Summary: Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.
- Berg M, Gross R, Tomaszewski K, Zingaro W, Haskins L. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology. 2008;71:525-30 pubmed publisher..Physicians, pharmacists, patients, and policy makers should be aware that for some patients there may be risks associated with switching from brand to generic AEDs. ..
- Jones R, Fritsche T, Moet G. In vitro potency evaluations of various piperacillin/tazobactam generic products compared with the contemporary branded (Zosyn, Wyeth) formulation. Diagn Microbiol Infect Dis. 2008;61:76-9 pubmed publisher..The average -16% activity across all generic lots was equivalent to underdosing piperacillin/tazobactam by 2.6 g daily for serious clinical infections (4.5 g Q6 h). ..
- Chakraborty H, Devi P, Sarkar M, Dasgupta D. Multiple functions of generic drugs: future perspectives of aureolic acid group of anti-cancer antibiotics and non-steroidal anti-inflammatory drugs. Mini Rev Med Chem. 2008;8:331-49 pubmedNon-steroidal anti-inflammatory drugs and aureolic acid group of anti-cancer drugs belong to the class of generic drugs. Research with some members of these two groups of drugs in different laboratories has unveiled functions other than ..
- LeLorier J, Duh M, Paradis P, Lefebvre P, Weiner J, Manjunath R, et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology. 2008;70:2179-86 pubmed publisher..Switch to generic lamotrigine was significantly associated with increased physician visits and hospitalizations. ..
- Dansereau R, Crail D, Perkins A. In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US. Curr Med Res Opin. 2009;25:449-52 pubmed..Copies of generic alendronate sodium tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not considered adequate to establish similar disintegration characteristics. ..
- Rodriguez C, Agudelo M, Cataño J, Zuluaga A, Vesga O. Potential therapeutic failure of generic vancomycin in a liver transplant patient with MRSA peritonitis and bacteremia. J Infect. 2009;59:277-80 pubmed publisher..It raises concern about therapeutic equivalence of generic vancomycin. ..
- Mastoraki E, Michalopoulos A, Kriaras I, Mouchtouri E, Falagas M, Falagas M, et al. Incidence of postoperative infections in patients undergoing coronary artery bypass grafting surgery receiving antimicrobial prophylaxis with original and generic cefuroxime. J Infect. 2008;56:35-9 pubmed..The findings of our study provide additional evidence regarding the problem of substandard drugs, in our case a formulation of a generic antibiotic, even in developed countries. ..
- Papsdorf T, Ablah E, Ram S, Sadler T, Liow K. Patient perception of generic antiepileptic drugs in the Midwestern United States. Epilepsy Behav. 2009;14:150-3 pubmed publisher..A significant percentage of patients also reported switching back to a brand-name AED and expressed concern over pharmacies switching to generic AEDs without a patient's or physician's consent. ..
- Sheehy O, Kindundu C, Barbeau M, LeLorier J. Differences in persistence among different weekly oral bisphosphonate medications. Osteoporos Int. 2009;20:1369-76 pubmed publisher..Persistence to weekly oral preparations remains suboptimal, particularly in patients who receive generic alendronate. Alternative solutions are needed to improve the real life effectiveness of osteoporosis therapies...
- Berg M, Gross R, Haskins L, Zingaro W, Tomaszewski K. Generic substitution in the treatment of epilepsy: patient and physician perceptions. Epilepsy Behav. 2008;13:693-9 pubmed publisher..Additional investigation on bioequivalence may help address ongoing concerns and inform policy-making decisions. ..
- Frank R. The ongoing regulation of generic drugs. N Engl J Med. 2007;357:1993-6 pubmed
- Miranda E, Pinto C, dos Reis A, Emmerick I, Campos M, Luiza V, et al. [Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil]. Cad Saude Publica. 2009;25:2147-58 pubmed..It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.
- Heaney D, Sander J. Antiepileptic drugs: generic versus branded treatments. Lancet Neurol. 2007;6:465-8 pubmed..mean that substantial drug-budget savings may be possible by switching from innovator brands to cheaper generic drugs. Such savings have been achieved in many other treatment areas...
- Haskins L, Tomaszewski K, Crawford P. Patient and physician reactions to generic antiepileptic substitution in the treatment of epilepsy. Epilepsy Behav. 2005;7:98-105 pubmed..Further evidence is required to understand how costs and effects of generic AED substitution affect patient welfare. ..
- Kirking D, Ascione F, Gaither C, Welage L. Economics and structure of the generic pharmaceutical industry. J Am Pharm Assoc (Wash). 2001;41:578-84 pubmed..Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs...
- Reiffel J. Issues in the use of generic antiarrhythmic drugs. Curr Opin Cardiol. 2001;16:23-9 pubmed..Additionally, guidelines for allowance or avoidance of antiarrhythmic drug formulation substitution are suggested. ..
- Shakweh M, Bravo Osuna I, Ponchel G. Comparative in vitro study of oesophageal adhesiveness of different commercial formulations containing alendronate. Eur J Pharm Sci. 2007;31:262-70 pubmed..The demonstrated differences in adhesiveness suggest that differences in oesophageal tolerance between Fosamax tablets and generics of sodium alendronate may exist. ..
- Kersnik J, Peklar J. Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies. J Clin Pharm Ther. 2006;31:577-83 pubmed..GPs were asked 21 questions regarding their knowledge on generic drugs, awareness of prescribing costs, prices of generic drugs relative to brand name drugs and their attitude ..
- Kluznik J, Walbek N, Farnsworth M, Melstrom K. Clinical effects of a randomized switch of patients from clozaril to generic clozapine. J Clin Psychiatry. 2001;62 Suppl 5:14-7; discussion 23-4 pubmed..Until more studies have been performed, clinicians and administrators should carefully monitor stable Clozaril-treated patients who are being switched to generic clozapine. ..
- Ess S, Schneeweiss S, Szucs T. European healthcare policies for controlling drug expenditure. Pharmacoeconomics. 2003;21:89-103 pubmed..To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for ..
- Swanepoel E, Liebenberg W, de Villiers M. Quality evaluation of generic drugs by dissolution test: changing the USP dissolution medium to distinguish between active and non-active mebendazole polymorphs. Eur J Pharm Biopharm. 2003;55:345-9 pubmed
- Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther. 2003;25:2875-90 pubmedSubstitution of generic drugs for brand-name products is highly controversial and often is met with suspicion by health care providers and patients...
- Chen M, Shah V, Patnaik R, Adams W, Hussain A, Conner D, et al. Bioavailability and bioequivalence: an FDA regulatory overview. Pharm Res. 2001;18:1645-50 pubmed
- Liow K, Barkley G, Pollard J, Harden C, Bazil C. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology. 2007;68:1249-50 pubmed
- Berberich F. Cephalosporin trade names. Pediatr Infect Dis J. 2003;22:388-9 pubmed
- Bialer M. Generic products of antiepileptic drugs (AEDs): is it an issue?. Epilepsia. 2007;48:1825-32 pubmed
- Fischer M, Avorn J. Potential savings from increased use of generic drugs in the elderly: what the experience of Medicaid and other insurance programs means for a Medicare drug benefit. Pharmacoepidemiol Drug Saf. 2004;13:207-14 pubmed..These findings offer some insight into the potential expense of a Medicare prescription drug benefit. ..
- Joyce G, Escarce J, Solomon M, Goldman D. Employer drug benefit plans and spending on prescription drugs. JAMA. 2002;288:1733-9 pubmed..The reduction in drug spending largely benefited health insurance plans because the percentage of drug expenses beneficiaries paid out-of-pocket rose significantly. ..
- Kapczynski A, Crone E, Merson M. Global health and university patents. Science. 2003;301:1629 pubmed
- Duh M, Andermann F, Paradis P, Weiner J, Manjunath R, Cremieux P. The economic consequences of generic substitution for antiepileptic drugs in a public payer setting: the case of lamotrigine. Dis Manag. 2007;10:216-25 pubmed..Payers may weigh smaller-than-expected cost reductions against a possible decrease in effectiveness to assess the relevance of mandatory generic switching of lamotrigine. ..
- Scott Morton F. The strategic response by pharmaceutical firms to the Medicaid most-favored-customer rules. Rand J Econ. 1997;28:269-90 pubmed..Hospital prices show little change. The results suggest that the MFC rule caused higher prices for some pharmaceutical customers. ..
- Van Wijk B, Klungel O, Heerdink E, de Boer A. Generic substitution of antihypertensive drugs: does it affect adherence?. Ann Pharmacother. 2006;40:15-20 pubmed..When a less-expensive antihypertensive generic equivalent becomes available, generic substitution should be considered to achieve economic benefits. ..
- Allenet B, Barry H. Opinion and behaviour of pharmacists towards the substitution of branded drugs by generic drugs: survey of 1,000 French community pharmacists. Pharm World Sci. 2003;25:197-202 pubmedIn 1999, a new law was introduced, giving French pharmacists the right to switch from branded to generic drugs, unless the prescriber had specified that substitution was not permitted...
- Halkin H, Dushenat M, Silverman B, Shalev V, Loebstein R, Lomnicky Y, et al. Brand versus generic alendronate: gastrointestinal effects measured by resource utilization. Ann Pharmacother. 2007;41:29-34 pubmed..We found insufficient evidence to indicate major differences in UGIT adverse effects related to use of daily generic, as compared with brand, alendronates. ..
- Crawford P, Feely M, Guberman A, Kramer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure. 2006;15:165-76 pubmed
- Himmel W, Simmenroth Nayda A, Niebling W, Ledig T, Jansen R, Kochen M, et al. What do primary care patients think about generic drugs?. Int J Clin Pharmacol Ther. 2005;43:472-9 pubmedTo examine the attitude of patients towards generic drugs and prescriptions containing generic drugs as an alternative to brand-name products, with a special focus on information on patients attitude to generic drugs provided by their ..
- Epstein S, Cryer B, Ragi S, Zanchetta J, Walliser J, Chow J, et al. Disintegration/dissolution profiles of copies of Fosamax (alendronate). Curr Med Res Opin. 2003;19:781-9 pubmed..Additional testing is warranted to evaluate the pharmacokinetics and clinical safety of these copies. ..
- Mott D, Cline R. Exploring generic drug use behavior: the role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution. Med Care. 2002;40:662-74 pubmed..Additional efforts to increase generic drug use likely should be targeted at prescribers. ..
- Borgheini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther. 2003;25:1578-92 pubmed..The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects. ..
- Nuss P, Taylor D, De Hert M, Hummer M. The generic alternative in schizophrenia: opportunity or threat?. CNS Drugs. 2004;18:769-75 pubmed..The availability of generic drugs is widely regarded as an opportunity to reduce expenditure on drug costs and deploy limited resources more ..
- Ashworth M, Golding S, Majeed A. Prescribing indicators and their use by primary care groups to influence prescribing. J Clin Pharm Ther. 2002;27:197-204 pubmed..Further work is needed on which indicators are most likely to act as catalysts to prescribing change. ..
- Andersson K, Sonesson C, Petzold M, Carlsten A, Lonnroth K. What are the obstacles to generic substitution? An assessment of the behaviour of prescribers, patients and pharmacies during the first year of generic substitution in Sweden. Pharmacoepidemiol Drug Saf. 2005;14:341-8 pubmed..Generic substitution has been implemented in practice although it did not reach full dividend during the first year. The potential savings from extended use of generic substitution are substantial. ..
- Hellström J, Rudholm N. Side effects of generic competition?. Eur J Health Econ. 2004;5:203-8 pubmed..Generic substitution laws and measures to increase generic competition may thus have unintended consequences since these results show a positive relationship between generic market shares and reported side effects. ..
- Christensen T, Kirking D, Ascione F, Welage L, Gaither C. Drug product selection: legal issues. J Am Pharm Assoc (Wash). 2001;41:868-74 pubmed..Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase. ..
- Oyugi J, Byakika Tusiime J, Charlebois E, Kityo C, Mugerwa R, Mugyenyi P, et al. Multiple validated measures of adherence indicate high levels of adherence to generic HIV antiretroviral therapy in a resource-limited setting. J Acquir Immune Defic Syndr. 2004;36:1100-2 pubmed..The relative ease of administration of the 30-day visual analog scale suggests that this may be the preferred method to assess adherence in resource-poor settings. ..
- Lofgren H. Generic drugs: international trends and policy developments in Australia. Aust Health Rev. 2004;27:39-48 pubmedPublic and private third-party payers in many countries encourage or mandate the use of generic drugs. This article examines the development of generics policy in Australia, against the background of a description of international trends ..
- Kramer G, Steinhoff B, Feucht M, Pfäfflin M, May T. Experience with generic drugs in epilepsy patients: an electronic survey of members of the German, Austrian and Swiss branches of the ILAE. Epilepsia. 2007;48:609-11 pubmed
- Wilner A. Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav. 2004;5:995-8 pubmed..Fifty-two (18.4%) neurologists agreed that the Food and Drug Administration standards for AED bioavailability are sufficiently narrow; 231 (81.6%) did not. ..
- Wasserfallen J, Shimia S, Biollaz J, Pannatier A. [Generic drug prescribing: pilot study on the impact of the new drug pricing system on costs and potential savings]. Rev Med Suisse. 2006;2:865-6, 868-71 pubmed..In this specific setting, savings linked with forced generic drug prescription was weak (4 to 5%), and the expected savings of the new drug pricing system were not observed. ..
- Bertoldi A, Barros A, Hallal P. Generic drugs in Brazil: known by many, used by few. Cad Saude Publica. 2005;21:1808-15 pubmedThis study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city...
- McManus P, Birkett D, Dudley J, Stevens A. Impact of the Minimum Pricing Policy and introduction of brand (generic) substitution into the Pharmaceutical Benefits Scheme in Australia. Pharmacoepidemiol Drug Saf. 2001;10:295-300 pubmed..Case studies showed a larger premium resulted in a greater shift of patients from drugs with a brand premium to the benchmark alternative. ..
- Gill P, Roalfe A. Determinants of prescribing costs amongst single-handed general practitioners. J Clin Pharm Ther. 2001;26:433-5 pubmed..5% of the variation in costs/ASTRO-PU. This study highlights that very little of the variation in prescribing costs can readily be explained. Further research is needed to document contributing factors. ..
- Shah V. Progress in methodologies for evaluating bioequivalence of topical formulations. Am J Clin Dermatol. 2001;2:275-80 pubmed..However, confidence in this methodology needs to be established, particularly regarding its relevance to clinical drug efficacy. ..