Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Journal of Pharmacy and Bioallied Sciences

Volumn 3, Issue 1, 2011, Pages 101-108

  Venkatesh, M ^a   Bairavi, V ^a   Sasikumar, K ^a  

^a Orchid Chemicals and Pharmaceuticals Ltd   (India)

Author keywords

Antibiotic; generic drug; Hatch Waxman Act; US regulation

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; ANTIBIOTIC AGENT; BLEOMYCIN; CEPHALOSPORIN DERIVATIVE; COLISTIN; DEXAMETHASONE PLUS TOBRAMYCIN; DORIPENEM; GENERIC DRUG; HELIDAC; KANAMYCIN; MACROLIDE; MEROPENEM; NORFLOXACIN; PENICILLIN G; PIPERACILLIN; QUINOLINE DERIVED ANTIINFECTIVE AGENT; TIGECYCLINE;

ABDOMINAL INFECTION; ANTIBIOTIC RESISTANCE; BACTERIAL EYE INFECTION; BIOEQUIVALENCE; CERTIFICATION; COST EFFECTIVENESS ANALYSIS; COST MINIMIZATION ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DUODENUM ULCER; EXPIRATION DATE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE SYSTEM; HELICOBACTER INFECTION; HISTORY OF MEDICINE; HUMAN; PRIORITY JOURNAL; REVIEW; SKIN INFECTION; UNITED STATES; URINARY TRACT INFECTION;

EID: 79952951305     PISSN: None     EISSN: 09757406     Source Type: Journal    
DOI: 10.4103/0975-7406.76481     Document Type: Review

References (30)

1. Mortality Statistics: Available from: Http://www.nationmaster.com/ graph/mor-bac-inf-of-uns-sit-percap-infection-unspecified-site-percapita. [Last cited on 2010 Mar 31].
2. Lauter CB. Antibiotic therapy of life-threatening infectious diseases in the emergency department. Ann Emerg Med 1989;18:1339-43. (Pubitemid 20014625)
3. Lee CJ. Drug discovery and preclinical research. In Clinical trials of drugs and biopharmaceuticals 1st ed. New York: Taylor and Francis; 2006. p. 1-2.
4. Kiefer DM. The advent of the sulfa drugs in the mid-1930s gave physicians a powerful weapon. Available from: Http://pubs.acs.org/ subscribe/archive/tcaw/ 10/i06/toc /toc-i06.html [last cited in 2010 Jun 15].
5. Garattini L, Tediosi F. A comparative analysis of generics markets in five European countries. Health Policy 2000;51:149-62. (Pubitemid 30138050)
6. Seligman SJ. Reduction in antibiotic costs by restricting use of an oral cephalosporin. Am J Med 1981;71:841-4.
7. National Association of Chain Drug Stores, Industry Facts-at-a- Glance. Available from http://www.nacds.org [Last accessed on 2010 on Mar 8]
8. The Henry J. Kaiser Family Foundation, Prescription Drug Trends. Available from: Www.kff.org/rxdrugs/upload/3057-08.pdf, accessed November 14, 2010.
9. US Food and Drug Administration, Center for Drug Evaluation and Research. Generic Competition and Drug Prices. Available from: Http://www.fda.gov/ AboutFDA/CentersOffices/CDER/ucm129385. htm [Last accessed on 2010 Mar 12].
10. Gleckman RA, Czachor JS. Antibiotic Side Effects. Semin Respir Crit Care Med 2000;21:61-70.
11. Antimicrobial Resistance Interagency Task Force 2002 Annual Report. Available from: Http://www.cdc.gov/drugresistance/ actionplan/2002report/index. htm [Last cited on 2010 Mar 15].
12. Antibiotics and Drug Resistance: BioPharm Reports (VennBio Ltd.), Available from: Http://www.researchandmarkets.com/ reports/579550/. [Last cited on 2008 Feb 26].
13. Drug Price Competition and Patent Term Restoration Act of 1984: Available from: Http://www.fda.gov/newsevents/testimony/ ucm115033.htm. [Last cited on 2010 Mar 15].
14. Piasno DJ. Overview of Drug Development and the FDA. In FDA Regulatory Affairs-A guide for prescription drugs, medical devices, and biologics 2nd ed. New York: CRC Press; 2004. p. 1-20.
15. Harrision DJ. Antibiotic application requirements. Clin Res Practices Drug Reg Affairs 1986;4:265-7.
16. Irving L Weisen. FDA's antibiotic regulatory scheme: Then and Now. In: Berry, IR, Martin RP, editors. The Pharmaceutical Regulatory Process. 2nd ed. New York: Informa Healthcare; 2008. p. 133.
17. Ferrara I, Kong Y. Can health insurance coverage explain the generic competition paradox? Econ Lett 2008;101:48-52.
18. Cars O, Mölstad S, Melander A. Variation in antibiotic use in the European Union. Lancet 2001;357:1851-3. (Pubitemid 32539121)
19. Ferech M, Coenen S, Malhotra-Kumar S, Dvorakova K, Hendrickx E, Suetens C, et al. European Surveillance of Antimicrobial Consumption (ESAC): Outpatient antibiotic use in Europe. J Antimicrob Chemother 2006;58:401-7. (Pubitemid 44294954)
20. Nation R, Sanso LN. Bioequivalence requirements for generic products. Pharmac Ther 1994;62:41-55. (Pubitemid 24234857)
21. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003;25:2875-90. (Pubitemid 37510596)
22. Bioequivalence-should we trust antibiotics? South Afr J Epidemiol Infect 2005;20:78-9.
23. Bansal P, Sharma A. Generic Drugs and Their Approval-Part I. Magazine of Intellectual property and technology. 2005.
24. Pharma industry interest in antibiotics. Available from: Http://haicontroversies.blogspot.com/2010/11/needed-some-newantibiotics. html [Last accessed on 2010 Oct 01].
25. Conly JM, Johnston BL. Where are all the new antibiotics? The new antibiotic paradox. Can J Infect Dis Med Microbiol 2005;16:159-60. (Pubitemid 41113429)
26. Hancock RE. Mechanisms of action of newer antibiotics for Grampositive Pathogens. Lancet Infect Dis 2005;5:209-18. (Pubitemid 40410066)
27. Facts About the Antibiotic RandD Pipeline: Why Antibiotics Require Special Treatment, Available from: Http://www.idsociety.org/Content. aspx?id=5652 [Last cited on 2010 Mar 15].
28. Guillemot D. Antibiotic use in humans and bacterial resistance. Curr Opin Microbiol 1999;2:494-8. (Pubitemid 29477175)
29. Available from: Http://www.fda.gov/Safety [Last cited on 2010 Nov 12].
30. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Available from: Http://www.accessdata.fda.gov/scripts/ cder/ob/docs/querytn.cfm [last cited on 2010 Nov 12].