Therapeutic Equivalent definition

Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.
Therapeutic Equivalent shall have the meaning given to it by the FDA in the current edition of the Orange Book as may be amended from time to time during the Term.
Therapeutic Equivalent means a drug which:

Examples of Therapeutic Equivalent in a sentence

  • Efforts to develop a stable final dosage form of the Product, such that each dosage strength thereof shall be a Therapeutic Equivalent of the respective strength of the Brand Product as listed in the Orange Book as of the Effective Date, according to a proposed timetable to be agreed to by the Development Committee (as defined below) within thirty (30) days of the Effective Date.

  • In the event lntelGenx successfully completes a [***] is a Therapeutic Equivalent to a branded pharmaceutical product (the "[***]"), IntelGenx shall promptly provide Par with written notice thereof.

  • In the event IntelGenx successfully completes a Pilot Bioequivalence Study for a Drug Product that is a Therapeutic Equivalent to the [***], as may be amended or supplemented from time to time (the “[***]”), IntelGenx shall promptly provide Par with written notice thereof.

  • Pfenex and Alvogen Expand Development and Commercialization Collaboration for PF708, a Therapeutic Equivalent Candidate to Forteo®/Forsteo®, to the EU, MENA, and ROW Distribution and Promotion by established regional players Theramex and Tamer Group (SAJA) —— SAN DIEGO, February [XX], 2019 — Pfenex Inc.

  • IPC agrees that during the term of this Agreement it will not by itself, and will not enable or contract with any third party to, market, sell or distribute any Product or Therapeutic Equivalent to the Brand Product to third parties for distribution or sale in the Territory or work on the development of any Product or Therapeutic Equivalent to the Brand Product for sale in the Territory, except for the development of the Product in co-operation with Par as provided for in this Agreement.


More Definitions of Therapeutic Equivalent

Therapeutic Equivalent has the meaning given to it by the FDA in the current edition of the “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) as may be amended from time to time.
Therapeutic Equivalent means a drug product that is classified by the FDA as being therapeutically equivalent to another drug product.
Therapeutic Equivalent means prescription drug products that, when compared, can be expected to produce essentially the same therapeutic outcome and toxicity as determined by the Insurer.
Therapeutic Equivalent means a contraceptive drug, device, or product that is all of the following:
Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity. ❖ “Therapeutic Supply” is the maximum quantity of supplies for which benefits are available for a single applicable Copayment or Coinsurance amount, if applicable, and may be less than but shall not exceed a thirty (30)-day supply.
Therapeutic Equivalent means a drug product that is classified by the FDA as being therapeutically equivalent to another drug product or that otherwise meets the FDA’s criteria for such classification.
Therapeutic Equivalent means a drug, device or other