Marketing Exclusivity means, with respect to each country of the Licensed Territory, the period of data exclusivity as provided under local Laws during which Third Parties do not have the right, in connection with seeking or obtaining Marketing Approval of a pharmaceutical product that contains the same or substantially similar active ingredient(s) or the same active moiety(ies) as a Licensed Product, (i) to reference the Licensed Product’s clinical dossier without an express right of reference from the dossier holder, or (ii) to rely on previous Regulatory Authority determinations of safety and effectiveness with respect to the Licensed Product to support the submission, review or approval of a Drug Approval Application or similar regulatory submission filed with the applicable Regulatory Authority for such pharmaceutical product, as well as any other exclusivity periods available under local Laws (e.g. with respect to orphan drugs, new chemical entity exclusivity and pediatric exclusivity) during which Third Parties are prevented from filing or having accepted by Regulatory Authorities a Drug Approval Application for, or obtaining Marketing Approval of, a pharmaceutical product that contains the same or substantially similar active ingredient(s) or the same active moiety(ies) as a Licensed Product in the relevant country.
Marketing Exclusivity. Marketing Exclusivity means, with respect to a Licensed Product, the marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the FD&C Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the FD&C Act, and the regulations promulgated thereunder, or its equivalent in a country other than the United States.
Marketing Exclusivity means, with respect to a pharmaceutical product in a country: (a) the exclusivity afforded to the pharmaceutical product for being the first drug product containing the active ingredient to receive regulatory approval in that country, (b) pediatric exclusivity, or (c) orphan drug exclusivity, but only when the pharmaceutical product does not also have a non-orphan drug indication that is not protected by an unexpired exclusivity.
Examples of Marketing Exclusivity in a sentence
Valerie Junod, Drug Marketing Exclusivity Under United States and European Union Law, 59 FOOD & DRUG L.J. 479, 484–85 (2004) (noting that marketing-exclusivity periods can encourage the development of unpatentable drugs).
Kcentra® was granted Orphan Drug Marketing Exclusivity for a period of 7 years effective December 2013 based on the approved surgical indication.
With regard to Marketing Exclusivity, IGL has challenged Regulations 5 and 6 of the PNGRB Exclusivity Regulations in the Hon’ble High Court of Delhi and the matter is sub-judice.Your Company has already established the CGD infrastructure across all parts of NCT of Delhi.
Valerie Junod, “Drug Marketing Exclusivity Under United States and European Union Law,” 59 Food and Drug Law Journal (2004), 479; Gerry J.
Marketing Exclusivity As discussed in the May 19, 2015 issue6 of the “FDA/CDER SBIA Chronicles” published by the FDA, upon FDA-NDA approval of a new chemical entity, which for this purpose is defined as a drug that contains no active moiety that has been approved by the FDA in any other FDA-NDA, that drug receives five years of marketing exclusivity during which the FDA cannot approve any abbreviated new drug application seeking approval of a generic version of that drug.
More Definitions of Marketing Exclusivity
Marketing Exclusivity means the marketing exclusivity afforded approved drug products pursuant to (a) the exclusivity provisions of the United States "Drug Price Competition and Patent Term Restoration Act of 1984", or its equivalent in a country other than the United States, or (b) the exclusivity provisions of the United States "Orphan Drug Act", or its equivalent in a country other than the United States.
Marketing Exclusivity means any exclusive marketing, data protection or other exclusivity rights conferred by FDA, EMA or any other Regulatory Authority with respect to the Licensed Product, including orphan drug exclusivity, pediatric exclusivity and rights conferred under the Drug Price Competition and Patent Term Restoration Act of 1984, as amended from time to time.
Marketing Exclusivity. Marketing Exclusivity means, with respect to a Royalty-Bearing Product, that such Royalty-Bearing Product has been granted marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (c) applicable Law covering the Royalty-Bearing Product which precludes the Regulatory Authority in a country from granting Regulatory Approval for another product that contains the same active ingredient as that which is contained in the applicable Royalty-Bearing Product.
Marketing Exclusivity means, with respect to a Licensed Product that the Licensed Product has been granted marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the FD&C Act or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the FD&C Act or its equivalent in a country other than the United States, or (c) applicable law covering the Licensed Product which precludes the Regulatory Authority in a country from granting Marketing Approval for another product that contains the same active ingredient as that which is contained in the applicable Licensed Product.
Marketing Exclusivity means, with respect to a Product in a country: (a) the exclusivity afforded to the Product for being the first drug product containing the active ingredient to receive Regulatory Approval in that country, (b) pediatric exclusivity, (c) orphan drug exclusivity, but only when all other indications of the applicable Product that have been approved by the applicable Regulatory Authority and appear in the labeling for such Product are also protected by an unexpired orphan exclusivity or other exclusivity pursuant to clause (a), (b) or (d) of this Section 1.48, or (d) other statutory and/or regulatory exclusivity.
Marketing Exclusivity means the exclusivity from the purview of common carrier or contract carrier as provided under regulation 6 of the Petroleum and Natural Gas Regulatory Board (Exclusivity for City or Local Natural Gas Distribuition Network) Regulations, 2008.
Marketing Exclusivity. . Marketing Exclusivity means, with respect to a Royalty-Bearing Product, that such Royalty-Bearing Product has been granted marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (c) applicable Law covering the Royalty-Bearing Product which precludes the Regulatory Authority in a country from granting Regulatory Approval for another product that contains the same active ingredient as that which is contained in the applicable Royalty- Bearing Product.