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RxOutlook4th Quarter 2017OptumRx brand pipeline forecast
Drug nameGeneric nameCompanyDrug classTherapeutic reroute of
administrationRegulatory
statusEstimated
release dateSpecialty Orphan
drug
drug2017
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What is specialty orphan?
Specialty orphan is a designation given to certain drugs that treat rare diseases or conditions affecting a small number of people.
Who is required to file specialty orphan?
Drug manufacturers or sponsors are required to file for specialty orphan designation with the regulatory authorities.
How to fill out specialty orphan?
To fill out a specialty orphan application, the drug manufacturer or sponsor must provide detailed information about the drug, disease, patient population, and evidence of the drug's efficacy.
What is the purpose of specialty orphan?
The purpose of specialty orphan designation is to incentivize the development of drugs for rare diseases by providing benefits such as market exclusivity, tax credits, and regulatory fee waivers.
What information must be reported on specialty orphan?
Information such as the drug's name, intended use, disease prevalence, mechanism of action, and clinical data must be reported on the specialty orphan application.
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