Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

Executive Summary

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

You may also be interested in...



US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.

Blocked By Sublocade: Braeburn Sues To Get Brixadi Buprenorphine Formulation Onto Market

Lawsuit against US FDA challenges scope of three-year exclusivity awarded to Indivior’s Sublocade, the first monthly depot formulation of buprenorphine for treating opioid use disorder.

US FDA’s Transfer Policy For Orphan Drug Designation Under Scrutiny

Braeburn Pharmaceuticals says awarding Indivior’s opioid use disorder treatment Sublocade seven-year orphan exclusivity that flows from a 1994 orphan drug designation for Subutex would be an abuse of the system. The US FDA said it is carefully considering whether Sublocade qualifies for exclusivity ‘within the context of the opioid public health emergency.’

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS140557

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel