Home / Policies & Legislation / US FDA acts to improve transparency and predictability for new generics applications

US FDA acts to improve transparency and predictability for new generics applications Posted 26/07/2019

On 18 June 2019, the US Food and Drug Administration (FDA) released a ‘Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high quality, lower cost generic drugs’. Here, the agency outlines that, to facilitate American patients’ access to lower-cost generic medicines, they are taking steps to enhance and streamline the development and approval process of high quality generic drugs.

In 2017, 90% of the US drugs market was made up of generic drugs. In 2017 and 2018, FDA approved or tentatively approved over 2,000 generic drug applications. As such, the US is one of the most effective generics markets in the world. This competitive generics market, that has driven down drug product prices and improved accessibility and affordability for patients, has been created with the help of FDA actions. The steps that the agency has taken in recent years include the support of complex generic drug development and application review; prioritization of the review of certain generics; and publication of a list of off-patent, off-exclusivity brand drugs.

In their June 2019 statement, FDA outlines that they will do more to improve the availability of generic drugs and allow the further development and maintenance of a stable and competitive generics market. They plan to reduce approval times and enhance the efficiency of some aspects of the submission process for generic drug applicants. They also want to provide the industry with greater transparency in order to improve the certainty of the timing of market entry and allow for more informed decisions on how industry can prioritize resources. All this will be done while ensuring that generics continue to meet FDA’s approval standards and are manufactured under their rigorous quality standards.

FDA has identified that to increase investment in generic drug development, applicants need to be able to predict when a product might receive final approval. This allows applicants to plan when to begin marketing and allow timelier access to medicines for consumers. To facilitate this, the agency has now enhanced one of their most viewed databases, the Paragraph IV Patent Certifications List, which ‘provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity)’. In some cases, generic drug applicants provide a “Paragraph IV Certification” as part of their abbreviated new drug application (ANDA) [1], if they wish to seek FDA approval to market a generic drug before the expiration of a patent for the corresponding brand drug. This certification is a statement asserting that the patent is invalid, unenforceable or will not be infringed by that specific generic drug product.

The enhancements include the addition of information about existing drug products, including the status of any 180-day exclusivity decisions for individual drug products, and information on the dates of first approval, marketing status and expiration dates of blocking patents. The availability of this information is likely to help subsequent generic drug applicants determine when their products can be approved and marketed. Also, with the new data available, generic drug applicants can make more informed business decisions about which specific generic drug applications are more likely to be approved sooner. FDA believes that the availability of this data may provide more public transparency into instances in which FDA approves an ANDA with exclusivity, but the generic drug product is not marketed for an extended time. This will enable ‘gaming’ tactics in the generics market to be identified more easily.

In addition, FDA has decided to announce the number of applicants that are potentially eligible for 180-day exclusivity. This will inform other generics manufacturers’ decisions on whether to develop a generic drug for that product. Once the exclusivity period has expired or eligibility relinquished/forfeited by the first generics applicant, other generic drugs that meet the approval requirements can enter the market. FDA data shows that significant price decreases occur when there are at least three generic drugs on the market.

In some, uncommon circumstances, a generic drug manufacturer previously granted final approval for a specific product may be court ordered to cease marketing due to patent infringement. To help ensure there’s a transparent process for handling such cases, FDA will provide clarity to industry in the near future.

FDA states that, under their Drug Competition Action Plan [2], they continue to look to provide greater clarity and transparency to generic drug applicants looking to bring their products to market. They plan to publish additional guidances and take additional policy steps to assist generic drug applicants to improve drug access.

Related articles
US government advances five bills to increase generics competition

FDA issues new guidance for accelerated pathway for generics

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on tentatively approved ANDAs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. FDA forms working group to increase generics competition. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Comments (0)