Examples of ANDA filer in a sentence
An ANDA filer is able to adopt the safety and efficacy studies that the FDA previously approved in connection with a bioequivalent brand-name drug’s New Drug Application (“NDA”).
In addition, the Committee determined that the ANDA filer should produce its Abbreviated New Drug Application or New Drug Application shortly after filing an answer or motion as this is a fundamental element of the Hatch-Waxman action.
It was also recommended that the ANDA filer be required to advise the Food and Drug Administration (“FDA”) of any motion for injunctive relief and supply the parties with relevant communications with the FDA which concern the subject matter filed in the District Court.
Finally, Actavis held that even in a case involving a patent settlement that includes a “large and unexplained” payment from the patentee to the ANDA filer, the challenger “must prove its case as in other rule-of-reason cases,” and only those patent settlements that actually carry “significant anticompetitive effects” will violate that standard.
The high profit margins on brand name drugs, and the predictable effects of generic entry – sales switch quickly from the brand to the generic – virtually assure that a brand name manufacturer will sue the ANDA filer in order to delay final FDA approval of an ANDA.
This statutory provision, added to the Hatch-Waxman Act by the MMA, states that the first Paragraph IV ANDA filer forfeits 180-day exclusivity if “[a]ll of the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired.”334 FDA has recently interpreted this provision in light of the Sebelius decision, concluding that patent expiration for nonpayment of fees does not affect a first ANDA filer’s eligibility for 180-day exclusivity.
Moreover, Congress required the ANDA filer to provide prompt notice to the relevant patent owners (and NDA holder), 21 U.S.C. § 355(j)(2)(B), and for the patent owners to bring suit within 45 days to obtain a 30-month delay in any effective date of approval for the ANDA, § 355(j)(5)(B)(iii).
Because Glenmark was the first ANDA filer, its agreement not to launch generic Zetia until December 2016 created a competition bottleneck wherein no other generic company could market a generic Zetia product until 180 days after Glenmark launched its generic product.
Until the court issues a decision finding the patent invalid or not infringed or until 30 months (or longer if an NCE) has passed, the FDA may grant “tentative approval” to the ANDA filer, recognizing that the ANDA is approvable, but cannot grant final approval, which would allow the generic manufacturer to market its product.
In this case, the ANDA filer submits a Paragraph IV or “P.IV” certification.