Advanced search
Publication Cover
Journal of Market Access & Health Policy Volume 2, 2014 - Issue 1
Journal homepage
3,089
Views
21
CrossRef citations to date
0
Altmetric
Original Research Articles

Drug reformulations and repositioning in the pharmaceutical industry and their impact on market access: regulatory implications

Susana MurteiraUniversity of Lyon University Claude Bernard Lyon I, UFR d'Odontologie, 11 rue Guillaume Paradin, 69372, Lyon, Cedex 08, France;Lundbeck SAS, 37-45, Quai du Président Roosevelt, 92445 Issy-les-Moulineaux, Cedex, Paris, FranceCorrespondence[email protected]
,
Aurélie MillierCreativ-Ceutical S.A., 215, rue du Faubourg St-Honoré 75008, Paris, France
,
Zied GhezaielCreativ-Ceutical S.A., 215, rue du Faubourg St-Honoré 75008, Paris, France
&
Michel LamureUniversity of Lyon University Claude Bernard Lyon I, UFR d'Odontologie, 11 rue Guillaume Paradin, 69372, Lyon, Cedex 08, France
Article: 22813 | Received 09 Nov 2013, Accepted 16 Dec 2013, Published online: 29 Jan 2014

References

  • Murteira S , Ghezaiel Z , Karray S , Lamure M . Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature. J Market Access Health Policy. 2013; 1: 1.
  • Sleigh SH , Barton CL . Repurposing strategies for therapeutics. Pharm Med. 2010; 24(3): 151–9.
  • Datamonitor reports. Lifecycle management strategies: reformulation: success hinges on delivering significant improvement in disease outcome. 2012; USA (NY): Datamonitor. 30 p. Report No.: HC00246-001..
  • Agranat I, Caner H, Caldwell J. Putting chirality to work: the strategy of chiral switches. Nat Rev Drug Discov. 2002; 1(10): 753–68. [PubMed Abstract].
  • Murteira S , Millier A , Toumi M . Drug repositioning and reformulation in pharmaceutical industry and its impact on market access: market access implications. In press; J Market Access Health Policy.
  • Sukhai MA, Spagnuolo PA, Weir S, Kasper J, Patton L, Schimmer AD. New sources of drugs for hematologic malignancies. Blood. 2011; 117(25): 6747–55. [PubMed Abstract].
  • Food and Drug Administration. Glossary of terms [Internet]. Drugs@FDA. [updated 2012 Aug 16; cited 2013 May 12]. Available from: http://www.fda.gov/drugs/informationondrugs/ucm079436.htm.
  • Oprea TI, Bauman JE, Bologa CG, Buranda T, Chigaev A, Edwards BS. Drug repurposing from an academic perspective. Drug Discov Today Ther Strateg. 2011; 8(3–4): 61–9. [PubMed Abstract] [PubMed CentralFull Text].
  • Datamonitor reports. Drug repositioning strategies: serendipity by design. 2008; USA (NY): Datamonitor. 97. Report No.: DMHC2400.
  • Food and Drug Administration. FDA guidance for industry: applications covered by section 505(b)(2). FDA. [Online] Apr 10, 1999. [cited 2013 May 11]. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf.
  • Phelps K . Repositioning drugs to enhance a product's lifecycle. Drug Discov Today Ther Strateg. 2011; 8(3–4): 97–101.
  • Witkowski TX . Intellectual property and other legal aspects of drug repurposing. Drug Discov Today Ther Strateg. 2011; 8(3–4): 139–43.
  • Ashburn TT, Thor KB. Drug repositioning: identifying and developing new uses for existing drugs. Nat Rev Drug Discov. 2004; 3(8): 673–83. [PubMed Abstract].
  • Mugglestone CJ, Mariz S, Lane ME. The development and registration of topical pharmaceuticals. Int J Pharm. 2012; 435(1): 22–6. [PubMed Abstract].
  • Papakrivos J . Regulatory strategy for the development of known drugs in new therapeutic areas. 2011; Bonn, Germany: Bonn University.
  • Smith RB . Repositioned drugs: integrating intellectual property and regulatory strategies. Drug Discov Today Ther Strateg. 2011; 8(3–4): 131–37.
  • Hermann AMM . Drug repositioning: extracting added value from prior R&D investments. 2010; Massachusetts: Cambridge Healthtech Institute.
  • Padhy BM, Gupta YK. Drug repositioning: re-investigating existing drugs for new therapeutic indications. J Postgrad Med. 2011; 57(2): 153–60. [PubMed Abstract].
  • Ashwell MA , Eathiraj S , Filikov A , Koerner S , Lapierre JM , Liu Y et al. . Substituted benzo[f]lmidazo[1,2-d]pyrido[2,3-b][1,4]diazepine compounds, 8,569,331 (Patent). 2012. United States Patent and Trademark Office Database.
  • Dunn PJ , Wood AS . Process for preparing sildenafil. 6,066,735 (Patent). 2000. United States Patent and Trademark Office Database.
  • Dipierro G , Giannos SA . Biosynchronous transdermal drug delivery for longevity, anti-aging, fatigue management, obesity, weight loss, weight management, delivery of nutraceuticals, and the treatment of hyperglycemia, alzheimer's disease, sleep disorders, parkinson's disease, aid. 8,252,321 (Patent). 2012. United States Patent and Trademark Office Database.
  • Holt RIG , Barnett AH , Bailey CJ . Bromocriptine: old drug, new formulation and new indication. Diabetes Obes Met. 2010; 12(12): 1048–57.
  • Allarakhia M. Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying 840 the lessons across diseases. Drug Des Devel Ther. 2013; 7: 753–66. [PubMed Abstract] [PubMed CentralFull Text].

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.