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
In the event that Xxxxx notifies Collegium that Xxxxx intends to launch its own Generic Equivalent of either Product pursuant to Section 2.3(d), then this Agreement shall terminate in its entirety effective upon the expiration of the Sell-Off Period for such Product.
Notwithstanding the foregoing, Hikma will not have the right to Market either Product, including during the Sell-Off Period, at the same time it is selling its own Generic Equivalent of either Product.
More Definitions of Generic Equivalent
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 a pharmaceutical product that is Marketed or intended for Marketing in the Territory pursuant to an approved ANDA as an A-rated generic equivalent to any of the NDA Products.
Generic Equivalent means an A/B rated (as the term is used by the FDA) generic version of the Product.
Generic Equivalent means a pharmaceutical product that receives approval for Commercialization pursuant to an ANDA in the applicable portion of the Covered Territory.
Generic Equivalent or "generically equivalent" means a drug that
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 means any product with the same active ingredient and route of administration as a Licensed Product.