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This document provides information regarding the FDA's determination of the regulatory review period for the drug NATROBA, which is used for treating head lice infestations. It details the timelines

How to fill out determination of regulatory review

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

1. Obtain the form for Determination of Regulatory Review Period for Purposes of Patent Extension specific to NATROBA.
2. Review the instructions provided with the form to understand the requirements.
3. Fill in the applicant's information including name and address accurately.
4. Identify and enter the relevant product information related to NATROBA, including the drug's name and the application number.
5. Provide detailed information regarding the approval process, including dates of submission, approval, and any amendments.
6. Calculate the regulatory review period based on the information provided in the application and approvals.
7. Include any supporting documentation, such as correspondence with regulatory authorities.
8. Review the completed form for accuracy and completeness.
9. Submit the form along with any required fees to the appropriate regulatory authority.

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

1. Pharmaceutical companies or patent holders who want to extend the patent term for NATROBA.
2. Legal professionals advising clients on patent law and regulatory compliance related to pharmaceuticals.
3. Researchers and developers involved in the pharmaceutical industry seeking to understand patent extension processes.

People Also Ask about

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 the difference between patent term adjustment and extension?

As inventors seek to capitalize on their inventions, understanding the difference between Patent Term Adjustment (PTA) and Patent Term Extension (PTE) is crucial. PTA compensates for delays in the patent examination process, while PTE compensates for the delays in obtaining regulatory approval.

What is a patent term extension?

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.

How are drug patents extended?

Patent Extension Strategies and Regulatory Exclusivity One primary approach involves leveraging statutory extensions available under the Hatch-Waxman Act, which can provide up to five additional years of patent protection to compensate for time lost during regulatory review1.

What is the patent life of biologics?

The BPCIA provides a 12-year FDA market exclusivity period for a reference branded biologic (the origi- nal biologic drug). This means that the FDA is prevented from approving a biosimilar until 12 years have passed from the date of first approval of the reference product.

How to calculate patent term extension?

Patent Term Extension (PTE) under 35 U.S.C. 156 enables the owners of patent that claim certain human drug products, medical device products, animal drug products, veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket regulatory approvals.

For pdfFiller’s FAQs

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

The Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA refers to the official process that establishes the period during which regulatory review was conducted by the FDA for the drug NATROBA, which may affect the eligibility for patent term extension.

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

The application for the Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA must be filed by the patent holder or their authorized representative.

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

To fill out the Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA, applicants need to complete the designated form provided by the FDA, including information on the patent, product details, and the timeline of regulatory actions taken.

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

The purpose of this determination is to clarify the length of time that the regulatory review process took, which can be used to determine the potential extension of the patent term to compensate for time lost during the approval process.

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

The information that must be reported includes the patent number, the date of approval of the NDA for NATROBA, and the timeline of the regulatory review process, including any relevant actions or correspondence from the FDA.