Authorized Generic definition

Authorized Generic means a Drug Product that is manufactured pursuant to an NDA and Marketed in the United States under a name other than the proprietary name identified in the NDA.

Authorized Generic means a generic product indicated for the treatment of a human for multiple sclerosis that is therapeutically equivalent to, and substitutable for an Infringing Product by orally administering dimethyl fumarate, wherein the therapeutically effective amount of dimethyl fumarate is 480 mg per day, that is (a) sold by or on behalf of Licensee or any of Licensee’s Affiliates, or its or their respective sublicensees, or (b) authorized by Licensee or any of Licensee’s Affiliates or its or their respective sublicensees by license, covenant not to xxx, settlement agreement, release or by any other arrangement or means (including with respect to ANDA filers) (i) for distribution in the U.S. under New Drug Application No. 204063 and/or any and all amendments or supplements thereto; or (ii) for distribution in a Designated Country.

Authorized Generic means any intranasal formulation of dihydroergotamine (other than Migranal) promoted or otherwise commercialized in the Territory by Valeant or its Affiliates, including without limitation, the intranasal dihydroergotamine mesylate product (4mg/mL nasal spray) promoted or otherwise commercialized in the Territory by Oceanside Pharmaceuticals, an Affiliate of Valeant.

Examples of Authorized Generic in a sentence

• Authorized Generic Drugs: Short-Term Effects and Long-Term Impact ii-iii (2011), http://www.ftc.gov/sites/default/files/documents/reports/authorized-generic-drugs-short-term-effects-and-long-term- impact-report-federal-trade-commission/authorized-generic-drugs-short-term-effects-and-long-term-impact-report- federal-trade-commission.pdf (the first generic competitor’s product is typically offered at a 20 to 30 percent discount to the brand product); Fed.

• During the180-day period of market exclusivity, the first-filer only competes against the brand manufacturer and potentially any Authorized Generic (“AG”) marketed under the brand manufacturer’s NDA.

• Yes Yes FOR GENERIC DRUG PRODUCTS Product Shape: Product Color: Product Imprint: N/AN/AN/AAuthorized Generic *If Authorized Generic, other section fields are not applicable Rec.

• From and after the Effective Date until the earlier of (i) the termination of this Agreement, or (ii) a Generic Equivalent becomes available for sale in the Territory, Distributor shall not, and shall cause its Affiliates and SubDistributors to not, Market a Competing Product, other than a Cipher-supplied Authorized Generic, in the Territory.

• The license pursuant to Section 2.1 does not include the right of KU to provide for, market and sell an Authorized Generic or other generic substitute of the V Product (“Generic V Product”), which rights shall be exclusively held by Alkermes.

More Definitions of Authorized Generic

Authorized Generic means a pharmaceutical product that (i) is sold under the Regulatory Approval for a Product or Additional Product, (ii) is sold under a different Trademark than such Product or Additional Product, and (iii) has a National Drug Code (“NDC”) number that differs from the NDC number for such Product or Additional Product (other than on a temporary basis as may be necessary to launch such Product or Additional Product in the applicable market).

Authorized Generic means a Generic Version sold by or on behalf of a party hereto in the Territory, including by an Authorized Generic Distributor, but excluding by any ANDA Settlement Distributor.

Authorized Generic of a Brand-Name Drug means a drug product that: (a) is manufactured pursuant to (i) the NDA for the Brand-Name Drug, or (ii) an ANDA or a 505(b)(2) application for which the Brand-Name Drug is identified as the reference listed drug; and (b) is sold, offered for sale or distributed by—or on behalf of— the holder of the NDA, but not sold or distributed under the proprietary name of the Brand-Name Drug.

Authorized Generic. AG”) drug” means any drug sold, licensed or marketed under an NDA approved by the FDA under 21 U.S.C. § 355(c); and marketed, sold or distributed

Authorized Generic shall have the meaning set forth in Section 6.9(e).

Authorized Generic means a pharmaceutical product that would otherwise satisfy the requirements for a Generic Product under this Agreement, but which (a) is or will be manufactured, sold or otherwise distributed under the Product NDA and is (b) (i) manufactured, sold or otherwise distributed by a Third Party whose operations relating to such pharmaceutical product use rights received, directly or indirectly, from the Buyer pursuant to a license, settlement or other agreement or (ii) otherwise authorized, directly or indirectly, by the Buyer. For the avoidance of doubt, any pharmaceutical product that is manufactured, sold or otherwise distributed under an ANDA shall not be deemed to be an “Authorized Generic”.

Authorized Generic means an unbranded, generic, finished, packaged form version of a Product approved or otherwise authorized for distribution in the Territory under the same applicable Marketing Authorization for the applicable Product.