Authorized Generics definition

Authorized Generics. Authorized Generics means, with respect to a particular Product being sold in a particular country, a pharmaceutical product that (a) is the same formulation and [*] the applicable Product, (b) is Commercialized by Forest, its Affiliate or a Third Party that has been granted a right to sell such pharmaceutical product by Forest or its Affiliates or Sublicensees under an NDA for such Product for which Forest, its Affiliate or Sublicensee is the applicant, (c) is [*] such Product (as sold by Forest and its Affiliates [*]), and (d) [*] for such Product (other than [*]). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Authorized Generics means any drug sold, licensed, or marketed under the Product’s New Drug Application that is marketed, sold or distributed under a different labeler code, product code, trade name, trademark, or packaging (other than repackaging the listed drug for use in institutions) than the Product.
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Authorized Generics means prescription drugs that are produced by an innovator (i.e., the brand manufacturer) under a New Drug Application (NDA), or licensed to be produced by a generic company under the New Drug Application (NDA), and are marketed, sold and/or distributed as generics under private label. Further, an Authorized Generic is identical to its brand counterpart in dosage form, safety, strength, route of administration, intended use, active and inactive ingredients and, as applicable, size, shape, color, taste, smell and mouth feel.
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Examples of Authorized Generics in a sentence

  • Brian Porter, “Stopping the Practice of Authorized Generics: Mylan’s Effort to Close the Gaping Black Hole in the Hatch-Waxman Act,” 22 Journal of Contemporary Health Law and Policy (2005), 177 (citation omitted).

  • A perspective from our CEO: Gilead Subsidiary to Launch Authorized Generics to Treat HCV.

  • Christopher Worrell, Authorized Generics, presentation given at The 5th Generic Drugs Summit, September 27-29, 2004, and David Reiffen and Michael R.

  • Authorized Generics and Their Evolving Role in Prescription Drug Pricing and Access.

  • IMS Consulting, Assessment of Authorized Generics in the U.S. (2006), http://208.106.226.207/downloads/IMSAuthorizedGenericsReport_6-22-06.pdf.30 One generic stated that “[d]ue to market share and pricing erosion at the hands of the authorized [generic], we estimate that the profits for the ‘pure’ generic during the exclusivity period could be reduced by approximately 60% in a typical scenario.” See FTC 2011 AG Study at 81.

  • Exclude Authorized Generics from Medicaid Brand-Name Rebate Calculations Current LawAuthorized generics are drugs that the original patent holder has licensed to a generic drug manufacturer to sell at a negotiated, reduced price.

  • PHRMA – PhRMA Statement on Authorized Generics, http://www.phrma.org/news_room/press_releases/phrma_state- ment_on_authorized_generics (last visited Nov.

  • John Milligan, “A Perspective from Our CEO: Gilead Subsidiary to Launch Authorized Generics to Treat HCV,” September 24, 2018, https://www.gilead.com/news-and-press/company-statements/authorized-generics-for-hcv.

  • Jon Hess and Elio Evangelista, Authorized Generics: Lifecycle Management’s Compromise in the Patent Wars(Cutting Edge Information, August 23, 2005), 4.

  • Trade Comm’n, Authorized Generic Drugs: Short-Term Effects and Long-Term Impact i-iv (2011), available at http://www.ftc.gov/os/2011/08/2011genericdrugreport.pdf [hereinafter FTC Report on Authorized Generics].

Related to Authorized Generics

  • Authorized aftermarket manufacturer means an organization that fabricates a part under a contract with, or with the express written authority of, the original component manufacturer based on the original component manufacturer’s designs, formulas and/or specifications.

  • Authorized Distributor means a Distributor distributing product within the terms of an Original Component Manufacturer (OCM) or the Original Equipment Manufacturer (OEM) contractual agreement. Contractual Agreement terms include, but are not limited to, distribution region, distribution products or lines, and warranty flow down from the OCM/OEM. Under this distribution, the distributor would be known as an Authorized Distributor. The term Franchised Distributor is considered synonymous with Authorized Distributor.

  • Generic name means a short title which is descriptive of the premium and benefit patterns of a policy or a rider.

  • Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.

  • Authorized Driver means any of the following:

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.

  • Investment product means a financial instrument (within the meaning of Article 4(1)(15) of MiFID II) or a structured deposit (within the meaning of Article 4(1)(43) of MiFID II).

  • Commercial Product means any such product as defined in FAR 2.101.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Authorized Third Party means an entity that:

  • Interchangeable biological product means a biological product that the U.S. Food and Drug Administration has:

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Designated Products means products provided by Motorola to Licensee with which or for which the Software and Documentation is licensed for use.

  • Manufactured products means items and construction materials composed in whole or in part of non-ferrous metals such as aluminum; plastics and polymer-based products such as polyvinyl chloride pipe; aggregates such as concrete; glass, including optical fiber; and lumber.

  • API means American Petroleum Institute.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Generic String means a string consisting of a word or term that denominates or describes a general class of goods, services, groups, organizations or things, as opposed to distinguishing a specific brand of goods, services, groups, organizations or things from those of others.

  • Authorized pharmacist means an Iowa-licensed pharmacist whose license is in good standing and who meets the drug therapy management criteria defined in this rule.

  • NDC means National Drug Code.