
Checked by
Laura Kearney, Trent Medicines Information Service, Leicester Royal Infirmary
Date of check
26 March 2013
Search strategy
UKMi Database of Drug Patents Database. http://www.ukmicentral.nhs.uk/pressupp/pe.htm
From the NHS Evidence website www.evidence.nhs.uk
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