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UK patent expiries 2017/2018

Updated patent expiry information published

June 27th 2017

Tagged: DM Zone news Clinical Zone news

By Ailsa Colquhoun

UKMi has published the following list of drugs that are expected to come off patent during 2017/2018.

The information is taken from Prescribing Outlook – New Medicines, a horizon scanning resource for the NHS to help with budget setting, prescribing planning and medicines management.

This edition focuses on anticipated UK availability of new medicines or licence extensions due in 2017 or 2018 organised by BNF category and likely commissioning route.

Those with an anticipated launch in 2017 contain clinical and therapeutic data plus information on predicted launch date, potential target population and estimated impact on service delivery and cost. Those with a predicted 2018 launch date and all chemotherapy agents contain briefer information.  Horizon scanning is a rapidly changing field; for more up to date information click on the generic name hyperlinks to take you to the individual monographs on the SPS website.

Sections on biosimilar developments and patent expiries are also included as well as a list of recently launched medicines with links to relevant guidance and reviews.

DrugBNF2017 patent expiry date

*= UK patent only, no SPC

Date includes

paediatric

extension

Generic or biosimilar

Available/in development

Telmisartan/hydrochlorothiazide2.5.5.2JanuaryYes
Velaglucerase alfa9.8.1January
Olmesartan medoxomil2.5.5.2FebruaryYes
Bimatoprost11.6MarchYes
Icatibant3March
Valganciclovir5.3.2.2MarchYesYes
Caspofungin5.2.4AprilYesYes
Entecavir5.3.3.1AprilYes
Ertapenem5.1.2.2April
Melatonin4.1.1April
Parecoxib15.1.4.2April*
Tramadol/paracetamol4.7.2April
Olopatadine11.4.2May
Peginterferon alfa8.2.4May*
Tegafur/gimeracil/oteracil8.1.3May
Travoprost11.6MayYesYes
Nitisinone9.8.1June
Dutasteride6.4.2JulyYes
Etoricoxib10.1.1July*Yes
Pregabalin4.8.1July*Yes
Bosentan2.5.1AugustYesYes
Estradiol/drospirenone6.4.1.1August*
Norelgestromin7.3.1August
Omalizumab3.4.2August
Pegfilgrastim9.1.6AugustYes
IvabradineSeptember
Prasugrel2.9September
Ezetimibe2.12OctoberYes
Mucophenolate mofetil E/C8.2.1OctoberYes
Pegvisomant6.5.1November
Tadalafil2.5.1/7.4.5NovemberYes
Abatacept10.1.3DecemberYes
Retigabine4.8.1December
Rosuvastatin calcium2.12DecemberYesYes
2018
Abiraterone8.3.4.2March
Anidulafungin5.2.4March
Adalimumab1.5.3 / 10.1.3AprilYes
Enfuvirtide5.3.1April
Everolimus8.1.5July
Varicella-zoster vaccine14.4July
Human papilloma virus vaccine (Cervarix)14.4September
Vardenafil HCl7.4.5October*
Aprepitant4.6November
Insulin detemir6.1.1.2November
Oxycodone/naloxone4.7.2December*
Solifenacin succinate7.4.2DecemberYes

Important notes
Expiry dates in the table above take account of any patent extensions afforded by a Supplementary Protection Certificate (SPC) and a paediatric investigation plan, which together can extend a product’s patent – and protection from generic competition – by up to five and a half years.

The table also indicates where a licence for a generic/biosimilar product is in the latter stages of the EU licensing process, or is already available in the EU. However, it does not follow that a generic or biosimilar product will be available in the UK as patent issues vary between countries. Patent legislation is complex and the above table is for guidance only.

Please also note that expected patent expiry dates are subject to change when new extensions (SPC or paediatric) are granted or if a legal decision alters the patent status of a drug. In addition, the expiries listed here only cover the basic manufacturing patent; additional patents on formulations and uses can influence when a generic or biosimilar becomes available commercially.

The DDA cannot be held responsible for any losses resulting from inaccuracies in this table.