Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA approves first generic of Symbicort for asthma and COPD

By Brian Buntz | March 15, 2022

ViatrisFirst approved in 2006 as an asthma treatment, AstraZeneca’s (LON:AZN) Symbicort (budesonide/formoterol) has also won an indication related to chronic obstructive pulmonary disease (COPD).

Now, FDA has approved the first generic of Symbicort for both indications.

Viatris (Nasdaq:VTRS) partnered with Kindeva Drug Delivery (St. Paul, Minnesota) to manufacture the generic version.

Last week, the companies announced that FDA had tentatively approved the Symbicort generic as a result of patent litigation related to the drug in the U.S. District Court for the Northern District of West Virginia related to AstraZeneca’s Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137.

Symbicort and its generic are drug-device combination products, consisting of a metered-dose inhaler with the corticosteroid budesonide and the bronchodilator beta2-agonist formoterol.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, in a statement.

In AstraZeneca’s annual report, the company referred to Symbicort as one of its “key growth drivers.”

The drug brought in $2.7 million in revenue in 2021.

AstraZeneca has noted that it anticipated pricing pressure for Symbicort in mature markets such as the U.S., European Union, China and Japan.

 

Tell Us What You Think! Cancel reply

Related Articles Read More >

Novartis logo
Novartis mulls sale of $25 billion Sandoz generics arm
Pfizer logo
Pfizer seeks to comply with voluntary Net-Zero Standard by 2040
Fujifilm Diosynth Technologies
Fujifilm to spend $1.6B to bolster cell culture manufacturing services
Zantac
First Zantac trial slated for February 2023

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards