Ukmi q&a xx

Patent expiries: Which drugs have price reductions?
Adapted from Drug patents: which will expire in 2012 and 2013? UK Medicines Informationharmacists for NHS healthcare professionals The patents of 25 drugs currently marketed in the UK are due to expire in 2012, with a further 21 in 2013. Some of these will be marketed as generics shortly after the patent expiry, although at present it is not known which.
Drugs with expired patents (as at July 2012)

Approved Name
BNF section
Significant Price reduction?a
Patent expired 28/4/12 but NO price reduction yet Patent expired 14/4/12 but NO price reduction yet Patent expired 15/1/12 but NO significant price Patent expired 18/2/12 but NO price reduction yet Patent expired 9/3/12 but NO price reduction yet Patent expired 24/2/12 but NO price reduction yet YES but only on TABLET forms of valsartan alone, and the Valsartan 160mg / Hydrochlorothiazide 12.5mg tablet combination (no other strengths) YES but only 2.5mg strength (tabs and orodisp). 5mg orodisp and nasal spray remain very expensive Medicines Management Team
Original document available from the National Electronic Library for Medicines. Drugs currently available on the UK market whose patents, including those with SPC extensions, are due to expire in the next 2 years are:
Patents expiring in 2012 of interest for primary care prescribing:

Approved Name
UK-patent expiry
Patents expiring in 2013 of interest for primary care prescribing:
Approved Name
UK-patent expiry

Further information on patents
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’
Original document available from the National Electronic Library for Medicines. 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. 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).
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. i References
The information on drug patent expiries listed has been acquired form a number of sources:
a. The Intellectual Property Office, Newport, South Wales. b. MPA Business Services Ltd, London c. Adis R&D Insight, Wolters Kluwer Health, Chester, 2011 Original document available from the National Electronic Library for Medicines.



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