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.
| Drug | BNF | 2017 patent expiry date
*= UK patent only, no SPC |
Date includes
paediatric extension |
Generic or biosimilar
Available/in development |
| Telmisartan/hydrochlorothiazide | 2.5.5.2 | January | Yes | |
| Velaglucerase alfa | 9.8.1 | January | ||
| Olmesartan medoxomil | 2.5.5.2 | February | Yes | |
| Bimatoprost | 11.6 | March | Yes | |
| Icatibant | 3 | March | ||
| Valganciclovir | 5.3.2.2 | March | Yes | Yes |
| Caspofungin | 5.2.4 | April | Yes | Yes |
| Entecavir | 5.3.3.1 | April | Yes | |
| Ertapenem | 5.1.2.2 | April | ||
| Melatonin | 4.1.1 | April | ||
| Parecoxib | 15.1.4.2 | April* | ||
| Tramadol/paracetamol | 4.7.2 | April | ||
| Olopatadine | 11.4.2 | May | ||
| Peginterferon alfa | 8.2.4 | May* | ||
| Tegafur/gimeracil/oteracil | 8.1.3 | May | ||
| Travoprost | 11.6 | May | Yes | Yes |
| Nitisinone | 9.8.1 | June | ||
| Dutasteride | 6.4.2 | July | Yes | |
| Etoricoxib | 10.1.1 | July* | Yes | |
| Pregabalin | 4.8.1 | July* | Yes | |
| Bosentan | 2.5.1 | August | Yes | Yes |
| Estradiol/drospirenone | 6.4.1.1 | August* | ||
| Norelgestromin | 7.3.1 | August | ||
| Omalizumab | 3.4.2 | August | ||
| Pegfilgrastim | 9.1.6 | August | Yes | |
| Ivabradine | September | |||
| Prasugrel | 2.9 | September | ||
| Ezetimibe | 2.12 | October | Yes | |
| Mucophenolate mofetil E/C | 8.2.1 | October | Yes | |
| Pegvisomant | 6.5.1 | November | ||
| Tadalafil | 2.5.1/7.4.5 | November | Yes | |
| Abatacept | 10.1.3 | December | Yes | |
| Retigabine | 4.8.1 | December | ||
| Rosuvastatin calcium | 2.12 | December | Yes | Yes |
| 2018 | ||||
| Abiraterone | 8.3.4.2 | March | ||
| Anidulafungin | 5.2.4 | March | ||
| Adalimumab | 1.5.3 / 10.1.3 | April | Yes | |
| Enfuvirtide | 5.3.1 | April | ||
| Everolimus | 8.1.5 | July | ||
| Varicella-zoster vaccine | 14.4 | July | ||
| Human papilloma virus vaccine (Cervarix) | 14.4 | September | ||
| Vardenafil HCl | 7.4.5 | October* | ||
| Aprepitant | 4.6 | November | ||
| Insulin detemir | 6.1.1.2 | November | ||
| Oxycodone/naloxone | 4.7.2 | December* | ||
| Solifenacin succinate | 7.4.2 | December | Yes |
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.