AB Rated definition

AB Rated means “therapeutically equivalent” as evaluated by FDA, applying the definition of “therapeutically equivalent” set forth in the Preface to the current edition of the FDA publication “APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS” (the “Orange Book”), as such requirements may be amended in the future. LICENSE AGREEMENT
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AB Rated means, with respect to any Product, a pharmaceutical product which is an AB-rated equivalent to the Product, as defined in the 22nd edition of Approved Drug Products with Therapeutic Equivalence Evaluations issued by the United States Department of Health and Human Services.
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AB Rated means “therapeutically equivalent” as set forth in the Preface to the current edition of the Orange Book, as such requirements may be amended in the future, as evidenced by the assignment of any ‘A’ rating, such that one pharmaceutical product that is therapeutically equivalent to another pharmaceutical product is generally substitutable by the pharmacist for such other pharmaceutical product when filling a prescription written for such other pharmaceutical product without having to seek authorization to do so from the physician writing such prescription.
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Examples of AB Rated in a sentence

  • For purposes of this Section 7.5.3, a “Generic Product” means a pharmaceutical product that contains the same active ingredient as a Product and that is an AB Rated equivalent (as defined in the 22nd edition of Approved Drug Products with Therapeutic Equivalence Evaluations issued by the United States Department of Health and Human Services) to the Product.

  • Upon RBX’s reasonable determination that a Third Party is expected to launch within six (6) months an AB Rated Product in a country of the Territory, RBX may at such time request [*] launch of its co-marketed product in such country upon exercise of its co-marketing right as set forth in subsection (a) of this Section 3.04.

  • In the event that such AB Rated Product subsequently ceases to be sold or marketed in such country, the reduction of the royalty rate with respect to such Licensed Product in such country under this Section 6.2(c) shall no longer apply, effective with respect to sales of such Licensed Product in such country occurring after the last day on which such AB Rated Product is sold or marketed in such country.

  • In the event that such AB Rated Product subsequently ceases to be sold or marketed in such country, the reduction of the royalty rate with respect to such Licensed Product in such country under this Section 6.3(c) shall no longer apply, effective with respect to sales of such Licensed Product in such country occurring after the last day on which such AB Rated Product is sold or marketed in such country.

  • Sanofi agrees to supply the Carafate® Suspension Product to Purchaser on an exclusive basis in the Territory, and, without limiting the foregoing, shall not supply a sucralfate suspension formulation product that is AB Rated to the Carafate® Suspension Product to any other party in the Territory.

  • From and after the Effective Date until the earlier of termination of this Agreement or the launch of an AB Rated Generic by a Third Party within the Territory, Distributor shall not, and shall cause its Affiliates and SubDistributors to not Market a Competing Product in the Territory.

  • Cephalon shall immediately notify ▇▇▇▇, the Commission, and any Interim Monitor, in writing, upon the occurrence of each of the following events: (i) submission of the NDA for OVF, (ii) receipt of a FDA Approvable Letter for OVF, (iii) Final FDA Approval of OVF, (iv) any determination by the FDA that ACTIQ may no longer be sold in the United States; and (v) any determination by the FDA that ACTIQ is not A/B Rated to ACTIQ SF.

  • In the event that a Third Party launches an AB Rated Generic in the Territory, Distributor may sell an Authorized Generic for use in the Field in the Territory, provided that Distributor pays Can-▇▇▇▇ [...] of Net Profits in the Territory and no other payments other than Transfer Price payments (to the extent Can-▇▇▇▇ is supplying the Authorized Generic) will be due to Can-▇▇▇▇ with respect to such sales.


More Definitions of AB Rated

AB Rated shall have the meaning given to it in the Allegra D-12 Settlement Agreement.
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AB Rated means “therapeutically equivalent” as set forth in the Preface to the current edition of the Orange Book, as such requirements may be amended in the future, as evidenced by the assignment of any ‘A’ rating, such that one pharmaceutical product that is therapeutically equivalent to another pharmaceutical product is generally substitutable by the pharmacist for such other pharmaceutical product when filling a prescription written for such other pharmaceutical product without having to seek authorization to do so from the physician writing such prescription. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential Portions are marked: [***]
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AB Rated means that drugs that have been proven to meet the necessary bioequivalence requirements through in vivo and/or in vitro testing compared to a reference standard that is currently approved. AB is the most common designation. Drugs coded as AB under a specific product heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Thus, products in this category are considered to be generic drugs. However, an AB-rated product may carry an individual brand name. Under no circumstances may an AB-rated generic product use the patented brand name of the reference standard.
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