Get the free Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD ...

This document provides a determination by the FDA regarding the regulatory review period for the human drug product VIIBRYD for the purpose of patent term extension.

How to fill out determination of regulatory review

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD

1. Obtain the application for Determination of Regulatory Review Period for Purposes of Patent Extension specific to VIIBRYD.
2. Gather all relevant documentation, including the New Drug Application (NDA) submission dates and any FDA correspondence.
3. Complete the form by providing your NDA number, product name (VIIBRYD), and specific dates related to the regulatory review process.
4. Identify the review period, including the time the application was under review by the FDA.
5. Include any public health submissions or other relevant timelines that may affect the calculation of the review period.
6. Submit the completed application along with any supporting documentation to the relevant patent office.

Who needs Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD?

1. Pharmaceutical companies seeking patent extension for VIIBRYD.
2. Patent attorneys representing the interests of the holder of the patent for VIIBRYD.
3. Regulatory affairs specialists involved in drug approval processes.

People Also Ask about

How long is a drug patent effective once FDA approval is obtained?

Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent. 3.

What is a patent extension?

Patent Term. Extensions. Patent term extensions (PTE) extend the term of a patent covering a pharmaceutical product that undergoes regulatory review in order to obtain marketing authorization. There are two principal types of PTE: patent term restoration and pediatric exclusivity. Patent Term Restoration.

How long is a patent effective for?

How long is a patent valid? Utility and plant patents have a term for up to 20 years from the date the first non-provisional application for patent was filed. A design patent is granted for a term of 15 years from the date of grant.

How to calculate patent term extension?

Calculation of the Length of PTE PTE is the sum of the “testing period” and the “approval period,” less: The number of days which were on or before the patent issued. The number of days during which the applicant did not act with due diligence. One-half the number of days of the testing period after the patent issued.

What is the length of time of a manufacturer's patent once a drug has been approved by the FDA?

The standard patent term for drugs is 20 years from filing, but effective market exclusivity is typically 7-12 years due to development and approval timelines[1][2].

How do I find out when my drug patent expires?

One such source is the FDA's Orange Book for Approved Drug Products with Therapeutic Equivalence Evaluations which includes patent expiration dates, some of which may include periods of exclusivity administered by the FDA that add onto patent term.

Is a patent 10 or 20 years?

Term of protection Once your patent is granted, it will be protected for 20 years from the Date of Filing. Thereafter, the patent is to be maintained yearly, starting from the 5th year.

For pdfFiller’s FAQs

What is Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD?

The Determination of Regulatory Review Period for Purposes of Patent Extension is a formal process that identifies the time frame during which the U.S. Food and Drug Administration (FDA) reviewed the application for a drug, in this case, VIIBRYD, to determine eligibility for patent extension under the Hatch-Waxman Act.

Who is required to file Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD?

The applicant who holds the patent for VIIBRYD or their authorized representative is required to file the Determination of Regulatory Review Period for Purposes of Patent Extension.

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD?

To fill out the Determination of Regulatory Review Period, the applicant must complete the designated form by providing detailed information about the drug, the patent number, the submission dates, and any relevant FDA review timelines.

What is the purpose of Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD?

The purpose of this determination is to officially calculate the regulatory review period that can be used to extend the patent protection for VIIBRYD, thus incentivizing pharmaceutical innovation by compensating for time lost during the approval process.

What information must be reported on Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD?

The information that must be reported includes the patent number, the name of the drug (VIIBRYD), the dates of application submission and approval, as well as any relevant correspondence with the FDA regarding the review process.