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

Amgen’s Challenge Over Sensipar Pediatric Exclusivity Moves To US Appeals Court

Executive Summary

Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.

You may also be interested in...



Launch Abbreviated: Teva Halts US Generic Sensipar Sales After Patent Deal With Amgen

In the course of a week, Teva received final ANDA approval for cinacalcet, launched its generic and reached a deal with Amgen to come off the market until mid-2021. The fast but short launch allowed Teva to take some sales away from Amgen without triggering entry of other ANDA sponsors who previously settled, Bernstein Senior Analyst Ronny Gal says.

Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch

Just days after Piramal was one of three generic drug sponsors found not to have infringed a Sensipar formulation patent, FDA approved company’s ANDA, threatening Amgen’s de facto exclusivity on the blockbuster calcium-sensing receptor agonist.

Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch

Just days after Piramal was one of three generic drug sponsors found not to have infringed a Sensipar formulation patent, FDA approved company’s ANDA, threatening Amgen’s de facto exclusivity on the blockbuster calcium-sensing receptor agonist.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS123127

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