Teva sues FDA for changing ‘first applicant’ definition for generics

Generics/General | Posted 09/11/2018 post-comment0 Post your comment

There is yet another twist in the tale of generics of Allergan’s blockbuster dry eye treatment, Restasis (cyclosporine ophthalmic emulsion). The latest development has Israeli generics giant Teva Pharmaceutical Industries (Teva) suing the US Food and Drug Administration (FDA) for changing its policy on eligibility for 180-day marketing exclusivity for generics.

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In the US, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand-name drug upon which the generic is based. This can be done by filing a Paragraph IV ‘certification’ that the patent for the brand-name drug is invalid, unenforceable, or will not be infringed by the generic drug product. The first company to submit an abbreviated new drug application (ANDA) to FDA containing a Paragraph IV certification has the exclusive right to market the generic drug for 180 days [1].

On 18 August 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law [2]. This renewal of the act created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies.

Under the Hatch-Waxman Act enacted in 1984, the first generic drug applicant to file an ANDA containing a Paragraph IV certification to a patent was eligible for 180 days of exclusivity. The definition was revised slightly in 2003 to include that the application must be ‘substantially complete’ and the term ‘First Applicant’ was applied. However, in July 2018, in a letter regarding Suboxone generics, the FDA ruled that ANDA applicants can qualify for 180-day exclusivity whether or not they provide a Paragraph IV certification.

This led Teva to file a Complaint and Motion for Preliminary Injunction on 17 October 2018 in the US District Court for Columbia. In its lawsuits Teva alleges that FDA’s interpretation of the definition of ‘First Applicant’ is unlawful. The company also asserts that it was the first generic applicant that complied with the Hatch-Waxman Act’s requirements for challenging at least one of the patents covering Restasis.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA ANDAs containing paragraph IV patent certifications []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Application fees increase for prescription drugs []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from:

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Source: FDA Law Blog, Teva, US FDA

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