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This document outlines the regulatory review periods for the drug products KRYSTEXXA and LASTACAFT, as determined by the FDA for the purposes of patent extension.

How to fill out determination of regulatory review

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

1. Obtain the Form for Determination of Regulatory Review Period for Purposes of Patent Extension.
2. Identify the patent to which the review period will apply.
3. Gather all relevant dates including the submission date of the New Drug Application (NDA) and the approval date of KRYSTEXXA.
4. Document the duration of the preclinical and clinical study phases relevant to the drug.
5. Calculate the total review period by adding the time taken for the FDA review and any applicable extensions.
6. Fill out the form with all gathered information accurately.
7. Submit the completed form to the appropriate regulatory body for review.

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

1. Patent holders of KRYSTEXXA seeking patent term extension.
2. Pharmaceutical companies involved in the research and development of KRYSTEXXA.
3. Legal representatives managing intellectual property for KRYSTEXXA.
4. Investors interested in the patent status and protections for KRYSTEXXA.

People Also Ask about

What's the time frame for a patent extension?

How many months can a patent response be extended? If more time is needed to respond to a substantive Office Action, a maximum three-month extension of time may be requested giving the applicant a maximum total of six months from the date of the Office Action.

What is the rule 7 of the patent law?

Explanation - Where a startup or small entity, having filed an application for a patent, ceases to be a startup or small entity due to the lapse of the period during which it is recognized by the competent authority, or its turnover subsequently crosses the financial threshold limit as notified by the competent

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.

Can a US patent be extended beyond 20 years?

Patents in the U.S. typically have a set lifespan that cannot be extended under normal circumstances. For utility patents, which protect the functional aspects of an invention, the duration is 20 years from the filing date.

What is a patent term extension drug?

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.

Who is eligible for patent term extension?

(a) A patent is eligible for extension of the patent term if the patent claims a product as defined in paragraph (b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a

For pdfFiller’s FAQs

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

The Determination of Regulatory Review Period for Purposes of Patent Extension refers to the process used to calculate the length of time a drug, specifically KRYSTEXXA, was under regulatory review by the FDA. This period can affect the extent to which patent extensions are granted.

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

The applicant or sponsor of the drug KRYSTEXXA is required to file the Determination of Regulatory Review Period. This typically includes the company that holds the patent and is seeking an extension.

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

To fill out the Determination of Regulatory Review Period for KRYSTEXXA, the filing party must complete the designated form provided by the FDA, providing relevant information about the drug’s approval dates, any correspondence with the FDA, and any additional data that may affect the review period calculation.

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

The purpose of the Determination of Regulatory Review Period is to establish the applicable review period that will be used to potentially extend the patent protection for KRYSTEXXA, thereby allowing the patent holder to maintain exclusive rights to market the drug for a longer time.

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

The information required includes the drug's approval date, any relevant regulatory submissions, the timeline of activities related to the drug’s application, and any communications with the FDA that are relevant to the review period.