Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman amendments, was enacted in 1984 to streamline the approval process for generic drugs. Under this law, generic drug manufacturers can file an ANDA to seek approval for a generic version of a previously approved brand-name drug, also known as the RLD.
While an ANDA product is generally expected to be identical to the RLD, there are certain situations where differences may be allowed. These differences are governed by 505(j) of the FD&C Act and can be requested through a process called an ANDA suitability petition.
Suitability petition allows the following differences in an ANDA:
1) A different active ingredient in a combination product in which the other active ingredients match those of the RLD.
2) A different route of administration.
3) A different dosage form.
4) A different strength.
Please note that not all differences can be approved through an ANDA suitability petition. The petition can only be used for changes that do not require additional clinical evidence for efficacy and safety.
The petitioner must file a request with the FDA, which is then made available to the public through a public docket. Interested parties can provide input on the petition, and the FDA’s OGD and CDER will review the petition before making a decision.
If the petition is approved, the generic drug manufacturer can then use the approval to file an ANDA for the proposed changes. However, it should be noted that once a suitability petition is approved, any other company can also use the approval to file for the same change. This can result in multiple generic versions of the same drug being approved with the same differences.
505(b)(2) pathway was created by the FDA to offer an alternative route for drug approval. This pathway allows for the submission of a NDA that relies in part on the FDA’s findings for a previously approved drug, also known as RLD.
This is particularly beneficial for drugs that offer significant improvements over the RLD, such as new indications, changes in dosage form, strength, formulation, dosing regimen, or route of administration, new combination products, prodrugs, new active ingredients (drug has been previously approved in another country but not in the US) as long as the safety and efficacy of the can be demonstrated through the existing data for the RLD.
Read Also:
- Patents and Exclusivities | Differences and Importance
- CBE-0, CBE-30 and PAS Submission in ANDA
- Difference Between 505(b)(1) and 505 (b)(2)
Resource Person: Bharathi Kodali