C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart B—Applications

21 C.F.R. § 314.54

Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug

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(a) The Federal Food, Drug, and Cosmetic Act does not permit approval of an ANDA for a new indication, nor does it permit approval of other changes in a listed drug if investigations, other than bioavailability or bioequivalence studies, are essential to the approval of the change. Any person seeking approval of a drug product that represents a modification of a listed drug (e.g., a new indication or new dosage form) and for which investigations, other than bioavailability or bioequivalence studies, are essential to the approval of the changes may, except as provided in paragraph (b) of this section, submit a 505(b)(2) application. This 505(b)(2) application need contain only that information needed to support the modification(s) of the listed drug.

(1) The applicant must submit a complete archival copy of the application that contains the following:

(i) The information required under § 314.50(a), (b), (c), (d)(1), (d)(3), (e), and (g), except that § 314.50(d)(1)(ii)(c) must contain the proposed or actual master production record, including a description of the equipment, to be used for the manufacture of a commercial lot of the drug product.

(ii) The information required under § 314.50 (d)(2), (d)(4) (if an anti-infective drug), (d)(5), (d)(6), and (f) as needed to support the safety and effectiveness of the drug product.

(iii) Identification of each listed drug for which FDA has made a finding of safety and effectiveness and on which finding the applicant relies in seeking approval of its proposed drug product by established name, if any, proprietary name, dosage form, strength, route of administration, name of listed drug's application holder, and listed drug's approved NDA number. The listed drug(s) identified as relied upon must include a drug product approved in an NDA that:

(A) Is pharmaceutically equivalent to the drug product for which the original 505(b)(2) application is submitted; and

(B) Was approved before the original 505(b)(2) application was submitted.

(iv) If the applicant is seeking approval only for a new indication and not for the indications approved for the listed drug on which the applicant relies, a certification so stating.

(v) Any patent information required under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act with respect to any patent which claims the drug for which approval is sought or a method of using such drug and to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product.

(vi) Any patent certification or statement required under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act with respect to any relevant patents that claim the listed drug(s) on which investigations relied on by the applicant for approval of the application were conducted, or that claim a use for the listed drug(s). A 505(b)(2) applicant seeking approval of a drug that is pharmaceutically equivalent to a listed drug approved in an NDA implicitly relies upon one such pharmaceutically equivalent listed drug.

(vii) If the applicant believes the change for which it is seeking approval is entitled to a period of exclusivity, the information required under § 314.50(j).

(2) The applicant must submit a review copy that contains the technical sections described in § 314.50(d)(1), except that the section described in § 314.50(d)(1)(ii)(c) must contain the proposed or actual master production record, including a description of the equipment, to be used for the manufacture of a commercial lot of the drug product, and § 314.50(d)(3), and the technical sections described in § 314.50(d)(2), (d)(4) through (6), and (f) when needed to support the modification. Each of the technical sections in the review copy is required to be separately bound with a copy of the information required under § 314.50(a), (b), and (c) and a copy of the proposed labeling.

(3) The information required by § 314.50 (d)(2), (d)(4) (if an anti-infective drug), (d)(5), (d)(6), and (f) for the listed drug on which the applicant relies must be satisfied by reference to the listed drug under paragraph (a)(1)(iii) of this section.

(4) The applicant must submit a field copy of the 505(b)(2) application that contains the technical section described in § 314.50(d)(1), a copy of the information required under § 314.50(a) and (c), and certification that the field copy is a true copy of the technical section described in § 314.50(d)(1) contained in the archival and review copies of the 505(b)(2) application.

(b) A 505(b)(2) application may not be submitted under this section for a drug product whose only difference from a listed drug is that:

(1) The extent to which its active ingredient(s) is absorbed or otherwise made available to the site of action is less than that of the listed drug; or

(2) The rate at which its active ingredient(s) is absorbed or otherwise made available to the site of action is unintentionally less than that of the listed drug.

[57 FR 17982, Apr. 28, 1992; 57 FR 61612, Dec. 28, 1992, as amended at 58 FR 47351, Sept. 8, 1993; 59 FR 50364, Oct. 3, 1994; 81 FR 69647, Oct. 6, 2016]
Notes of Decisions
Cited in 11 cases (3 in the last 5 years), 2000–2025 · leading case: Fed. Trade Comm'n v. AbbVie Inc, 976 F.3d 327 (3rd Cir. 2020).
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Fed. Trade Comm'n v. AbbVie Inc, 976 F.3d 327 (3rd Cir. 2020). “” 21 C.F.R. § 314.54 (a). The latter two pathways “speed the introduction of low- cost generic drugs to market” and promote competition in the pharmaceutical industry.”
Ethypharm S.A. France v. Abbott Labs., 707 F.3d 223 (3rd Cir. 2013). “See 21 C.F.R. § 314.54 (a) (providing that § 505(b)(2) applications must provide data that supports any modification of the drug from the relied upon NDA).”
Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000). · cites it 2× “See 21 C.F.R. §§ 314.54 , 314.70-.71 (1999); Washington Legal Found.”
Sanofi-Aventis U.S. LLC v. Food & Drug Admin., 842 F. Supp. 2d 195 (D.D.C. 2012). · cites it 4× “FDA’s approach is consistent with 21 C.F.R. § 314.54 (a), *211 which applies the 355(b) pathway for “[a]ny person seeking approval of a drug product that represents a modification of a listed drug (e.”
Takeda Pharm., U.S.A., Inc. v. Burwell, 78 F. Supp. 3d 65 (D.D.C. 2015). · cites it 2× “Additionally, any 505(b)(2) NDA that is submitted to FDA for approval must identify the previously approved drug that the applicant is relying upon for approval, see 21 C.F.R. § 314.54 , and must contain certain statements (“certifications”) regarding any “product patents”…”
UFCW Local 1776 & Participating Employers Health & Welfare Fund v. Eli Lilly & Co., 253 F.R.D. 69 (E.D.N.Y 2008). “§§ 360aaa(b), (c); see also 21 C.F.R. § 314.54 (outlining the administrative procedure for filing an application for a new indication); 21 U.”
In Re: Lantus Direct Purchaser v. (1st Cir. 2020). “§ 355 (b)(2); 21 C.F.R. § 314.54 (a)(1)(iii). In its application, the aspiring competitor must certify for each patent listed in the Orange Book for the original drug that (1) the patent has expired, (2) the competing manufacturer will wait for the patent to expire before…”
Fed. Trade Comm'n v. AbbVie Inc (3rd Cir. 2020). “” 21 C.F.R. § 314.54 (a). The latter two pathways “speed the introduction of low- cost generic drugs to market” and promote competition in the pharmaceutical industry.”
Perrigo Co v. AbbVie Inc (3rd Cir. 2022). “§ 355 (b)(2); 21 C.F.R. § 314.54 (a). Under that section, the generic manufacturer must submit a paragraph IV notice in which it certifies that “manufacture, 2 § 355(b)(2)(A)(iv), Plaintiffs sent Defendants a “paragraph IV notice[],” which stated that the 1% generic does not…”
Perrigo Co. v. Abbvie, Inc. (D.N.J. 2021). “2020); see also 21 C.F.R. § 314.54 (a) (providing that examples of a brand-name drug modification may include “a new indication or new dosage form”).”
In Re Selenious Acid Litig. (D.N.J. 2025). “A Section 505(b)(2) NDA “is like an ANDA because the company need not produce all safety and efficacy data about the drug and because it must assure the FDA that its generic drug will not infringe the brand’s patents,” but differs “because the company must produce some data,…”
— 21 C.F.R. § 314.54(a) — 1 case
Takeda Pharm., U.S.A., Inc. v. Burwell, 78 F. Supp. 3d 65 (D.D.C. 2015). “Additionally, any 505(b)(2) NDA that is submitted to FDA for approval must identify the previously approved drug that the applicant is relying upon for approval, see 21 C.F.R. § 314.54 , and must contain certain statements (“certifications”) regarding any “product patents”…”
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