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Patent expiries 2019-21

Eight more to come this year

February 21st 2019

Tagged: DM Zone news Clinical Zone news

By DDA Board Member Philip Koopowitz

The following table highlights the drugs which are expected to come off patent over the next three years.

Drugs initiated mainly in primary care have been listed and many of the anti-neoplastic and monoclonal antibody drugs have not been included as they are mainly hospital-only.

Generic Name Brand Name Patent expiry Month
Simvastatin + Ezetimibe Inegy April
Atomoxetine Strattera May
Insulin detemir Levemir May
Solifenacin succinate Vesicare Jun
Roflumilast Daxas Jul
Colesevelam Cholestagel Sep
Insulin glulisine Apidra Sep
Rasagiline Azilect Oct
Aliskiren Rasilez Apr
Tapentadol Palexia Jul
Prucalopride Resolor Nov
Rotigotine Neupro Feb
Beclometasone diproionate + formoterol fumarate Fostair Jul
Varenicline Champix Sep
Dienogest + estradiol valerate (Qlaira®) Qlaira Oct
Exenatide Byetta Nov
Amlodipine + valsartan Exforge Dec


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 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 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 becomes available commercially.

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

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