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This document provides the FDA's determination regarding the regulatory review period for the drug LATUDA, which is necessary for patent extension purposes.

How to fill out determination of regulatory review

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

1. Obtain the FDA Form for Determination of Regulatory Review Period.
2. Identify the patent corresponding to LATUDA (Cariprazine).
3. Gather all relevant information regarding the submission dates of the New Drug Application (NDA) including the date of submission, approval date, and any major amendments.
4. Review the regulations pertaining to the regulatory review period for patent extensions to ensure compliance.
5. Complete the form by filling in the required sections with the collected data.
6. Double-check all provided information for accuracy and completeness.
7. Submit the completed form to the appropriate patent office or regulatory authority.

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

1. Pharmaceutical companies that hold the patent for LATUDA.
2. Regulatory affairs specialists involved in patent extension applications.
3. Legal teams focusing on intellectual property rights associated with LATUDA.

People Also Ask about

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

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

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 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 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.

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.

For pdfFiller’s FAQs

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

It is a process that defines the duration of the regulatory review period for the drug LATUDA, which is essential for determining eligibility for a patent extension.

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

The manufacturer of LATUDA, or any patent holder that believes the regulatory review period should be formally determined for the purposes of seeking a patent extension.

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

To fill it out, the applicant needs to provide detailed information about the drug, including the NDA number, dates of approval, and any prior periods of review for accurate determination.

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

The purpose is to establish a clear timeline of the regulatory review process that can be used to calculate potential patent extensions, thereby protecting intellectual property rights.

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

The report must include the New Drug Application (NDA) number, approval and marketing dates, and any relevant correspondence with regulatory authorities pertaining to LATUDA.