Orphan drug

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orphan drug

[ôr′fən]
Etymology: Gk, orphanos, without parents; ME, drogge
a term that generally refers to drugs needed to treat rare diseases but can encompass any pharmaceutic product available to physicians and patients in countries other than the United States that has not been "adopted" by a domestic pharmaceutic manufacturer or distributor. An orphan drug may not be available in the United States because total sales would not justify the expense of research and development or because the medication may be a natural substance that cannot be effectively protected by patent laws against competition from a similar form of the product. The U.S. Orphan Drug Act of 1983 offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the United States for rare diseases affecting fewer than 200,000 people. The FDA assists in the process with its office of Orphan Product Development.
Any drug, biological, medical device, or food of potential or actual use in treating ‘orphan’ diseases—diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products

orphan drug/product

Any drug, biological, medical device, or food of potential or actual use in treating 'orphan' diseases–diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products. See Orphan disease. Cf Pseudoorphan drug.

Orphan drug

A term for a drug that treats a rare disease, defined by the Food and Drug Administration (FDA) as one that affects fewer than 200,000 Americans. The FDA has an Office of Orphan Products Development (OOPD), which offers grants to researchers to develop these products.
References in periodicals archive ?
Seven-year marketing exclusivity to sponsors of approved orphan products.
The potential end-users of an orphan product may not be aware of therapeutic or preventive options.
Since its creation in 1983, the Orphan Products Grants Program has provided more than $350 million to fund more than 570 new clinical studies and supported the marketing approval of more than 50 products.
20, 2015 /PRNewswire/ -- The National Organization for Rare Disorders (NORD) has announced the full agenda for its 2015 Rare Diseases & Orphan Products Breakthrough Summit, the largest multi-stakeholder event dedicated to rare diseases and the only rare disease conference co-sponsored by the Food and Drug Administration (FDA), to be held October 21-22 at the Crystal Gateway Marriott in Arlington, Virginia.
This annual event is the innovative hub for all stakeholders in the rare disease and orphan products community - providing an educational platform for pharmaceutical, biotech, researchers, patient groups, regulators, healthcare executives and more.
a specialty consulting and contract research organization, and BIOCOM will host "Overcoming Challenges in Orphan Product Development", a special event in support of Rare Disease Day 2014 on February 27 at the Sanford Consortium for Regenerative Medicine in La Jolla, CA.
We are recommending the federal government finally recognize Canada needs a national Orphan Product Policy to set a standard of equality for Canadians with rare and life-threatening conditions.
20, 2015 /PRNewswire/ -- The Dohmen Life Science Services (DLSS) will sponsor the 2015 Rare Diseases & Orphan Products Breakthrough Summit, hosted by the National Organization for Rare Disorders (NORD) October 21-22 at the Crystal Gateway Marriott in Arlington, Virginia.
Food and Drug Administration (FDA), Office of Orphan Products Development, for AIMSPRO for the treatment of systemic sclerosis (scleroderma).
Food and Drug Administration's Office of Orphan Products Development has granted two separate orphan drug designations for its bispecific antibody, MM-111, for the treatment of esophageal cancer and for the treatment of gastric as well as gastroesophageal junction (GEJ)cancers.
Both regulatory agencies require the submission of an annual report for orphan products.
For the past 15 years, funding for the grants program at FDA's Office of Orphan Products Development has remained stagnant at $14 million.