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This document provides the FDA's determination of the regulatory review period for the drug FERAHEME, which is used for the treatment of iron deficiency anemia in patients with chronic kidney disease.

How to fill out determination of regulatory review

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

1. Obtain the necessary form for Determination of Regulatory Review Period for Purposes of Patent Extension for FERAHEME.
2. Review the instructions provided with the form carefully.
3. Fill out the applicant's name and address in the designated sections.
4. Indicate the patent number for which the extension is being sought.
5. Specify the submission date of the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
6. Provide details about the approval date of the NDA or ANDA related to FERAHEME.
7. Include the date of the first commercial marketing of the drug in the U.S.
8. Attach any supporting documentation required, such as FDA communication letters.
9. Review all provided information for accuracy before submission.
10. Submit the completed form to the appropriate regulatory body.

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

1. Pharmaceutical companies that have developed FERAHEME and are seeking patent extensions.
2. Manufacturers looking to extend patent protection for their drug products.
3. Legal professionals assisting in patent matters related to FERAHEME.

People Also Ask about

How to calculate patent term extension in the US?

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 an example of a patent term extension?

For example, if an approved drug product which is eligible for the maximum of five years of extension had ten years of original patent term left at the end of its regulatory review period, then only four of the five years could be counted towards extension.

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'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 a patent term extension for biologics?

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.

Can you extend a patent term?

An applicant may not apply for more than four interim extensions and each extension may be for no more than one year. In order to obtain an extension under 35 USC § 156, the applicant must disclose information which indicates that a patent term extension is appropriate for the patent in question.

For pdfFiller’s FAQs

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

The Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME is a legal process that determines the duration of time a new drug or biologic product is reviewed by regulatory agencies before it is approved for marketing. This determination is essential for asserting patent rights and seeking extensions based on the regulatory review period.

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

The applicant or sponsor of the new drug or biologic product is required to file the Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME with the appropriate regulatory authority.

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

To fill out the Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME, applicants must provide detailed information about the product, including the dates of submission, approval, and any applicable regulatory actions. The form typically requires specific details about the product's regulatory history.

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

The purpose of this determination is to calculate the length of the regulatory review period, which impacts the patent term extension available for a product. This extension allows patent holders to recover some of the time lost during the regulatory review process.

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

The information that must be reported includes the name of the product, the dates of application submission and approval, the regulatory actions taken, and any other relevant details that define the product's regulatory review history.