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Statistical Methods for Assessment of Complex Generic Drugs
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
In 1984, the US FDA issued the Drug Price Competition and Patent Term Restoration Act, which assumes that BE is an effective surrogate for safety and efficacy (Kanfer & Shargel, 2007). Based on this act, the current approval pathway of generic drugs is established. Generic drugs could be approved based on evidence of average BE in drug absorption through the conduct of bioavailability and BE studies. However, for some drugs with one or more features that make them difficult to be genericized, the traditional one-size-fits-all approach may not be adequate or appropriate. As stated in the GDUFA commitment letter (Choi et al., 2018; GDUFA, 2016), complex scenarios can be classified into five categories: Complex active ingredients;Complex formulations;Complex dosage forms;Complex routes of delivery;Complex drug-device combinations.
Regulatory Standards for Approval of Topical Dermatological Drug Products
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
April C. Braddy, Dale P. Conner
Since 1984, generic drug products have been approved by the U.S. FDA on the basis of an ANDA submission. The ANDA submission contains an applicant’s proposal for a generic version of the RLD product. The basis of approval of generic drug products is the Drug-Price Competition and Patent Term Restoration Act of 1984, also known as the Waxman-Hatch Act (US Code, 1984). This Act modified the FFD&C Act. ANDA submissions for generic drug products generally do not require submission of costly animal and clinical studies. According to 505 (j) of the FFD&C Act, a generic drug product must be bioequivalent to the RLD product. In addition to demonstrating BE, the generic drug product must also be pharmaceutically equivalent. Pharmaceutical equivalence is based on the generic drug product containing the same amount of the API in the same dosage form as the RLD drug product and meeting compendial or other applicable standards (i.e., strength, quality, purity and identity). In vitro or in vivo BE studies serve to confirm that a generic drug product has equivalent formulation performance and safety, since efficacy has already been previously established through the NDA approval process.
Generics and Biosimilars
Published in Shein-Chung Chow, Innovative Statistics in Regulatory Science, 2019
In the United States, for traditional chemical (small molecule) drug products, when an innovative (brand-name) drug product is going off patent, pharmaceutical and/or generic companies may file an abbreviated new drug application (ANDA) for approval of generic copies of the brand-name drug product. In 1984, the FDA was authorized to approve generic drug products under the Drug Price Competition and Patent Term Restoration Act, which is also known as the Hatch-Waxman Act. For approval of small molecule generic drug products, the FDA requires that evidence of average bioavailability, in terms of the rate and extent of drug absorption, be provided. The assessment of bioequivalence as a surrogate endpoint for quantitative evaluation of drug safety and efficacy is based on the Fundamental Bioequivalence Assumption that if two drug products are shown to be bioequivalent in average bioavailability, it is assumed that they will reach the same therapeutic effect or they are therapeutically equivalent and hence can be used interchangeably. Under the Fundamental Bioequivalence Assumption, regulatory requirements, study design, criteria, and statistical methods for assessment of bioequivalence have been well established (see, e.g., Schuirmann, 1987; EMEA, 2001; FDA 2001, 2003a, 2003b; WHO, 2005; Chow and Liu, 2008).
Exploring drug patent linkage and the first ANDA litigation in China
Published in Expert Opinion on Therapeutic Patents, 2022
Drug patent linkage is a mechanism for the early resolution of patent disputes in the pharmaceutical field. The U.S. was the first country to adopt the mechanism [1]. Patent linkage was established in the U.S. under the ‘Drug Price Competition and Patent Term Restoration Act,’ which is generally termed as ‘Hatch-Waxman Act’ of 1984, to balance the benefits between New Drug Application (NDA) holders and Abbreviated New Drug Application (ANDA) filers [2]. There are four important components in the U.S. patent linkage system: patent listing in the Orange Book (which identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration [FDA]), patent certification by a generic drug applicant, stay of generic approval, and first generic exclusivity. The U.S. patent linkage system, which has been running for nearly forty years and has experienced several reforms [3], has played an important role in encouraging generic drug applications and reducing drug prices. ‘Trade-Related Aspects of Intellectual Property Rights’ (TRIPS) provided flexible measures to protect public health and increase access to medicine [4]. Provisions related to pharmaceutical products, including patent linkage, were introduced by trade agreements [5]. Such agreements with the U.S. have introduced patent linkage in several countries [6], which is considered a ‘Plus’ provision to the TRIPS agreement [7]. Patent linkage has been established in more than 20 countries and regions [8].
Listing of drug delivery device patents in the USFDA’s Orange Book: What the patent drafters can learn from Lantus® soloSTAR® device lawsuit?
Published in Expert Opinion on Therapeutic Patents, 2021
The United States Food and Drug Administration (USFDA) maintains a publication, known as the Orange Book (OB), which includes a list patents related to all New Drug Application (NDA) products [1]. These patents, known as OB-listed patents, are submitted by the NDA holders to the USFDA, which consequently lists them in the OB. A major purpose of the OB listing mechanism is to acquaint the Abbreviated NDA (ANDA) filers with the patent rights of the NDA holder in relation to the approved NDA product. Accordingly, the filing of ANDA application referring to the aforementioned NDA product as “reference listed drug” requires appropriate patent certifications in relation to each of the OB listed patents [2]. Among the various patent certifications, the Paragraph-IV certification is of paramount importance as only this can lead to a cascade of events including, initiation of patent litigation; a 30-month automatic stay of marketing approval of the ANDA product; early market entry of the generic product; and 180-day exclusivity for the first ANDA filer(s). This mechanism, called as “drug-patent linkage’, is enforced in the US by the ‘The Drug Price Competition and Patent Term Restoration Act of 1984ʹ, commonly known as the Hatch-Waxman (HW) Act [2].
Continuing trends in U.S. brand-name and generic drug competition
Published in Journal of Medical Economics, 2021
Henry Grabowski, Genia Long, Richard Mortimer, Mehmet Bilginsoy
Since the passage in 1984 of the Hatch–Waxman Act (formally, the Drug Price Competition and Patent Term Restoration Act), U.S. pharmaceutical competition has continued to evolve, with increases in rates of both generic drug penetration and patent litigation over the past two decades. The Hatch-Waxman Act increased generic drug competition for small-molecule drugs, while also creating incentives for continued medical innovation and new drug development. Patent challenges by generic drug manufacturers have become commonplace, and brand-name drugs often experience rapid sales decline following generic drug market entry. As a result, new brand-name drugs typically rely on U.S. sales during a market exclusivity period (MEP), or the time between the market launch of a brand-name drug and the market launch of its first generic, to generate profits and fund future investment.