Orphan Drug means a drug intended to treat a condition which affects not more than five lakh persons in India;
Orphan Drug means a drug or biologic that meets the definition for “orphan drug” provided in 21 C.F.R. § 316.3(b)(10) that has been granted an orphan drug designation by the Secretary of U.S. Department of Health and Human Services under 21 U.S.C. § 360bb, and any foreign equivalents.
Orphan Drug means a Licensed Product that is protected (a) by “Orphan Drug” status under the U.S. Orphan Drug Act, (b) by a Supplementary Protection Certificate, as such term is defined in Council Regulation (EU) No. 1768/92, or (c) by a similar status granted under similar statutory provisions of another jurisdiction granting exclusive marketing rights in such jurisdiction.
Examples of Orphan Drug in a sentence
While there is no guarantee that the pending applications or future pending claims will issue, the issued US patent will provide protection of JAN123 through 2040 and the Orphan Drug Designation provides 7 years of market exclusivity after drug approval in the event that there are any challenges to this patent.
Prior to the acquisition, Soin Therapeutics received Orphan Drug Designation for the product, which provides a variety of incentives for developing the product in this indication.
More Definitions of Orphan Drug
Orphan Drug means (a) a pharmaceutical product intended to treat a disease or condition that affects fewer than 200,000 people in the United States or, if the pharmaceutical product is a vaccine, diagnostic product, or preventive product, the persons to whom such product will be administered in the United States are fewer than 200,000 per year, or (b) a pharmaceutical product intended to treat a disease or condition that affects 200,000 or more people in the United States, but with respect to which product there is no reasonable expectation that the costs of research and development of such product to treat such disease or condition can be recovered by sales of such product in the United States.
Orphan Drug means a drug intended for use in a rare disease or condition as defined by the Orphan Drug Act.
Orphan Drug means a Licensed Product for a specific indication for which the FDA has granted “Orphan-drug exclusive approval” as defined in 21 CFR Paid 316 or which be granted Orphan Drug exclusivity under similar regulations in the European Union or Japan.
Orphan Drug means a Product that has been designated by the United States Food and Drug Administration pursuant to the Orphan Drug Act as a drug for a specified rare disease or condition.
Orphan Drug means a drug intended to treat a condition which affects not more than five lakh persons in India;Post-trial Access
Orphan Drug means a product that is used to treat disease that affects relatively few people and for which U.S. and foreign government authorities or agencies provide tax credits or other incentives to make it possible to provide a safe and effect medical product for the treatment of the disease.
Orphan Drug. Status" is an exclusive approval to market a therapeutic for the treatment of a human fibrotic disease based upon orphan drug status under the Orphan Drug Act of 1983 in the United States (Pub.L. 97-414, Jan.4, 1983, 96 Stat. 2049) or any corresponding or similar non-U.S. statutes, granted by the U.S. Food and Drug Administration ("FDA"), the Committee on Proprietary Medicinal Products ("CPMP") or other Regulatory Agencies in the Territory to InterMune for the anti-fibrotic uses of Pirfenidone for such disease.