Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


All Orphans Must Get 10-Year Exclusivity, Says Top EU Court

This article was originally published in SRA

Executive Summary

In a judgment that upholds a central tenet of Europe's Orphan Drug Regulation, the Court of Justice of the EU has ruled that all orphan medicines are entitled to a full 10-year period of market exclusivity, even if they have been approved as "similar" to an existing orphan drug1.

You may also be interested in...

Changes To EU Orphan Similarity Concept Could Change Innovation Threshold For 10-Year Exclusivity

The European Commission has proposed changes to the existing criteria used for determining whether a new medicinal product is similar to an already authorized orphan drug and, therefore, whether it can be accepted for evaluation and granted 10-year market exclusivity.

EMA Endorses Use Of Dexamethasone In COVID-19

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

UK Presents New Licensing Pathway For Innovative Drugs

A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts