When will the patent for the drug Elvanse expire so that substitutes can appear in Poland? The information from Google is ambiguous, including: "As of June 2020, Takeda has patent protection for lisdexamfetamine in Japan, USA and European Union, with an expiry in June 2029, February 2023 and June 2024 (Extended expiry of February 2028 or March 2029 in certain countries), repectively ." Mainly the date "June 29, 2023" scrolls, but probably it concerns the more twin Vyvanse and it is in the USA. The manufacturer of the original drug Elvanse did not finally decide to introduce it to the Polish market due to the lack of reimbursement. Target import is difficult to implement procedurally, and the price is prohibitive.
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I would like to kindly inform you that the Supplementary Protection Certificate (SPC) for medicinal products and plant protection products is a separate protection title from the patent. The additional protection right provides legal protection for specific products manufactured according to a patented invention after the patent protection expires. The supplementary right of protection takes effect at the end of the legally established period of validity of the basic patent and remains in force for a period equal to the period that elapsed between the date of filing the application for the basic patent and the date of the first authorisation to place the product on the market in Poland or another european Union country or in a Member State of the European Free Trade Agreement (EFTA) – a party to the Agreement on the European Economic Area (depending on from the earlier one), reduced by a period of five years. The period of validity of the certificate may not exceed 5 years. The period of protection may be extended by 6 months for paediatric medicinal products. In the patent indicated by you, the period has been extended by 2 years and 8 months, i.e. until February 1, 2028
As a standard, patent protection for a drug is 20 years, although in the EU it is often extended by another 5 thanks to a dedicated procedure. A generic medicine must not be placed on the market until 10 years have elapsed since the reference (original) product was first authorised in your country. In Poland, the first marketing authorization of Elvanse took place in 2017. The expiration of this time or the end of patent protection does not necessarily mean that generics will be created.
What does it mean in a nutshell?
Olga Sierpniowska Pharmacist
3 years ago
June 29, 2023 is the deadline for the end of patent protection for Vyvanse. Using the data of the Patent Office of the Republic of Poland for lisdexamfetamine, optionally in the form of mesylate or hydrochloride under the name Elvanse, patent rights were filed by Takeda Pharmaceutical Company Limited (according to available data, Takeda acquired Shire in January 2019). The expiration date of the basic patent is 2024-06-01. I attach a link to the threads about the drug Elvanse: https://www.gdziepolek.pl/produkty/96102/elvanse-kapsulki/pytania