Generic Equivalent Product definition

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 as a Therapeutic Equivalent to the Trokendi XR Product. For clarity. Generic Equivalent Product shall not include AG Product.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

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

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).

Examples of Generic Equivalent Product in a sentence

If a Generic Equivalent Product is sold commercially in the Territory and then subsequently withdrawn, with no other Generic Equivalent Product being sold commercially in the Territory, then Vertical will, in good faith and without undue delay, once again comply with the foregoing Minimum Promotion Commitment as soon as is it practical to do so.
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.
Nothing set forth herein or in the other Settlement Documents shall be deemed to prevent or restrict Actavis from Manufacturing or Marketing any Generic Equivalent Product which would not infringe the Licensed Patents, and nothing herein shall prohibit Actavis from entering into any agreement with a Third Party related to any Generic Equivalent Product that does not infringe the Licensed Patents.
Notwithstanding the foregoing, nothing in this Agreement precludes Actavis from (y) maintaining and/or (e.g., in the case of a recertification pursuant to 21 C.F.R.§ 314.96(d)) filing Paragraph IV certifications with respect the Actavis ANDA against the Licensed Patents, or (z) challenging the validity, enforceability and/or infringement of the Licensed Patents in connection with another ANDA or ANDA product owned or sold by Actavis that is not seeking Regulatory Approval of a Generic Equivalent Product.
Actavis and its Affiliates acknowledge that in the event of a launch or continued Marketing or Shipping by Actavis or its Affiliates of Actavis Product or any other Generic Equivalent Product in the Territory other than as permitted under this License Agreement, the damages to Supernus and its business (including, but not limited to, lost sales of Trokendi XR) would be difficult to calculate and the adequacy of monetary damages calculated at Law would be uncertain.
Subject to the remainder of this Section 3.10, Teva hereby agrees that Teva shall not supply the Compound to any Third Party which Teva knows or has reason to know will be used to Manufacture a Generic Equivalent Product that is intended for Marketing or use in the Territory.
In addition to any other right or remedy MDCO may be entitled to, in the event that (i) Teva breaches this Section 3.10, or (ii) Compound supplied by Teva is used in a Generic Equivalent Product sold in the Territory by a Third Party [**] prior to: [**], MDCO may, at its sole discretion, immediately, effective upon notice to Teva, terminate the API Supply Agreement and/or this Agreement.
Apotex and its Affiliates acknowledge that in the event of an Apotex Launch or continued Marketing or Shipping by Apotex or its Affiliates of Apotex Product or any other Generic Equivalent Product in the Territory other than as permitted under this License Agreement, the damages to Supernus and its business (including, but not limited to, lost sales of the Oxtellar XR Product) would be difficult to calculate and the adequacy of monetary damages calculated at Law would be uncertain.
Notwithstanding the foregoing, nothing herein shall prohibit Ascent from asserting any and all counterclaims or defenses of invalidity, non-infringement, or unenforceability of the Litigated Patents in any proceeding the subject matter of which is not the Ascent Product or a Generic Equivalent Product or products subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug (and Ascent may file a petition for ex parte reexamination.
Nothing herein shall prevent Ascent from filing or maintaining any Paragraph IV Certification with respect to any Litigated Patent or any other patent listed in the Orange Book in connection with any product which is not the Ascent Product or a Generic Equivalent Product or products subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug.

More Definitions of Generic Equivalent 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 Trokendi XR. For clarity, Generic Equivalent Product shall not include AG Product.

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 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.

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.