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 D—FDA Action on Applications and Abbreviated Applications

21 C.F.R. § 314.108

New drug product exclusivity

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(a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:

Approved under section 505(b) means an NDA submitted under section 505(b) and approved on or after October 10, 1962, or an application that was “deemed approved” under section 107(c)(2) of Public Law 87-781.

Bioavailability study means a study to determine the bioavailability or the pharmacokinetics of a drug.

Clinical investigation means any experiment other than a bioavailability study in which a drug is administered or dispensed to, or used on, human subjects.

Conducted or sponsored by the applicant with regard to an investigation means that before or during the investigation, the applicant was named in Form FDA-1571 filed with FDA as the sponsor of the investigational new drug application under which the investigation was conducted, or the applicant or the applicant's predecessor in interest, provided substantial support for the investigation. To demonstrate “substantial support,” an applicant must either provide a certified statement from a certified public accountant that the applicant provided 50 percent or more of the cost of conducting the study or provide an explanation why FDA should consider the applicant to have conducted or sponsored the study if the applicant's financial contribution to the study is less than 50 percent or the applicant did not sponsor the investigational new drug. A predecessor in interest is an entity, e.g., a corporation, that the applicant has taken over, merged with, or purchased, or from which the applicant has purchased all rights to the drug. Purchase of nonexclusive rights to a clinical investigation after it is completed is not sufficient to satisfy this definition.

Essential to approval means, with regard to an investigation, that there are no other data available that could support approval of the NDA.

New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other NDA submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

New clinical investigation means an investigation in humans the results of which have not been relied on by FDA to demonstrate substantial evidence of effectiveness of a previously approved drug product for any indication or of safety for a new patient population and do not duplicate the results of another investigation that was relied on by the agency to demonstrate the effectiveness or safety in a new patient population of a previously approved drug product. For purposes of this section, data from a clinical investigation previously submitted for use in the comprehensive evaluation of the safety of a drug product but not to support the effectiveness of the drug product would be considered new.

(b) Submission of and timing of approval of a 505(b)(2) application or ANDA. (1) [Reserved]

(2) If a drug product that contains a new chemical entity was approved after September 24, 1984, in an NDA submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act, no person may submit a 505(b)(2) application or ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act for a drug product that contains the same active moiety as in the new chemical entity for a period of 5 years from the date of approval of the first approved NDA, except that the 505(b)(2) application or ANDA may be submitted after 4 years if it contains a certification of patent invalidity or noninfringement described in § 314.50(i)(1)(i)(A)(4) or § 314.94(a)(12)(i)(A)(4).

(3) The approval of a 505(b)(2) application or ANDA described in paragraph (b)(2) of this section will occur as provided in § 314.107(b)(1) or (2), unless the owner of a patent that claims the drug, the patent owner's representative, or exclusive licensee brings suit for patent infringement against the applicant during the 1-year period beginning 48 months after the date of approval of the NDA for the new chemical entity and within 45 days after receipt of the notice described at § 314.52 or § 314.95, in which case, approval of the 505(b)(2) application or ANDA will occur as provided in § 314.107(b)(3).

(4) If an NDA:

(i) Was submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act;

(ii) Was approved after September 24, 1984;

(iii) Was for a drug product that contains an active moiety that has been previously approved in another NDA under section 505(b) of the Federal Food, Drug, and Cosmetic Act; and

(iv) Contained reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the applicant that were essential to approval of the application, for a period of 3 years after the date of approval of the application, the Agency will not approve a 505(b)(2) application or an ANDA for the conditions of approval of the NDA, or an ANDA submitted pursuant to an approved petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act that relies on the information supporting the conditions of approval of an original NDA.

(5) If a supplemental NDA:

(i) Was approved after September 24, 1984; and

(ii) Contained reports of new clinical investigations (other than bioavailability studies) that were conducted or sponsored by the applicant that were essential to approval of the supplemental NDA, for a period of 3 years after the date of approval of the supplemental application, the Agency will not approve a 505(b)(2) application or an ANDA for a change, or an ANDA submitted pursuant to an approved petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act that relies on the information supporting a change approved in the supplemental NDA.

[59 FR 50368, Oct. 3, 1994, as amended at 81 FR 69657, Oct. 6, 2016]
Notes of Decisions
Cited in 33 cases (3 in the last 5 years), 1996–2025 · leading case: Otsuka Pharm. Co. v. Burwell, 302 F. Supp. 3d 375 (D.C. Cir. 2016).
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Otsuka Pharm. Co. v. Burwell, 302 F. Supp. 3d 375 (D.C. Cir. 2016). · cites it 12× “§ 355 (c)(3)(E)(ii) ; see also 21 C.F.R. § 314.108 (b)(2). Similarly, if a manufacturer submits an application for a drug product that contains a previously approved active ingredient, and if certain "new clinical investigations" are included in that application, that…”
Kisor v. Wilkie, 139 S. Ct. 2400 (2019). “21 C.F.R. § 314.108 (a) (2010). Has a company created a new "active moiety" by joining a previously approved moiety to lysine through a non-ester covalent bond? See Actavis Elizabeth LLC v.”
Amarin Pharm. Ireland Ltd. v. Food & Drug Admin., 106 F. Supp. 3d 196 (D.D.C. 2015). · cites it 7× “See 21 C.F.R. § 314.108 . Although the statute refers to a new drug’s “active ingredient,” the regulations do not directly define that term.”
T.H. v. Novartis Pharm. Corp., 407 P.3d 18 (Cal. 2017). “§ 355 (c)(3)(E) ; 21 C.F.R. § 314.108 (b)(2), (4), (5) ); and the higher prices the brand-name drug can continue to command even after the exclusivity period expires.”
Otsuka Pharm. Co., Lt v. Thomas Price, 869 F.3d 987 (D.C. Cir. 2017). · cites it 3× “§ 355 (c)(3)(E)(ii); 21 C.F.R. § 314.108 (a). The statutory reference to a drug’s “active ingredient” captures the drug’s active moiety, which the regulations define as “the .”
In re Egalet Corp., 340 F. Supp. 3d 479 (E.D. Pa. 2018). · cites it 2× “" See 21 C.F.R. § 314.108 (b)(4). ( Id. ¶ 58 ) New drug product exclusivity is granted when a 505(b)(2) NDA: (1) contains an active moiety (a sub-division of a molecule) that has previously received FDA approval; (2) includes new clinical investigations (other than…”
Astrazeneca Pharm. Lp v. Food & Drug Admin., 872 F. Supp. 2d 60 (D.D.C. 2012). · cites it 5× “” 21 C.F.R. § 314.108 (b)(5)(ii). In this case, for example, the FDA has granted AstraZeneca exclusivity over two pediatric indications for Seroquel until December 2, 2012.”
Ferring Pharm., Inc. v. Burwell, 169 F. Supp. 3d 199 (D.D.C. 2016). · cites it 4× “21 C.F.R. § 314.108 (b)(2). The regulation further defines several of these terms.”
Braeburn Inc. v. U.S. Food & Drug Admin., 389 F. Supp. 3d 1 (D.C. Cir. 2019). · cites it 3× “By regulations not challenged here, the FDA has expanded on the meaning of certain terms in the eligibility clause, namely: "active ingredient" has been construed to mean "active *8 moiety," 21 C.F.R. § 314.108 (b)(4)(iii), 3 and "new clinical investigation" has been defined to…”
Astrazeneca Pharm. Lp v. Food & Drug Admin., 850 F. Supp. 2d 230 (D.D.C. 2012). · cites it 3× “” 21 C.F.R. § 314.108 (b)(5)(h). 4. Tentative and Final Approval of ANDAs When the FDA first receives an ANDA from a potential generic competitor, it makes the threshold determination of whether the application should even be accepted for processing, which simply requires that…”
Eisai Inc. v. United States Food & Drug Admin., 134 F. Supp. 3d 384 (D.D.C. 2015). · cites it 17× “” 21 C.F.R. § 314.108 (b)(2). “Date of approval,” in turn, is defined as: the date on the letter from FDA stating that the new drug application is approved, whether or not final printed labeling or other materials must yet be submitted as long as approval of such labeling or…”
In re Relafen Antitrust Litig., 221 F.R.D. 260 (D. Mass. 2004). “See 21 C.F.R. 314.108 (providing a period of exclusive FDA approval for “new drug products” — such as Relafen).”
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— 21 C.F.R. § 314.108(a) — 1 case
Vanda Pharm., Inc. v. Centers for Medicare & Medicaid Servs. (D. Maryland 2023).
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