Which Path Should Your Generic Drug Application Take?

Generic drug makers are getting help with deciding the type of abbreviated application to submit for a product’s approval.

Food and Drug Administration draft guidance released Oct. 12 can help manufacturers determine whether to submit an abbreviated new drug application (ANDA) or a 505(b)(2) application. ANDAs are used for generic drug approvals, while the 505(b)(2) application is a special subset of new drug application (NDA). NDAs are used to obtain approval of new branded drug products.

A 505(b)(2) application is an NDA for a drug product that differs slightly from the reference-listed (brand) drug. For example, the new product might have a different route of administration. While 505(b)(2) applications require less scientific information than standard NDAs, they require more information than ANDAs, which have to demonstrate only that the generic drug is bioequivalent to the brand drug.

The advantage of an ANDA is that the generic product can be automatically substituted for the brand product, which isn’t usually the case with 505(b)(2) products. But 505(b)(2) products come with certain patent protections and are eligible for certain exclusivity periods.

Jonathan J. Darrow, an instructor of medicine at Harvard Medical School, told me the 505(b)(2) pathway “can be used for drugs that are less similar to existing drugs but that still share certain characteristics” and aren’t necessarily bioequivalent to the reference-listed drug. He said 505(b)(2) applications require more data, time, and cost than ANDAs.

However, an advantage of 505(b)(2) applications is that manufacturers whose products are approved under this pathway can list their own patent in the FDA’s Orange Book, thereby blocking competitors from copying their product, Gaby L. Longsworth, a patent attorney with Sterne, Kessler, Goldstein & Fox in Washington, told me. The Orange Book is a listing of patents brand-name manufacturers claim cover their drug products.

Also, products approved under a 505(b)(2) application are eligible for either five years of new chemical entity exclusivity or three years of new product exclusivity, depending upon the product, Longsworth said. This differs from ANDAs, which only provide 180 days of exclusivity for the first generic version of an approved brand drug.

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