The U.S. Food and Drug Administration (FDA) this week updated its list of off-patent drugs that have no approved generics, a move designed to encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition.
The list includes approved new drug applications (NDAs) for products that are not protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA).
Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.
Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the agency prior to considering submission of an ANDA.
The Appendix identifies NDA drug products that were removed from Part I or Part II of the list.
The agency says it updates the list every six months to assure continued transparency regarding drug products that potentially can provide significant patient benefit through increased competition.
(Scroll down for Parts I, II, the Appendix, Methodology, and References)
1. The list is based on the Orange Book Data Files, accessed April 13, 2018.
2. The list includes Orange Book-listed drug products. The list generally does not differentiate between different strengths of a given drug product. However, we have included a drug product of multiple strengths on the list if there is not an approved ANDA for one or more of the strengths (even if there is an approved ANDA for one or more other strength). The Agency has identified the corresponding NDA numbers for drug products included on the list to assist applicants with identification of the correct reference listed drug (RLD).
3. A given drug product is included on the list if:
a. There is at least one active and approved NDA for the drug product,2,3 and
b. There are no approved ANDAs for the drug product,4 and
c. There are no unexpired patents or exclusivities listed in the Orange Book for the drug product.5
4. Each drug product and corresponding NDA number is then placed on either Part I or Part II of the list based on the following criteria:
a. Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion with the Agency.
b. Part II identifies drug products for which development and submission of an ANDA could involve potential legal, regulatory or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.
1 FDA notes that the methodology used to compile the original list (posted in June 2017) was updated in December 2017. Under the updated methodology, the list is organized based on drug products, not active ingredients. This means that an active and approved NDA for a particular active ingredient and dosage form will be included on the list if there are no approved ANDAs for at least one drug product for that active ingredient and dosage form approved in the NDA, even if there are approved ANDAs that reference a drug product in a different NDA with the same active ingredient and dosage form.
2 “Active and approved” means that the NDA for the relevant drug product is approved and listed in the Orange Book, and is not identified as a “discontinued” product in the Orange Book. If all approved NDAs for a given drug product are identified as “discontinued” in the Orange Book, that drug product is not included on the list.
3 Drug products with only approved and Orange Book-listed ANDAs but no Orange Book-listed NDAs are not included on the list.4 Drug products with an approved but discontinued ANDA are not included on the list.
5 Drug products that have at least one Orange Book-listed patent or exclusivity are not included on the list.
(Source: U.S. Food and Drug Administration)