Generic Equivalent Product definition

Generic Equivalent Product means a Competitive Product approved by the FDA.

Generic Equivalent Product means an extended release oral capsule product containing the Compound as its sole active ingredient which is submitted to the FDA for Regulatory Approval pursuant to an ANDA or 505(b)(2) application as a Therapeutic Equivalent to Trokendi XR. For clarity, Generic Equivalent Product shall not include AG Product.

Generic Equivalent Product means any lyophilized pharmaceutical product containing the Compound as its sole active ingredient which is submitted to the FDA for Regulatory Approval pursuant to an ANDA as a Therapeutic Equivalent to Angiomax.

Examples of Generic Equivalent Product in a sentence

• Vertical agrees to do so only when Vertical believes in good faith, based upon credible market information, that a Generic Equivalent Product is on, or is expected to shortly come into, the market in the Territory.

• In cases where it was not possible to sell the house compulsorily due to the lack of a buyer, the house was transferred to state ownership free of charge.15 In such cases, a citizen’s right to property depended on his luck: if there was a buyer, the owner could exercise his right of ownership, and if there was no buyer, the house was confiscated by the state.

• The Contractor shall direct all building maintenance issues (such as doors failing to automatically secure) that may inhibit support of this acquisition to the COR.

• Further meetings were planned and would be reported at the next Board meeting.

• The Generic Equivalent Product Royalty shall automatically become effective as of the Execution Date, and shall automatically terminate on the date the last claim covering Generic Equivalent Products in the Patent expires or is held to be invalid or otherwise unenforceable or is found not to cover Generic Equivalent Products for whatever reason by a court or other legal or administrative tribunal from which no appeal is or can be taken (other than a petition for a writ of certiorari to the Supreme Court).

More Definitions of Generic Equivalent Product

Generic Equivalent Product means a pharmaceutical product that has received FDA approval for marketing in the Territory and is directly substitutable for the Product, including any product that is specified under an Abbreviated New Drug Application (ANDA). CONFIDENTIAL TREATMENT REQUESTED [***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION. EXECUTION VERSION

Generic Equivalent Product means a pharmaceutical product that has received FDA approval for marketing in the Territory and is directly substitutable for the Product, including any product that is specified under an Abbreviated New Drug Application (ANDA).

Generic Equivalent Product means (a) a pharmaceutical product which has been approved by or submitted for approval to FDA under an ANDA as a therapeutic equivalent (as defined in FDA regulations) to AMRIX®, or (b) an Authorized Generic Product.

Generic Equivalent Product means an extended release oral capsule product containing the Compound as its sole active ingredient which is submitted to the FDA for Regulatory Approval pursuant to an ANDA or 505(b)(2) application as a Therapeutic Equivalent to the Trokendi XR Product. For clarity, Generic Equivalent Product shall not include AG Product.

Generic Equivalent Product means a drug product that (a) in the United States, FDA has evaluated as “therapeutically equivalent” to a Product sold by ViroPharma, its Affiliates, or its Sublicensees (as indicated by assignment of a therapeutic equivalence evaluation code beginning with the letter “A” in the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations”); (b) in the European Union, a regulatory authority in the European Union has evaluated as “essentially similar;” or (c) in any country in the Territory outside the United States and the European Union, has a comparable regulatory status or evaluation in terms of a dispensing pharmacist’s ability lawfully to dispense such drug product as a therapeutically equivalent of a Product sold by ViroPharma and its Affiliates or Sublicensees without express permission from the prescriber or the patient.

Generic Equivalent Product means any unbranded prescription 150mg once-daily product containing bupropion hydrochloride for human use that is supplied or manufactured by or for GSK or its Affiliates under a GSK owned or controlled NDA for sale in the United States by or on behalf of GSK (or a Biovail Assignee, if applicable) as a generic equivalent to the 150mg strength of GSK’s Wellbutrin XL® Product. For the avoidance of doubt, Generic Equivalent shall not include (i) any product marketed and sold under GSK’s Wellbutrin XL® trademark (or any other trademark owned or controlled by GSK), or (ii) any Biovail Third Party Licensee Bupropion Product.

Generic Equivalent Product means a pharmaceutical product that (i) is the Therapeutic Equivalent of DUEXIS® or sold as an authorized generic version of ibuprofen (800mg)/famotidine (26.6 mg) tablets that is the subject of, and pursuant to, the DUEXIS NDA and (ii) has been approved for sale in the Territory by the FDA.