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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
Generic drugs are drug products that contain the same Active Pharmaceutical Drug Ingredient (API) as an already marketed brand-name drug. A generic drug should be identical with its brand-name version in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. In many countries, generic drugs are approved through an Abbreviated New Drug Application (ANDA). In other words, generic drug applications are generally not required to demonstrate safety and effectiveness of the generic product through animal and clinical studies like innovative drugs. Instead, a generic drug application should demonstrate that the generic drug would follow a similar behavior in human body as its brand-name counterparts. Bioequivalence (BE) is a primary evidence for the approval of generic drugs. In the US Food and Drug Administration (FDA) guidance, BE is defined as “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study” (US FDA, 2020a).
The Non-Prescription Products – Market-Profits and Public Health in Conflict
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
If the company later wishes to market a different Rx dosage, or formulation of that medication, a full new NDA is required. Conversely, a proposed change might be deemed by FDA to be relatively minor (e.g., a change in an inactive ingredient). In this case, the FDA might require only a supplemental NDA, addressing that limited issue. After a medication is approved for Rx sales, the parent company’s patent will eventually expire. This allows any other company to market the same medication under a different trade name or as a Generic after successfully submitting an Abbreviated NDA (ANDA).
Drug Regulatory Affairs
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
A notice of Claimed Exemption for an Investigational New Drug (IND) must be submitted to the FDA before a new drug may be evaluated in humans. Once a decision has been made to file an IND, the required information and data are assembled, put in the format specified by the regulations, reviewed, and submitted. Before a new drug can be marketed, a New Drug Application (NDA) or an abbreviated application (ANDA) must be filed with the FDA and approved by that agency. The following are other, supplemental types of submissions to FDA that are managed by DRA:
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
This HW Act aims to strike a balance of benefits between the NDA holders (the pioneer pharmaceutical companies) and ANDA filers (the generic pharmaceutical companies). The NDA holders are empowered to trigger a 30-month stay on marketing approval of the ANDA product, a time-period that allows them to prove infringement of their OB-listed patent by the ANDA filers in a Federal Court. However, if prevailed in the patent litigation, the ANDA filer could initiate the commercialization of its generic drug earlier than the usual expiry of the OB-listed patent. Furthermore, the first ANDA filer(s) are incentivized with a period of 180 days of market exclusivity for their generic product. Therefore, the system in whole aims to weed-out the patents, which provide unnecessary monopoly to the NDA holders, thereby providing early access of cheaper alternate and generic versions of the highly priced proprietary products to the public while also safeguarding the interests of those NDA holders, who possess genuine patents.
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
The Hatch-Waxman Act includes a number of provisions designed to facilitate approval by the Food and Drug Administration (FDA) of generic drugs intended for sale in the U.S., thereby encouraging generic drug entry. Among them, the law created an Abbreviated New Drug Application (ANDA) generic drug approval process that substantially shortened the time and reduced the cost associated with a generic drug FDA marketing application. Before the law’s passage, original safety and efficacy data were required for FDA market approval of generic drugs, meaning generic drug manufacturers were faced with the cost of repeating many of the corresponding brand-name drug manufacturers’ clinical trials1. Under the new streamlined ANDA process, generic manufacturers only had to show bioequivalence to the corresponding brand-name reference product (i.e. that their product has the same active ingredient, labeled strength, dosage form, and route of administration). Generic manufacturers are also protected by a research exemption “safe harbor” from patent infringement lawsuits for the bioequivalence studies they must conduct to gain FDA marketing approval. This provision allows generic manufacturers to begin developing their generic counterparts to brand-name drugs prior to patent expiration without running afoul of patent law, thereby accelerating generic drug market launch.
Oral generic tacrolimus initiation and substitution in the Medicaid population: a new user cohort study
Published in Current Medical Research and Opinion, 2020
Li Chen, Chao Li, Nan Huo, Ahmed Ullah Mishuk, Richard A. Hansen, Ilene Harris, Zippora Kiptanui, Jingjing Qian
The primary outcome measures were initiation of generic oral tacrolimus treatment, and brand-to-generic substitution among brand new users within the 12-month follow-up period. Tacrolimus treatment initiation was defined as first tacrolimus prescription after a 6-month washout period. To identify oral generic and brand tacrolimus prescriptions, National Drug Codes (NDC) for oral tacrolimus were identified from the prescription drug data files and linked with the U.S. FDA’s NDC Directory12. If the patient’s prescription drug was approved through a New Drug Application (NDA), the beneficiary was defined as a new brand user. If the prescription was approved through an abbreviated NDA (ANDA) or an authorized generic (AG), the beneficiary was defined as a new generic user. AG is the same as brand-name drug but is packaged and marketed as generics13.