FDA approves first-time generic Lovenox

Sandoz, the generics division of Novartis, is the first company to receive US approval to market a generic version of the leading hospital-based medication, Lovenox (enoxaparin sodium), the “gold standard” in anti-thrombotic treatment. No sooner did Sandoz begin shipments of the generic version, Sanofi-Aventis, manufacturer of Lovenox, filed a lawsuit to prevent the approval of the generic.  Last year, Lovenox recorded $4.57 billion in sales for Sanofi-Aventis, according to IMS Health. Both the new generic and Lovenox are low-molecular-weight heparin anticoagulants that help prevent deep vein thrombosis.

“Generic enoxaparin has the potential to bring hundreds of millions of dollars of savings to the US healthcare system and in turn, to payors and consumers,” according to Sandoz US.

Trying to protect its widely used branded drug, Sanofi-Aventis is challenging the new generic’s safety and whether FDA failed to ensure that the product has the same active ingredients as Lovenox, a complex mixture of sugar molecules derived from a pig intestine. The drugmaker also claims that FDA approved enoxaparin through an abbreviated new drug application (ANDA) rather than as a completely new drug.  An ANDA application allows for interchangeability of a product without conducting a clinical trial.

“Sanofi-Aventis is concerned by potential implications for patient safety since the product approved today has not been subjected to extensive clinical trials to demonstrate its efficacy and safety as Sanofi-Aventis has done with its product,” said the company in a press release.

FDA requested that Sandoz and its partner, Momenta Pharmaceuticals, develop a robust clinical trial, one not as extensive as that needed for a new product approval. Sandoz underwent a rigorous 5-year FDA approval process for enoxaparin and is confident in the FDA's actions, said the company.

In response to the lawsuit seeking a temporary restraining order, the US District Court for the District of Columbia has set a preliminary injunction hearing for Aug. 17, 2010, which names FDA Commissioner Margaret Hamburg and Health and Human Services Secretary Kathleen Sebelius as defendants.  In the interim, the Court has not restricted sales and shipment of the new generic.

In 2003, Sanofi-Aventis (then Aventis Pharmaceuticals) filed a citizen petition requesting that any generic version of Lovenox be equivalent to the blockbuster branded drug.  It also requested proof that the manufacturing process be equivalent, or show equivalent efficacy and safety in clinical trials.  FDA accepted the first condition, but said it was unnecessary for a company with a generic product for Lovenox to demonstrate the other requests for equivalency.

Sanofi-Aventis anticipates that its core earnings will be flat or drop by 4% this year as a result of the approval of generic enoxaparin. The company had estimated an increase of 2% to 5% for 2010.

A bit of a double-edged sword, Teva, who is concerned that FDA will approve a generic version of its multiple sclerosis drug, Copaxone, is seeking approval for a generic Lovenox.

For more on generic Lovenox, watch for the September issue of

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