How long is data exclusivity?

While innovator firms run their own clinical trials to gain marketing approval, generic manufacturers typically rely on the innovator’s clinical trials for the same approval. Data exclusivity rules keep generic firms from relying on that data for 5 to 12 years, depending on the specific law.

What is regulatory data exclusivity?

“Data exclusivity” refers to the period in which certain information that has been provided to a regulatory authority for the purposes of obtaining regulatory approval, remains confidential, or cannot be relied upon by the regulatory authority or a third party in order to obtain regulatory approval of a follow-on …

What is data and market exclusivity?

Data exclusivity (regulatory data protection) and related market exclusivity are rights attaching to certain pharmaceutical products; additional to and independent of patent protection.

What is FDA market exclusivity?

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.

What is data exclusivity in Australia?

In Australia, innovators enjoy data exclusivity protection by which certain information provided to the regulatory authority (the Therapeutic Goods Administration of Australia (TGA)) for the purposes of obtaining regulatory approval for prescription medicine remains confidential and cannot be accessed or referenced by a third party.

What is the 5 year data exclusivity period?

This data exclusivity period runs for 5 years, beginning on the date of marketing approval. It applies in relation to therapeutic goods which contain a “new active component” which has not been previously included in the Australian Register of Therapeutic Goods (ARTG).

What is the data exclusivity period under the TPP?

Under Article 18.52 of the TPP, all of these signatory countries will be held to an eight-year period of data exclusivity, or a five-year period accompanied by “other measures” and recognition “that market circumstances also contribute to effective market protection.”

Can a third party seek regulatory approval during the data exclusivity period?

Under the Australian provisions, it is still possible for a third party to seek regulatory approval during the data exclusivity period. However, the applicant cannot rely on or reference any confidential information provided to the TGA by the first applicant in support of their subsequent request for approval.