Generic Substitution for Psychotropic Drugs

CNS Spectrums ◽  
2009 ◽  
Vol 14 (9) ◽  
pp. 1-7 ◽  
Author(s):  
Pierre Blier
Keyword(s):  
Generic Drug ◽  
Psychotropic Drugs ◽  
Generic Substitution ◽  
Generic Drugs ◽  
Drug Application ◽  
The United States ◽  
Third Party ◽  
Brand Name ◽  
Branded Drug ◽  
United States Food

Most antidepressants and other psychotropics in clinical use are available as generic formulations (Table). The availability of lower-priced, generic drugs can benefit patients and third-party payers, but it should not be assumed that all generic drugs are equally beneficial. There are numerous reports in the literature of unexpected and untoward consequences that occur when a generic drug is substituted for the original brand-name drug. A previously stable clinical response may suddenly deteriorate, or the patient may experience new or more severe adverse events (AEs). The United States Food and Drug Administration requires that manufacturers of generic drugs demonstrate that their formulation has pharmacokinetic properties similar (or bioequivalent) to the brand-name drug. Bioequivalency studies are conducted in healthy volunteers, not in patients who would be treated with that drug. Moreover, bioequivalency studies are conducted on a current lot of the branded drug and do not account for variability between lots of the generic formulation. The manufacturer is only required to submit bioequivalency data that support the Abbreviated New Drug Application (ANDA); the FDA does not require disclosure of failed bioequivalence studies. Unlike brand-name drugs, lengthy and costly clinical studies are not required to show that the generic drug is effective and safe.Although the FDA has taken the position that bioequivalence and therapeutic equivalence are equal, many questions related to the use of generic drugs remain unanswered. The following question-and-answer session is an excerpt of an interview with Pierre Blier, MD, PhD, conducted by Diane Sloan, PharmD, which addresses the issue of generic substitution of psychotropic drugs.

Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

2021 ◽  
pp. 331-335
Author(s):  
Hindustan Abdul Ahad ◽  
Haranath Chinthaginjala ◽  
Gangireddy Jayasimha Reddy ◽  
Pasupuleti Dheeraj Krishna ◽  
Syed Rahamathulla ◽  
...  
Keyword(s):  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Brand Name ◽  
Application Process ◽  
Drug Products ◽  
Federal Food ◽  
United States Food ◽  
States Food ◽  
New Drug Application

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

scholarly journals ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)

2018 ◽  
Vol 3 (1) ◽  
pp. 41-61
Author(s):  
Lakshmi Kanth Maddela ◽  
Insukh Oh
Keyword(s):  
United States ◽  
Drug User ◽  
Drug Administration ◽  
Generic Drug ◽  
Generic Drugs ◽  
Food And Drug Administration ◽  
Drug Application ◽  
United States Food ◽  
States Food ◽  
User Fee

A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has its own regulatory strategy to approve and allow generic drugs in to the market, which is named as Generic Drug Submission Review. FDA would like to slash the review time of generic drug application without compromising the quality and efficacy of proposed generic drugs for the intended use and to make them available to consumers in short time as possible. FDA has introduced Generic Drug User Fee program to supplement appropriate funding for resource management to ensure that consumers continue to receive the significant benefits offered by generic drugs. The purpose of this article is to present a concise overview about Generic Drug User Fee program and the recent advances in Abbreviated New Drug Application (ANDA) review process.

The generic drug market in Japan: will it finally take off?

2010 ◽  
Vol 6 (3) ◽  
pp. 369-389 ◽  
Author(s):  
Toshiaki Iizuka ◽  
Kensuke Kubo
Keyword(s):  
Health Care ◽  
Generic Drug ◽  
Generic Substitution ◽  
Drug Market ◽  
Government Policies ◽  
Brand Name ◽  
Market Exclusivity ◽  
Market Participants ◽  
The Government ◽  
Generic Usage

AbstractHistorically, brand-name pharmaceuticals have enjoyed long periods of market exclusivity in Japan, given the limited use of generics after patent expiration. To improve the efficiency of the health-care system, however, the government has recently implemented various policies aimed at increasing generic substitution. Although this has created expectations that the Japanese generic drug market may finally take off, to date, generic usage has increased only modestly. After reviewing the incentives of key market participants to choose generics, we argue that previous government policies did not provide proper incentives for pharmacies to boost generic substitution. We offer some recommendations that may help to increase generic usage.

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

Present Status of Supplemental Application Submission in USFDA

2018 ◽  
Vol 9 (3) ◽  
Author(s):  
Verma S ◽  
Misri P ◽  
Yashwant . ◽  
Haque A
Keyword(s):  
United States ◽  
Drug Administration ◽  
Present Status ◽  
Drug Product ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
United States Food ◽  
States Food ◽  
Year 2000

Objective: In order to reach to the market, a drug product has to undergo various phases of scrutiny assuring its quality, safety and efficacy. Once the experimental drug promises its safety, efficacy and quality it is permitted to be marketed by the regulator. The drug is still present under surveillance for possibility of any adverse drug reaction or any other alteration or a new indication. If any modification is to be done, then the applicant/sponsor needs to file a supplemental application. This article provides information about present status of supplemental new drug application submitted and approved to the United States food and drug administration. Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000 to 2016. The data has been segregated and statistically analyzed using ANOVA on the basis of different categories of approved applications. Results: As per the analysis, from the year 2000 to 2016, a total of 69,585 applications was filed to USFDA, amongst which 9499 were original applications and 60,086 were supplemental applications.

The Role of Risk Aversion in Reverse Payment Agreements

2018 ◽  
Vol 63 (2) ◽  
pp. 237-245
Author(s):  
Wenqing Li
Keyword(s):  
Risk Aversion ◽  
Generic Drug ◽  
Drug Company ◽  
Drug Manufacturer ◽  
Patent Litigation ◽  
Brand Name ◽  
Branded Drug ◽  
Generic Company ◽  
Settlement Agreement

Both the courts and the economists have identified risk aversion as a justification for reverse payment agreements, especially the risk aversion of brand-name companies. However, existing economic researches show whether risk aversion can be a rationale for reverse payment agreements depends on the type of reverse payment agreements reached. In “complete” settlement agreement where a brand-name drug manufacturer provides consideration to a generic drug company to completely settle the patent litigation, with agreed-upon entry dates for the generic, risk aversion does not provide a justification for reverse payment, but asymmetry in risk aversion can be a rationale for reverse payment. In “partial” settlement agreement where a branded drug manufacturer provides consideration to a generic drug company in exchange for the generic to agree not to enter the market while they continue the patent litigation, it is not the risk aversion of the brand company, but the risk aversion of the generic company that can facilitate the parties to reach a partial settlement agreement with reverse payment that serves the procompetitive purpose.

The Ability of Anaesthetists to Identify Generic Medications from Trade Names

2009 ◽  
Vol 37 (4) ◽  
pp. 624-629 ◽  
Author(s):  
D. E. P. Bramley
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
Clinical Problem ◽  
Brand Names ◽  
Prescription Medications ◽  
Brand Name ◽  
Drug Substances ◽  
Generic Medications ◽  
Trade Names ◽  
Theoretical Test

The recent proliferation of brand names for prescription medications has made the clinician's task of identifying the corresponding generic drug substances more difficult. A survey of 86 anaesthetists and anaesthetic trainees at two Melbourne hospitals was conducted to measure the extent to which this was perceived to be a clinical problem. In addition, a theoretical test was administered to examine the ability of these anaesthetists to correctly identify generic drugs and therapeutic groups when only the brand name is provided. The results indicated this is perceived to be a genuine clinical problem, with more than 80% of respondents encountering unfamiliar trade names ‘often’ or ‘always’ and the test revealing that fewer than one third of commonly prescribed brand names were identified correctly.

Assessment of Generic Drug Discount Programs Offered by Large Chain Pharmacies in the United States

2009 ◽  
Vol 6 (4) ◽  
pp. 363-368 ◽  
Author(s):  
Nilanjana Dwibedi ◽  
Sujit S. Sansgiry
Keyword(s):  
United States ◽  
Health Care ◽  
Health Care Costs ◽  
Generic Drug ◽  
Generic Drugs ◽  
The United States ◽  
Drug Classes ◽  
Similarities And Differences ◽  
Care Costs

The purpose of this study was to evaluate and compare various Generic Drug Discount Programs (GDDPs) offered by large chain pharmacies in the United States to understand similarities and differences within them. Data collected included questions such as whether the pharmacy offered any GDDP, discounted amount, total number of generic drugs and drug classes included in the GDDP, and whether the discounted amount was differentiated by the term ‘insured’ or ‘uninsured’. Comparison of GDDPs was conducted by matching drugs covered under each GDDP with top-100 generics consumed in the United States in 2007. Of the 37 pharmacies evaluated, 22 offered GDDPs. GDDP offered by Pathmark pharmacy contributed the highest number of top-100 drugs both in dollar amounts and in number of units sold. In conclusion, more than half of the large chain pharmacies in the United States offered some form of GDDPs, which were different across pharmacies. These GDDPs offered consumers an option to reduce their health-care costs. Most programs varied by number of drugs covered, days' supply, enrollment requirements and the discounted amounts for generic drugs.

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

2021 ◽  
pp. 174113432110007
Author(s):  
Lovely Joylein ◽  
Bishop Adhikari ◽  
Megha Chellath Kottayi ◽  
GS Ravi ◽  
Akhilesh Dubey
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
The United States ◽  
Economic Benefits ◽  
Dosage Forms ◽  
Regulatory Requirements ◽  
Solid Dosage Forms ◽  
Drug Products ◽  
Solid Dosage ◽  
Pharmaceutical Manufacturers

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.

scholarly journals Prescription and use of “equivalent” drugs

2007 ◽  
Vol 1 (2) ◽  
pp. 69-87
Author(s):  
Mario Eandi
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Generic Drug ◽  
Generic Drugs ◽  
Case Reports ◽  
Branded Drug ◽  
Italian Context

Three case reports, where an “equivalent” drugs is prescribed, are described: a patient treated with lanzoprazole, a man with acute myocardial infarction and a young man with epilepsy. These reports are emblematic of the doubts and problems that doctors have to afford in the choice of a generic drug instead of a branded drug. The Author examines not only clinical, legislative and economical aspects of prescription of generic drugs in the Italian context, but also common questions that patients may ask when a generic drug is prescribed.

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