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


“Old” Antibiotics May Get Exclusivity Under New Law; 10 Drugs Could Benefit

Executive Summary

Drug manufacturers could get marketing exclusivity for a handful of old antibiotics under legislation passed by the House and Senate last month

You may also be interested in...

ViroPharma’s Failed Exclusivity Bid For Vancocin Could Spur Congress To Act

FDA’s decision that vancomycin oral capsules do not qualify for Hatch-Waxman marketing protection under a 2008 law could become the focus of a legislative “fix” in pending user fee bills if lawmakers disagree with the agency’s conclusion that only approval of a “significant new use” for older antibiotics warrants exclusivity.

Vancocin Generics Launch As FDA Finds ViroPharma’s Label Fails “Significant New Use” Test

FDA delivers an 87-page chef d'oeuvre that concludes the ViroPharma’s long-running battle to block ANDA approvals. In the citizen petition response, FDA rejects the firm’s scientific and legal arguments and concludes the antibiotic is not eligible for three years of Hatch-Waxman marketing exclusivity under a 2008 law. Although ViroPharma says it plans to sue FDA, the company may have bigger problems on its hands with an FTC investigation.

"Old" Antibiotics Face More Generic Pressure After FDA Denies 30-Month Stays

Teva's brief at-risk launch of the acne product Solodyn followed by a settlement with Medicis may serve as template.




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