Sandoz' and Momenta's stranglehold on the generic Lovenox market appears safe for the time being given FDA's pending questions about Teva Pharmaceutical Industries' ANDA for the low molecular weight heparin.

The Israel-based generic drug maker on Jan. 25 announced receipt of a "minor deficiency letter" from FDA related to its enoxaparin sodium ANDA.

The letter's issuance indicates that FDA has completed its review of Teva's application, the company said. "Prior to potential final product approval, the Office of Generic Drugs requires responses to a short list of questions, which Teva intends to respond to in the near future."

Although Teva does not provide a timeline for further FDA action, every day that passes without approval is another day without competition for the Sandoz/Momenta version of Sanofi-Aventis's anti-clotting agent.

Sandoz/Momenta jointly won a three-way race to become the first generic version of Lovenox on the U.S. market; their ANDA received FDA approval in July 2010 even though it was filed approximately two years after Teva and Amphastar Pharmaceuticals filed their respective applications in 2003.

Sandoz' parent company, Novartis, reported generic enoxaparin sales of $292 million in the 2010 third quarter, making it the most successful injectables launch ever in the U.S., according to the company.

In approving the Sandoz/Momenta product, FDA rejected Sanofi-Aventis' argument that enoxaparin ANDA filers should be required to conduct clinical trials to establish efficacy and safety. Rather, the agency laid out five criteria that it used to make a "sameness" determination relative to Lovenox (Also see "FDA Approves Momenta/Sandoz' Lovenox Generic Without Need For Clinical Studies" - Pink Sheet, 23 July, 2010.).

Questions On Immunogenicity?

Teva does not describe what issues the agency raised in its action letter. However, company officials have previously speculated on possible areas for further inquiry by FDA.

During a Jan. 6 presentation at Goldman Sachs' Healthcare CEO Unscripted Conference, Teva Pharmaceuticals-Americas President & CEO William Marth was asked about the status of the ANDA and the reason for its delayed approval.

"We continue to dialogue with the agency at the management level," Marth said. "We have been told that we will get an answer by the end of January, and so we're pretty optimistic that they will give use an answer." He said the agency could approve the product at that time, require additional information on immunogenicity or raise a more complicated issue.

During Teva's third quarter earnings call on Nov. 2, company officials said they had recently met with representatives from the agency and confirmed that the ANDA meets FDA's criteria for demonstrating sameness. At that time, immunogenicity data were under review at the Office of Biological Products, the company said.

As it awaits ANDA approval, Teva has been forced into a defensive legal position by Sandoz and Momenta, which sued the company in December asserting that Teva's enoxaparin infringes two Momenta patents. The companies seek a preliminary and permanent injunction barring Teva from marketing its generic upon approval (Also see "Momenta, Sandoz Play Patent Defense For A Change, Seek Injunction To Prevent Teva From Launching Generic Lovenox" - Pink Sheet, 2 December, 2010.).

In its response to the lawsuit, Teva denied infringing any valid and enforceable patent claims. It also filed counterclaims seeking declaratory judgments of patent invalidity or non-infringement.

The patent case against Teva is one of three legal challenges related to generic enoxaparin since FDA approved the Sandoz/Momenta application. Sanofi is suing FDA in a bid to reverse the ANDA approval, although a judge rejected the innovator's request for a preliminary injunction (Also see "Court Backs FDA Rationale For Approving Generic Lovenox" - Pink Sheet, 26 August, 2010.).

Amphastar also gone to court seeking to force FDA to approve its enoxaparin ANDA (Also see "Amphastar Seeks Court Order Requiring FDA To Approve Its Enoxaparin ANDA" - Pink Sheet, 3 January, 2011.).

-Sue Sutter (s.sutter@elsevier.com)

New Delay For Teva's Generic Lovenox Bodes Well For Sandoz/Momenta Sales

More from Archive

More from Pink Sheet