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This document is a notice from the FDA amending the regulatory review period determination for the device VITREON, regarding its patent extension related to its investigational new drug application.

How to fill out determination of regulatory review

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

1. Begin by obtaining the FDA Form 3542 which is used to request a Determination of Regulatory Review Period.
2. Provide the title of the drug or biologic in question, in this case, VITREON.
3. Fill out Section A with the relevant approval date from the FDA.
4. Indicate the patent number related to VITREON in the designated section.
5. Provide all dates of major regulatory milestones for VITREON.
6. Ensure that you attach all necessary documents supporting the review period claims.
7. Review the completed form for accuracy and compliance with the FDA guidelines.
8. Submit the form along with any required fees to the pertinent FDA department.

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

1. Patent holders of VITREON seeking an extension of their patent protection due to regulatory review periods.
2. Companies involved in the production or commercialization of VITREON.
3. Legal representatives managing intellectual property matters related to VITREON.
4. Regulatory affairs professionals needing to comply with patent extension procedures.

People Also Ask about

What is patent term restoration PTR?

Patent Term Restoration (PTR) The extension compensates for the time lost during the regulatory review process. For example, if a pharmaceutical company develops a new drug and receives approval from the NMPA, it can apply for a PTR to extend the patent term.

What is the cost of patent restoration?

For a small entity – INR 6,000. For anyone other than small entity – INR 12,000.

What are the rules for patent extension?

In all cases, the total patent life for the product with the patent extension cannot exceed 14 years from the product's approval date, or in other words, 14 years of potential marketing time. If the patent life of the product after approval has 14 or more years, the product would not be eligible for patent extension.

What is a patent term restoration?

Most new drugs receive a patent term restoration (PTR) extension. Patents with PTR commonly expire more than 12 years after marketing approval. Patents with PTR typically protect the active ingredients of products. Generic entry typically occurs upon expiry of PTRs or afterwards, but not before.

What is patent restoration?

What does Restoration of patent mean? A patent is lapsed where the renewal fees have not been paid. It is possible to restore a patent after it has lapsed provided the application to restore is made in time. An application for restoration is only necessary if the grace period of six month has expired.

What is patent term restoration for top selling drugs in the United States?

Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost to clinical testing and regulatory review, current law provides patent term restoration (PTR) of up to 5 years.

For pdfFiller’s FAQs

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

The Determination of Regulatory Review Period for Purposes of Patent Extension for VITREON refers to the process of specifying the time period during which a drug was reviewed by the regulatory body, which can affect the eligibility and duration of patent extensions for the product.

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

The holder of the approved New Drug Application (NDA) for VITREON 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; VITREON; Amendment?

To fill out the Determination of Regulatory Review Period for Purposes of Patent Extension form for VITREON, the applicant must provide accurate dates for the regulatory review period, including submission and approval dates, and ensure all required sections are completed as per FDA guidelines.

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

The purpose of the Determination of Regulatory Review Period for Purposes of Patent Extension for VITREON is to establish the official review timeline that may grant the patent holder extra time to exclusively market their product, thus providing an incentive to develop new pharmaceuticals.

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

The information that must be reported includes the NDA number, the names of the product and its active ingredients, the regulatory review start and end dates, the date of approval, as well as any relevant patent numbers and expiration dates.