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

UsernamePublicRestriction

Generic Lipitor Era Dawns With Watson’s Launch, Followed By Ranbaxy’s Last-minute Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

Teva will share in Ranbaxy’s profits during its exclusivity period, as FDA announces approval of Ranbaxy’s first-filed ANDA more than 14 hours after Watson discloses that it began shipping its atorvastatin “authorized generic”.

You may also be interested in...



Nexium Generics: Ranbaxy’s Exclusivity Loss Is Teva’s Gain

Teva’s readiness for approval prompts FDA conclusion that Ranbaxy forfeited its rights to 180-day exclusivity for AstraZeneca’s proton pump inhibitor; Ranbaxy is still making its case in court, but episode is suggestive of FDA’s increasing emphasis on application quality.

Pfizer Downplays Risk Of Tofacitinib Panel Review As It Pushes Focus On Innovation

Capital allocation and business re-structuring dominated the conversation during Pfizer’s Q1 earnings call –its first full quarter without Lipitor exclusivity, even as the company waits for near-term regulatory decisions on key compounds.

Ranbaxy’s $500 Million GMP Settlement Would Be Second Most Expensive For Rx Manufacturing Violations

Ranbaxy Laboratories said it has signed a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation involving GMP violations and data integrity issues at its Indian facilities.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073105

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