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The alteration of some aspect of a blockbuster drug’s formulation—e.g., purification, altered route of delivery—or the seeking of approval to market the agent for another clinical indication as a means of extending the drug’s (lucrative) patent protection
References in periodicals archive ?
Wolfgang Beier, Medical Director and Co-Founder, explains: "With our unique network of interdisciplinary drug-development capabilities and our leading nanotechnology platform, we are a reformulation expert for high barrier generics for proactive product life-cycle-management or line-extensions as well as the development of novel nano- and micronized drugs.
Ed Komorowski, technical director at Dairy UK, said the FSNs preference for reformulation was at odds with its traffic light labelling.
The work comes as the FSA switches its attention to cutting consumption of saturated fat and sugar among the public, and follows reformulation work related to salt reduction.
The paint industry is seeking use of EGBE as an alternative low-ozone-forming solvent in the reformulation of coatings in compliance with maximum achievable control technology (MACT) standards for various National Emission Standard for HAPs, as well as the NESHAP for Miscellaneous Coating Manufacturing (MCM).
The Food and Drug Administration (FDA) approves more reformulations than new chemical entities each year.
Mason added that it had not been decided whether there would be any advertising around the reformulations.
This report assesses the various approaches to reformulation in the protection of revenues for pharmaceuticals that are in the midpoint of their lifecycles.
Chief Executive Officer of Somanta, commented, "This expanded agreement provides us the opportunity to participate in the largest market in the world for oncology drugs, and if our efforts with respect to a reformulation are successful, we will enjoy a share of the economics on a global basis for these formulations.
Slow generic uptake, reformulations, follow-on products and new market entrants will ensure steady long-term growth of the epilepsy market despite several high profile patent expiries.
This title is an overview of product reformulation, new formulations and combination products; and how, when, and why manufacturers implement reformulation strategies It is a review of reformulations in cardiovascular, CNS, diabetes, and womens health It makes a comparison of successful and less effective reformulation strategies recently implemented, and evaluation of future reformulation strategies.
com/reports/c41448) has announced the addition of the new Datamonitor report "Pipeline Insight: Parkinsons Disease And Restless Legs Syndrome - Reformulations Set To Drive Near-Term Growth" to their offering.