generic drug
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Introduction
Pharmaceutical agent without Brand-name.
Not protected by trade-mark.
Epidemiology
- increase in adverse events seen (hospitalizations & emergency department visits) after switching from brand name ARB (valsartan, candesartan, losartan) to generic (17%)[15]
Notes
- for a generic to be considered bioequivalent to a Brand-name drug, it must produce similar peak & overall blood levels
- the difference in bioavailability between most bioequivalent products is usually < 4%[4]
- other characteristics need NOT be the same:
- time to reach peak drug concentrations
- formulation
- release rate from the tablet or capsule
- extended-release generics may cause clinician concerns[7]
- generic extended-release metoprolol succinate may have different pharmacokinetics than Toprol-XL[7]
- changes in pill color or shape with subsequent refills may cause patient concers & discontinuation of medication[8]
- American College of Physician's recommends using generics when feasible[9]
- generics may be associated with better medication compliance than brand name drugs[10][11]
- prices for generic drug may vary 40-fold in one city[13]
- when market competition drops, generic drug prices rise[14]
- the cost of generic drugs may be lower when patients purchase medications directly from online suppliers & leave their insurance cards out of the equation[16]
- the Mark Cuban Cost Plus Drug Company launched an online pharmacy in 2022 that sells common generic drugs at cost + 15% + $3 pharmacy fee + $5 shipping fee[17]
More general terms
Additional terms
References
- ↑ Prescriber's Letter 13(1): 2006 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220101&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Prescriber's Letter 13(9): 2006 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220901&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Prescriber's Letter 15(5): 2008 Timed-Release Generic Products: Are they Equivalent to the Brand Product? Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240503&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 4.0 4.1 Prescriber's Letter 15(7): 2008 Generic Drug Variability Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240704&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Prescriber's Letter 16(1): 2009 CHART: Generic Substitution for Commonly Prescribed Drugs Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250108&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Prescriber's Letter 16(10): 2009 Anticipated Availability of First-Time Generics Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=251011&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 7.0 7.1 7.2 Orciari Herman A FDA Planning Study of Generic Metoprolol Over Safety, Efficacy Concerns. NEJM Journal Watch. May 9, 2014 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
- ↑ 8.0 8.1 Kesselheim AS et al Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction: Cohort and Nested Case-Control Studies. Ann Intern Med. 2014;161(2):96-103 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25023248 <Internet> http://annals.org/article.aspx?articleid=1887026
- ↑ 9.0 9.1 Choudhry NK et al Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. Published online 24 November 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26594818 <Internet> http://annals.org/article.aspx?articleid=2471597
- ↑ 10.0 10.1 Gagne JJ, Choudhry NK, Kesselheim AS et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-407 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25222387
- ↑ 11.0 11.1 Gagne JJ, Kesselheim AS, Choudhry NK et al Comparative effectiveness of generic versus brand-name antiepileptic medications. Epilepsy Behav. 2015 Nov;52(Pt A):14-8. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26386779
- ↑ Johansen ME, Richardson C Estimation of Potential Savings Through Therapeutic Substitution. JAMA Intern Med. Published online May 09, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27159226 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2520679
Sharfstein JM, Greene J Promise and Peril for Generic Drugs JAMA Intern Med. Published online May 09, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27159885 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2520673
Ross JS Therapeutic Substitution-Should It Be Systematic or Automatic? JAMA Intern Med. Published online May 09, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27158769 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2520675
Kesselheim AS et al Prevalence and Predictors of Generic Drug Skepticism Among Physicians. Results of a National Survey. JAMA Intern Med. Published online May 09, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27158897 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2520676
Patel MS et al Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. Published online May 09, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27159011 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2520677 - ↑ 13.0 13.1 Hauptman PJ, Goff ZD, Vidic A et al Variability in Retail Pricing of Generic Drugs for Heart Failure. JAMA Intern Med. Published online November 15, 2016. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27846638 <Internet> http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2582937
- ↑ 14.0 14.1 Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High generic drug prices and market competition: A retrospective cohort study. Ann Intern Med 2017 Jul 4; PMID: https://www.ncbi.nlm.nih.gov/pubmed/28672324
- ↑ 15.0 15.1 Leclerc J, Blais C, Rochette L, Hamel D, Guenette L, Poirier P. Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada. A Population-Based Time Series Analysis. Circulation: Cardiovascular Quality and Outcomes. 2017; 10:e003891. Published October 3, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28974512 <Internet> http://circoutcomes.ahajournals.org/content/10/10/e003891
Alter DA When Do We Decide That Generic and Brand-Name Drugs Are Clinically Equivalent? Perfecting Decisions With Imperfect Evidence. Circulation: Cardiovascular Quality and Outcomes. 2017; 10:e004158. Published October 3, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28974513 <Internet> http://circoutcomes.ahajournals.org/content/10/10/e004158 - ↑ 16.0 16.1 NEJM JWatch Editors Medication Prices Often Lower Without Insurance Physician's First Watch, Dec 11, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
Ornstein C, Thomas K Prescription Drugs May Cost More With Insurance Than Without It. New York Times. Dec 9, 2017 https://www.nytimes.com/2017/12/09/health/drug-prices-generics-insurance.html - ↑ 17.0 17.1 Lalani HS, Kesselheim AS, Rome BN. Potential Medicare Part D savings on generic drugs from the Mark Cuban Cost Plus Drug Company. Ann Intern Med 2022 Jun 21 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35724381 https://www.acpjournals.org/doi/10.7326/M22-0756