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 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.

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.

Examples of Authorized Generic in a sentence

• FDA Application Number/OTC Monograph Number: For drugs with a COD status of ANDA, BLA, NDA, or NDA Authorized Generic, this is the application number (assigned by the FDA for approval to market a drug or biological in the United States) under which the NDC is currently marketed.

• The License Agreement defines “Generic Equiva- lent” to mean “a pharmaceutical product that has received FDA approval for marketing in the Territory pursuant to an ANDA approved pursuant to 21 U.S.C. § 355(G) or an application under 21 U.S.C. § 355(b)(2), each as an AB- rated generic version of the Colcrys product for which Col- crys is the Reference Listed Drug and which is covered by the Takeda NDAs, but excluding any Authorized Generic Product.” J.A. 104.TAKEDA PHARMACEUTICALS U.S.A. v.

• Ass’n to FTC on Authorized Generic Drug Study (June 27, 2006), http://www.ftc.gov/os/comments/genericdrugstudy3/062806gpha.pdf 6130 Cong.

• Shapiro, Sonecon, The Impact of Authorized Generic Pharmaceuticals on the Introduction of Other Generic Pharmaceuticals 3 (2007), http://www.

• 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.

More Definitions of Authorized Generic

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 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. 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 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 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 sue, 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 a pharmaceutical product that is manufactured, sold, offered for sale or distributed pursuant to NDA No. 205388 but is not sold under the trade name OMIDRIA® or another trade name or trademark owned by Omeros or its Affiliates.