EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS
Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming process most companies loss their patent exclusivity before drug gets marketing approvals. To prevent innovators from monetary losses occurred in drug development and to encourage innovation US FDA and EMEA introduced exclusivities under various categories. Within the period of drug exclusivity no application is accepted either ANDA or 505 (b) (2).
2. Lapointe S, Ph.D. Partner, Patent Agent, Comparison of the Non-patent Drug Exclusivities Available in the United States, Canada, Europe and Japan [Internet].The International Economic Forum of the Americas; 2012 June [Cited June 01]. Available from:
3. Department of Health and Human Services. The Orphan drug act Implementation and impact. [Internet]. Department of Health and Human Services, Office of Inspector general; 2001 May [Cited June 01]. Available from:
4. U.S. Food and Drug Administration. The Pediatric Exclusivity Provision [Internet]. Department of Health and Human Services, U.S. Food and Drug Administration; 2001 Jan [Cited June 01]. Available from:
5. Clift C. Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals [Internet]. [London, U.K.]: Data; 2010 [Cited 2014 June 01]. Available from:
6. Horton L R, Jacqueline M, Jaime T, Innovator Rights under the New European Union Medicines Legislation [Internet]. 2004 June [Cited June 01]. Available from:
7. Hoppu K. Poison Information Centre, Helsinki University Central Hospital, Hospital for Children and Adolescents and Dept. Of Clinical Pharmacology. A Summary of the EU Pediatric Initiatives [Internet]. [Finland]. University of Helsinki: Helsinki; 2007 July [Cited June 01]. Available from:
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM