Teva Pharmaceutical Industries Ltd (ADR) (TEVA) Requests Stricter Approval Requirements For Copaxone Generics

Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) will have to wait for a court ruling over its IP protection for its lifelong multiple sclerosis therapy, Copaxone. But even as it holds onto positive expectations, the Israeli drugmaker has presented a 124-page document to the FDA. It is seeking to convince the regulator of the need to have stricter approval requirements for new Copaxone generics compared to those for knockoffs of Teva’s 20-mg formulation.

Inasmuch as Teva may want the FDA to move with speed in meeting its request, it is likely that the regulator may have to pause for a while to have a careful look at the data presented, given that Teva is an interested party here.


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Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) Has Occasionally Turned To The FDA For Rescue

This is not the first time that the Petah Tikva-based company is seeking the help of the FDA in its attempts to throw a hurdle in its rivals’ paths. It has previously filed many citizens’ petitions meant to stall Glatopa but was not successful. On the other hand, the company has been facing stiff competition, which has hit back at its shares. Its current status is worrisome even to investors who say that it was last experienced during the leadership of former CEO Jeremy Levin.

Analysts have also raised their concerns and in reference to the 124-page document, Bernstein analyst Ronny Gal wrote, “Teva’s document is well-written, fact-based and strikes the right tone.” However, he further stated, “the document presents just “one side’s view of the data.”

How Stable Is Teva’s Future?

While it is not clear what path the FDA will choose to follow, Gal argues that Teva’s argument may not be strong enough and neither do they have any clinical relevance to sustain its argument. The analysts feel that the court is likely to go the same way the U.S. Patent and Trademark Office’s Patent Trial and Appeals Board did.

Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA)’s stock closed at $42.74, witnessing an increase of $0.42 or 0.99% in yesterday’s session.

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Note: This article is written by Andy Parker and originally published at Market Exclusive.