In the drug business, market exclusivity is king. Every branded business model is built on it. But what happens if your brand doesn't have exclusive market access? If you're Sanofi preparing to launch over-the-counter Nasacort, you sue the FDA.
As the FDA Law Blog reports, Sanofi ($SNY) filed a lawsuit to block the FDA's public posting of the official labeling on Nasacort Allergy 24 HR, its new OTC version of the nasal spray. Approved by the agency last month, the product is expected to launch in the U.S. early next year. And until that launch, Sanofi contends, the label is essentially a trade secret.
Though Sanofi won the agency's approval for the product, it didn't win three-year exclusive access to the OTC market as hoped. So, generics could hit as soon as they, too, win FDA approval. But as the FDA Law Blog notes, those generics have to carry labels identical to the branded version. If Sanofi can keep the label out of the public eye until OTC Nasacort hits store shelves, then makers of generic versions will face at least some delay in getting their copies to market.
So far, the FDA hasn't posted the label and accompanying literature on its website. But four generics makers have filed Freedom of Information Act requests for the label. Sanofi claims that the label falls under FOIA's trade-secret exemption, and it's asking the court to keep the label private on that basis. If not, then Sanofi wants the court to block the FDA's label release until Sanofi's Chattem unit rolls out the product.
Other drugmakers have tried to stave off generic competition based on label exclusivity. AstraZeneca ($AZN) sued the FDA to block generic versions of Seroquel, claiming that safety data on its label was proprietary. Because that safety data had to be included on generic labels, copycat versions shouldn't be allowed, the company claimed. The court didn't agree, and Seroquel copies rolled onto the market as scheduled.
- read the FDA Law Blog's post
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