The timing of 30‐month stay expirations and generic entry: A cohort study of first generics, 2013–2020

Abstract

Before the first generic version of a drug can be marketed, patent litigation often occurs. The process begins when generic manufacturers notify the FDA of their intent to market a generic copy of a brand-name drug protected by patents, which they allege to be invalid or not infringed (called a Paragraph IV Certification). Assuming the brand-name manufacturer timely responds with litigation, a 30-month stay period is triggered, which bars the FDA from authorizing generic entry until the stay period expires or litigation is resolved in favor of the generic manufacturer. To understand whether 30-month stays delay generic entry, we examined the timing of major legal events leading to generic entry for a cohort of 46 generic drugs, including the timing of Paragraph IV Certification filings, stay period expirations, FDA approvals of generics, and generic product launches. We found Paragraph IV Certifications were filed a median of 5.2 years after the brand drug's FDA approval. There was a median of 3.2 years between the stay period expiration and subsequent generic launch. Because stay periods generally expire well in advance of when generic entry typically occurs, 30-month stays are unlikely to impact the timing of generic entry. To facilitate patent dispute resolution and ensure it does not unduly delay the anticipated launch of generic products, patent litigation should be allowed to start immediately following a brand-name drug's FDA approval.

Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists

“…In the case of inhalers, a recent study found that only 13% of brand-name products in that class approved over the past 35 years faced any Paragraph IV certifications, and the median time from brand-name approval to first Paragraph IV certification was 14.5 years . By contrast, among oral small-molecule drugs, the median time from brand-name approval to first Paragraph IV certification was 5.2 years . One hypothesis for this difference is that device patents on drug-device combinations deter generic manufacturers from seeking approval; another related possibility is that proving bioequivalence for drug-device combinations to earn FDA approval may be challenging as compared with oral formulations and thus attracts fewer potential competitors.…”

Patent and Marketing Exclusivities 101 for Drug Developers

“…To compensate the innovator for the loss of market share, the Act introduced a period of 5 years of data exclusivity, which only applies to an NCE like RRx-001 [ 49 ]. In practice, this period may be extended to up to 7.5 years since it is common for the brand name company to file a patent infringement lawsuit against a generic applicant, once it receives notice of an ANDA submission, triggering a 30-month stay, during which time the FDA cannot approve the ANDA so long as the infringement lawsuit is ongoing or resolved in the brand name company’s favor [ 50 ].…”

Repositioning Generic Drugs: Empirical Findings and Policy Implications

“…22 21 U.S.C. § 355(c)(3)(E)(ii).23Kannappan et al (2021Kannappan et al ( ), pp. 1922Kannappan et al ( -1924 Ibid.25 Directive 2001/83/EC (OJ L 311 p. 67), Art.…”