Authorized Generics definition

Authorized Generics means, with respect to a particular Product being sold in a particular country, a pharmaceutical product that (a) is the same formulation and [*] the applicable Product, (b) is Commercialized by Forest, its Affiliate or a Third Party that has been granted a right to sell such pharmaceutical product by Forest or its Affiliates or Sublicensees under an NDA for such Product for which Forest, its Affiliate or Sublicensee is the applicant, (c) is [*] such Product (as sold by Forest and its Affiliates [*]), and (d) [*] for such Product (other than [*]). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Authorized Generics means any drug sold, licensed, or marketed under the Product’s New Drug Application that is marketed, sold or distributed under a different labeler code, product code, trade name, trademark, or packaging (other than repackaging the listed drug for use in institutions) than the Product.

Authorized Generics means prescription drugs that are produced by an innovator (i.e., the brand manufacturer) under a New Drug Application (NDA), or licensed to be produced by a generic company under the New Drug Application (NDA), and are marketed, sold and/or distributed as generics under private label. Further, an Authorized Generic is identical to its brand counterpart in dosage form, safety, strength, route of administration, intended use, active and inactive ingredients and, as applicable, size, shape, color, taste, smell and mouth feel.

Examples of Authorized Generics in a sentence

• Authorized Generics and Their Evolving Role in Prescription Drug Pricing and Access.

• In the event Forest, either by itself or through its Affiliates or Sublicensees, Commercializes one (1) or more products that are Authorized Generics with respect to a Product, then Forest shall pay to Adamas royalties on the Net Sales of such Authorized Generics in an amount [*].

• Patient and Payer Incentives to Use On-Patent Brand-Name Drugs Over Authorized Generics in Medicare Part D.

• A perspective from our CEO: Gilead Subsidiary to Launch Authorized Generics to Treat HCV.

• See SCHACHT & THOMAS, supra note 106, at 4 (“If, prior to the expiration of 30 months, the court holds that the patent is invalid or would not be infringed, then the FDA will approve the ANDA when that decision occurs.”); see also Beth Understahl, Note, Authorized Generics: Careful Balance Undone, 16 FORDHAM INTELL.

• PHRMA – PhRMA Statement on Authorized Generics, http://www.phrma.org/news_room/press_releases/phrma_state- ment_on_authorized_generics (last visited Nov.

• The final rule revises proposed§ 314.81(b)(2)(ii)(b) to allow NDA holders to send the required information to the Authorized Generics electronic mailbox at AuthorizedGenerics@fda.hhs.gov with ‘‘Authorized Generic Submission’’ indicated in the subject line.We also revised the last line of thatsection to clarify when separate submission of the authorized generics information is required by this rule.

• In its June 2009 Authorized Generics Report,79 the FTC examined the short-term effects of authorized generics during the initial period of generic competition (the 180-day marketing exclusivity period).

• Thomas Chen, Note, Authorized Generics: A Pre- scription for Hatch-Waxman Reform, 93 VA.

• The final rule revises proposed§ 314.81(b)(2)(ii)(b) to allow NDA holders to send the required information to the Authorized Generics electronic mailbox at AuthorizedGenerics@fda.hhs.gov with ‘‘Authorized Generic Submission’’ indicated in the subject line.We also revised the last line of that section to clarify when separate submission of the authorized generics information is required by this rule.