§ 1111. DEFINITIONS.

503 words·~2 min read·/usc/title-21/section-1111

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

“In this subtitle: The term ‘ANDA’ means an abbreviated drug application, as defined under section 201(aa) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 321(aa) ]. Assistant attorney general .— The term ‘Assistant Attorney General’ means the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice. Biosimilar biological product .— The term ‘biosimilar biological product’ means a biological product for which a biosimilar biological product application under section 351(k) of the Public Health Service Act [ 42 U.S.C. 262(k) ] is approved.

Biosimilar biological product applicant .— The term ‘biosimilar biological product applicant’ means a person who has filed or received approval for a biosimilar biological product application under section 351(k) of the Public Health Service Act [ 42 U.S.C. 262(k) ]. Biosimilar biological product application .— The term ‘biosimilar biological product application’ means an application under section 351(k) of the Public Health Service Act [ 42 U.S.C. 262(k) ] for licensure of a biological product as biosimilar to, or interchangeable with, a reference product.

Brand name drug .— The term ‘brand name drug’ means a drug for which an application is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(c) ], including an application referred to in section 505(b)(2) of such Act [ 21 U.S.C. 355(b)(2) ], or a biological product for which an application is approved under section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ]. Brand name drug company .— The term ‘brand name drug company’ means the party that holds the approved application referred to in paragraph

(6)for a brand name drug that is a listed drug in an ANDA or a reference product in a biosimilar biological product application, or a party that is the owner of a patent for which information is submitted for such drug under subsection

(b)or

(c)of section 505 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(b) , (c)] or the owner, or exclusive licensee, of a patent included in a list provided under section 351( l )(3) of the Public Health Service Act [ 42 U.S.C. 262 ( l )(3)]. Commission .— The term ‘Commission’ means the Federal Trade Commission. Generic drug .— The term ‘generic drug’ means a drug for which an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j) ] is approved. Generic drug applicant .— The term ‘generic drug applicant’ means a person who has filed or received approval for an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j) ]. Listed drug .— The term ‘listed drug’ means a brand name drug that is listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j)(7) ]. Reference product .— The term ‘reference product’ has the meaning given such term in section 351(i) of the Public Health Service Act [ 42 U.S.C. 262(i) ].

Connections5 cite this · traces to 3

Cited by 5 sections · top 4

U.S. Code