What does the Hatch-Waxman Act do?

Broadly speaking, the Hatch-Waxman Act provides incentives for generic drug companies to challenge patents owned by innovators, and it gives generics a research exemption that allows them to develop generic drugs while patents for the brand are still in force — without being liable for infringement.

What is the Hatch-Waxman Act also known as?

The “Drug Price Competition and Patent Term Restoration Act of 1984,” also known as the Hatch-Waxman Amendments, established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C …

What is a 505 b )( 2 application?

A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for …

What is Hatch Waxman litigation?

The Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 to streamline the process for generic pharmaceutical approvals and preserve incentives for innovation, including the creation of a procedure for patent …

Where is Hatch Waxman codified?

The Hatch-Waxman Act created a statutory exemption from certain claims of patent infringement. As codified in 35 U.S.C. §271(e)(1), this provision mandates: “It shall not be an infringement to make, use, offer to sell, or sell within the United States a patented invention …

What are the patent certifications under Hatch-Waxman Act?

In the US, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based.

What is a paragraph IV certification created by the Hatch-Waxman Act?

Paragraph IV Patent Certifications. Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

What is an ANDA vs NDA?

An Abbreviated New Drug Application (ANDA) contains data which is submitted to the FDA for the review and potential approval of a generic drug product whereas a New Drug Application (NDA) is the application through which sponsors formally propose the approval of a new pharmaceutical drug.

What is an NDA filing?

NDA Filing means a New Drug Application filed as a result of activities under this Agreement with the FDA, or the equivalent application to the equivalent agency in any other country of the Territory, the filing of which is necessary to market and sell a Product, including all amendments and supplements to any of the …

What is hybrid NDA?

Hybrid Medicines. and 505(b)(2) NDA. Approval Pathways. Hybrid medicines are drugs based on a generic molecule and have a different route of administration, format, strength, or indication from the original reference product.

What is the Hatch-Waxman Act and what are the requirements?

Accordingly, the Hatch-Waxman Act requires ANDA applicants to make a certification regarding each of the patents listed in the Orange Book for the innovator product.

Do I need a Hatch-Waxman statement for an ANDA?

However, the Hatch-Waxman Act also permits ANDA applicants to avoid having to make patent certifications if the applicant does not pursue approval for the aspect of the innovator product that is covered by a listed patent. In this case, the ANDA applicant would make a Section VIII Statement.

What are the changes to Hatch-Waxman?

Key MMA Changes to Hatch-Waxman Pre-MMA: Patent-by-Patent. •Separate exclusivity periods would be awarded for each patent. •Complicated landscape. Post-MMA: Product-by-Product. •This means there should only be one period of generic drug exclusivity (though perhaps shared by more than one applicant).

How long does Hatch Waxman exclusivity last?

•study resulting in 6 months of ped exclusivity may also result in 3 year Hatch Waxman exclusivity •results in 6 months if sponsor “fairly responds” to Written Request •attaches to all drug products that contain the same active moeity provided they are held by the same sponsor •Is Not: