FDA opens more information on first generic anda to encourage generic drug development

In order to speed up the listing of generic drugs, FDA issued the drug price competition and patent term Restoration Act (the famous hatch Waxman act) in 1984, which provides a possibility for generic drugs to be listed before the expiration of the original patent protection The act encourages generic companies to challenge the monopoly of the original research drug market, and stipulates several situations in which patent declaration is required in the Anda materials, including the fourth case (P 4) The generic applicant declares that the patent of an original research drug listed in the FDA orange peel book is invalid, or the production, use and sale of the generic drug submitted by the applicant will not infringe the patent of the original research drug, that is, the PIV patent challenge The first anda generic drug that launched the patent challenge of PIV and successfully went on the market can obtain a 180 day market monopoly period FDA has always been committed to improving the communication efficiency with generic drug applicants, especially before generic drug manufacturers submit a brief new drug application anda, FDA hopes to have as much information as possible for reference to applicants Therefore, FDA will timely publish the adaptability petitions initiated by generic companies and the P IV patent challenges list on its website Previously, the information provided by the PIV patent challenge case was very limited, only the drug name (dosage form, specification) and the filing date of the first full anda containing the PIV challenge statement However, it is often missed that an application for generic drugs with a 180 day exclusive period may be obtained earlier than this anda Now, the PIV patent challenge cases on the FDA website have more information, including the number of first generic anda for the same original research drug, the granting status of 180 day market monopoly period for specific generic drugs, the first approval date, the listing status, the expiration time of the original research patent, etc These information can provide a more comprehensive reference for the decision-making of generic pharmaceutical manufacturers Under the design of American generic market competition system, the 180 day market monopoly period is very important Generic companies will rush to submit anda applications containing the PIV challenge statement on the day when the new drugs have been on the market for four years, so as to enjoy or share the 180 day market monopoly period If the PIV patent challenge is not initiated, it can only be submitted to anda after the new drug has been listed for 5 years At that time, the market has been basically divided by the first imitation and the original research, and the market opportunities are limited FDA officials said: these public data will improve the transparency of information available to the public For example, the Anda of a certain variety has obtained the market exclusive qualification for 180 days, but the generic applicant may not be sold in the market for other reasons In addition, the information we publicized this time also includes the potential amount of Anda that can share the market monopoly period of 180 days This data is actually a signal that other generic pharmaceutical enterprises should not set up projects to develop this product Since June 18, the Anda information containing the PIV patent challenge will be more fully disclosed by FDA This time, FDA released more information on PIV patent challenge cases, reflecting FDA's attention to drug market competition Generic companies will adjust their decision-making of generic drug projects according to the number of "first generic" anda For example, when they see that the number of first generic anda of a certain variety is not as much as they think, they will seize the time to declare anda earlier 180 days later In addition, FDA has also taken actions to crack down on the original drug research enterprises' malicious efforts to curb the competition of generic drugs It has published a series of original drug research companies that refuse the generic drug companies to purchase their products as reference preparations, released a list of non competitive original drug research companies that have passed the patent period, and accelerated the Anda with fewer than three applicants on the list The withdrawal of these actions is also the credit of Scott Gottlieb, former director of the FDA.