Orphan Drug definition

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 drug intended to treat a condition which affects not more than five lakh persons in India;

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

• Additionally, the FDA has granted Orphan Drug Status and a Rare Pediatric Disease Designation to MC-1 for the treatment of PNPO deficiency.

• MDNA55 has secured Orphan Drug Status from the United States Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) as well as Fast Track Designation from the FDA for the treatment of rGBM and other types of high grade glioma.

• Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the United States, or a patient population of 200,000 or greater in the United States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the United States.

• INN-329, secretin, has received Orphan Drug Designation from the FDA.

• On July 5, 2012, KV and Ther-Rx filed a suit against the FDA and HHS in United States District Court for the District of Columbia (the “D.C. District Court”) seeking temporary, preliminary and permanent declaratory and injunctive relief to restore the Company’s right under the Orphan Drug Act to market exclusivity for Makena® (the “FDA Action”).

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 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 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 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 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 drug the FDA has designated as a drug