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# Sandoz Sues FDA Over Aubagio NCE Status
- URL: https://www.fdaweb.com/sandoz-sues-fda-over-aubagio-nce-status/
- Published: 2021-03-09T12:00:00.000Z
- Updated: 2026-09-14T16:50:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148835

Sandoz has filed suit in DC federal court asking it to overturn FDA’s award of new chemical entity exclusivity to Sanofi Genzyme’s multiple sclerosis drug Aubagio (teriflunomide). The [suit](http://www.fdaweb.com/download.php?file=7005731-0--23929.pdf) also asks the court to order FDA to accept Sandoz’ ANDA for a generic form of Aubagio as of its original 2016 submission date. The company asks the court to resolve the matter quickly to protect what Sandoz says is its entitlement to 180 days of marketing exclusivity based on being the first to file an ANDA for Aubagio.

In its filing, Sandoz says that all parties to the case agree that teriflunomide is the Aubagio active ingredient and Sanofi Genzyme and FDA have admitted that the ingredient was known to the therapeutically active in treating autoimmune diseases like multiple sclerosis long before the Aubagio NDA was submitted to FDA. In fact, the filing says, teriflunomide was approved by FDA for Sanofi Genzyme’s Arava.

“Indeed,” the brief says, “FDA’s review and approval of the Aubagio NDA took barely over one year precisely because (in FDA’s own words) teriflunomide already ‘was well understood’ by the agency and because Arava and Aubagio are for all intents and purposes equivalent to each other.”

Sandoz says that given the undisputed facts, “FDA’s decision to nonetheless deem teriflunomide a new chemical entity eligible for special protection from generic competition conflicts directly with the text of the Federal Food, Drug, and Cosmetic Act, its structure, and FDA’s implementing regulations.”

Sandoz faults FDA for not changing course once Sandoz raised the issue. The company says it first challenged the agency’s exclusivity decision for Aubagio over four years ago and filed a formal dispute resolution request when the agency upheld the award of exclusivity to Aubagio. Although FDA is supposed to respond to formal dispute resolution requests in 30-60 days, Sandoz says, it took 28 months for it to respond to this case and then “did not engage with either the relevant statutory language or the undisputed facts regarding teriflunomide’s established therapeutic effect at the time FDA approved its inclusion in Arava.”

Sandoz says FDA’s exclusivity ruling for Sanofi Genzyme will cost Sandoz well over $100 million in sales if not set aside. It asks the court to move quickly so Sandoz will know whether to prepare for 180 days of marketing exclusivity for its ANDA or for a marketplace with multiple generic entrants arriving at the same time as its product.