Generic Equivalent definition

Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

Generic Equivalent means ***.

Generic Equivalent means any (i) biosimilar of a Product or (ii) any product with the same active ingredient as a Product.

Examples of Generic Equivalent in a sentence

• When a Generic Equivalent is available, the Plan will only cover the cost of the Generic equivalent.

• The Department of Health has determined that a drug shall not be recognized as an A-rated generic therapeutically equivalent drug for purpose of substitution under section 5(b) of the act of November 24, 1976 (P.L.1163, No.259), referred to as the Generic Equivalent Drug Law.

• Members may still obtain the Brand version of a Drug, but the Plan will only reimburse based on the cost of the Generic Equivalent if there is one available (even when a doctor requests no substitutes).

• Prescription Drug copayments*, coinsurance* and deductibles* (*if applicable) apply to the Out-of-Pocket limit.MAC B Pricing (Brand Penalty when Generic Equivalent is available and Provider does not require Brand to be dispensed).

• In the event that, during the term of the Licensed Patents and without Sanofi’s permission, any Defendant in the Consolidated Eloxatin Patent Litigation sells a generic version of a Sanofi NDA Product in the Territory prior to a Final Court Decision (“At-Risk Launch”), Sun will have the option of selling its Generic Equivalent prior to the Launch Date.

More Definitions of Generic Equivalent

Generic Equivalent means a pharmaceutical product that has received FDA approval for marketing in the Territory pursuant to an ANDA (or equivalent regulatory mechanism) as a generic equivalent to the AMITIZA® Products.

Generic Equivalent means a drug that is designated to be therapeutically equivalent, as indicated by the U.S. Food and Drug Administration’s publication Approved Drug Products with Therapeutic Equivalence Evaluations.

Generic Equivalent means an A/B rated (as the term is used by the FDA) generic version of the Product.

Generic Equivalent means any other pharmaceutical product that is an FDA AB-rated (or its foreign equivalent) generic version of a Product in the Territory, or a pharmaceutical product with the same Active Material (or therapeutically equivalent, bioequivalent, biosimilar and legally substitutable or interchangeable Active Material(s) thereto) and labeled indication(s) as a Product. A product produced by or on behalf of or authorized by Client, its Affiliates or licensors or any other authorized generic product will not constitute a Generic Equivalent.

Generic Equivalent or "generically equivalent" means a drug that

Generic Equivalent means any product with the same active ingredient and route of administration as a Licensed Product.

Generic Equivalent means a generic pharmaceutical product that is therapeutically equivalent to the Innovator Product, where “therapeutically equivalent” means: an AB rating is assigned to such product’s entry in the list of drug products with effective approvals published in the then-current edition of FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” and any current supplement to the publication (also known as the “Orange Book”) referred to in 21 C.F.R. 314.3 and such product is covered by an ANDA.