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Notice detailing the FDA's determination of the regulatory review period for the drug PROLIA, necessary for patent extension applications.

How to fill out determination of regulatory review

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

1. Obtain the official form for Determination of Regulatory Review Period for Purposes of Patent Extension.
2. Fill in the applicant's name and contact information in the designated fields.
3. Provide the name of the drug, PROLIA, in the appropriate section.
4. Indicate the date of the first commercial marketing of PROLIA.
5. Identify the regulatory agency involved in the review process.
6. Clearly state the relevant regulatory review period dates.
7. Attach supporting documents that verify the dates and information provided.
8. Review the completed form for accuracy and completeness.
9. Submit the form to the appropriate regulatory body as instructed.

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

1. Pharmaceutical companies seeking to extend the patent protection for PROLIA.
2. Legal professionals involved in pharmaceutical patent law.
3. Regulatory affairs specialists assisting with patent extensions.

People Also Ask about

Can a patent term be extended?

The time period for a patent can only be extended by following conventional and constitutional laws that explicitly or implicitly allow for an extension, for a maximum of five years.

Does the patent for biologics expire?

A significant number of biologic drugs are expected to lose patent protection by 2030, creating a substantial opportunity for biosimilar manufacturers. The adoption of biosimilars is increasing due to their potential to transform expensive treatments into more accessible and affordable ones.

What is 156 patent term extension?

156 enables the owners of patents that claim certain human drug products, medical device products, animal drug products, veterinary biological products, and food or color additive products to restore to the terms of those patents some of the time lost while awaiting premarket Government approval for the products from a

Can you extend a drug patent?

The Drug Price-Patent Term Act allows an extension for qualifying patents, not to exceed five years.

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.

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'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 pharmaceutical 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.

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.

What is the term extension for pharmaceutical patents?

Section 70 of the Patents Act allows the patentee of a standard patent to apply for an extension of term if certain conditions are satisfied, namely: The patent must relate to a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology.

For pdfFiller’s FAQs

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

The Determination of Regulatory Review Period for Purposes of Patent Extension for PROLIA is a formal process that establishes the time period during which the FDA reviews the application for the drug. This period is essential for determining eligibility for patent extension, which can provide additional market exclusivity.

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

The sponsor of the drug application, typically the pharmaceutical company that holds the patent for PROLIA, 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; PROLIA?

To fill out the Determination of Regulatory Review Period, the applicant must provide detailed information regarding the regulatory submission dates, the submission type, and any relevant correspondence with the FDA. It requires accurate documentation of the review timelines.

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

The purpose of this determination is to identify the specific review period during which the FDA evaluated the drug, which is crucial for calculating any potential patent extension that may be granted, thereby affecting the commercial exclusivity of the drug.

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

The information that must be reported includes the dates of submission and approval of the drug application, any significant interactions with the FDA related to the application, and other timelines pertinent to the regulatory review process.