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 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.

Examples of Authorized Generic in a sentence

• Members requiring any information on the Accounts are requested to write to the Company at least one week before the meeting so as to enable the Management to keep the information ready, replies will be provided only at the meeting.

• 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.

• 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.

• Because it found no protectable contract right, the Court also held Mylan‘s claims against Apotex necessarily failed; this meant that GSK and Apotex were entitled to judgment as a matter of law on all claims brought by Mylan.On appeal, Mylan challenges the District Court‘s interpretation of the Authorized Generic Clause and its consequent grant of summary judgment in favor of (i) GSK on Mylan‘s contractual claims, and (ii) Apotex with respect to Mylan‘s tortious interference claim.6 II.

More Definitions of Authorized Generic

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

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 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 means an authorized generic version of a Licensed Product that is Manufactured by or on behalf of Sanofi, its Affiliate or its Sublicensee or a Third Party designated by Sanofi or its Affiliate or Sublicensee.