US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 360cc

Protection for drugs for rare diseases or conditions

(a)

Exclusive approval, certification, or license

Except as provided in subsection (b), if the Secretary—
(1)
section 355 of this title approves an application filed pursuant to , or
(2)
section 262 of title 42 issues a license under
section 360bb of this titlesection 355 of this titlesection 262 of title 421
1 See References in Text note below.
for a drug designated under for a rare disease or condition, the Secretary may not approve another application under or issue another license under for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2)  of this title does not apply to the refusal to approve an application under the preceding sentence.
(b)

Exceptions

section 355 of this titlesection 262 of title 42During the 7-year period described in subsection (a) for an approved application under or license under , the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if—
(1)
the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or
(2)
the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.
(c)

Condition of clinical superiority

(1)

In general

section 360bb of this titleIf a sponsor of a drug that is designated under and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.

(2)

Definition

For purposes of paragraph (1), the term “clinically superior” with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.

(3)

Applicability

section 360bb of this titlesection 355 of this titlesection 262 of title 42section 360bb of this titleThis subsection applies to any drug designated under for which an application was approved under or licensed under after , regardless of the date on which such drug was designated under .

(d)

Regulations

The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on , until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.

(e)

Demonstration of clinical superiority standard

To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—
(1)
section 360bb of this title upon the designation of any drug under , shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and
(2)
upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.

June 25, 1938, ch. 675, § 527Pub. L. 97–414, § 2(a)96 Stat. 2050Pub. L. 98–417, title I, § 102(b)(6)98 Stat. 1593Pub. L. 99–9199 Stat. 387Pub. L. 103–80, § 3(v)107 Stat. 778Pub. L. 105–115, title I, § 125(b)(2)(J)111 Stat. 2326Pub. L. 107–281, § 4116 Stat. 1993Pub. L. 115–52, title VI, § 607(a)131 Stat. 1049Pub. L. 116–260, div. BB, title III, § 323134 Stat. 2933(, as added , , ; amended , , ; , §§ 2, 3(a)(3), , , 388; , , ; , (K), , ; , , ; , , ; , , .)

Editorial Notes

References in Text

Section 355(c)(2) of this titlesection 355(c)(1)(B) of this titlePub. L. 98–417, title I, § 102(a)(2)98 Stat. 1592, referred to in subsec. (a), was redesignated as by , , .

Pub. L. 115–52This section, as amended by such Act, referred to in subsec. (d), means this section as amended by the FDA Reauthorization Act of 2017, .

Amendments

Pub. L. 116–2602020—Subsec. (c)(3). added par. (3).

Pub. L. 115–52, § 607(a)(1)2017—Subsec. (a). , substituted “the same drug for the same disease or condition” for “such drug for such disease or condition” in concluding provisions.

Pub. L. 115–52, § 607(a)(2)(A)section 355 of this titlesection 262 of title 42section 355 of this titlesection 360bb of this titlesection 262 of title 42section 355 of this titlesection 262 of title 42Subsec. (b). , in introductory provisions, substituted “During the 7-year period described in subsection (a) for an approved application under or license under , the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if” for “If an application filed pursuant to is approved for a drug designated under for a rare disease or condition or if a license is issued under for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under or issue a license under , for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if”.

Pub. L. 115–52, § 607(a)(2)(B)Subsec. (b)(1). , substituted “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure” for “notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure”.

Pub. L. 115–52, § 607(a)(2)(C)Subsec. (b)(2). , substituted “the holder provides” for “such holder provides”.

Pub. L. 115–52, § 607(a)(3)Subsecs. (c) to (e). , added subsecs. (c) to (e).

Pub. L. 107–2812002—Subsec. (a). , in concluding provisions, struck out “, of such certification,” after “such approved application” and “, the issuance of the certification,” after “approval of the approved application”.

Pub. L. 105–115, § 125(b)(2)(J)section 357 of this titlesection 357 of this title1997—Subsec. (a). , struck out “, issue another certification under ,” before “or issue another license” in closing provisions, inserted “or” at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: “issues a certification under , or”.

Pub. L. 105–115, § 125(b)(2)(K)section 357 of this titlesection 357 of this titlesection 357 of this titlesection 355 of this titleSubsec. (b). , in introductory provisions, struck out “, if a certification is issued under for such a drug,” after “rare disease or condition”, “, of the issuance of the certification under ,” after “application approval”, “, issue another certification under ,” after “application under ”, and “, of such certification,” after “approved application”.

Pub. L. 105–115, § 125(b)(2)(K)Subsec. (b)(1). , struck out “, of the certification,” after “holder of the approved application”.

Pub. L. 105–115, § 125(b)(2)(K)Subsec. (b)(2). , struck out “, issuance of other certifications,” after “approval of other applications”.

Pub. L. 103–801993—Subsec. (b). struck out extraneous comma before “or issue a license under section 262” in introductory provisions and substituted “the” for “The” at beginning of par. (1).

Pub. L. 99–91, § 2(3)1985—, struck out “unpatented” before “drugs” in section catchline.

Pub. L. 99–91section 357 of this titlesection 355 of this titleSubsec. (a). , §§ 2(1), 3(a)(3)(A)–(D), struck out “or” at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out “and for which a United States Letter of Patent may not be issued” after “rare disease or condition”, inserted in first sentence “, issue another certification under ,” after “” the second time it appeared, inserted “, of such certification,” after “holder of such approved application”, and inserted “, the issuance of the certification,” after “approval of the approved application”.

Pub. L. 99–91section 357 of this titlesection 357 of this titlesection 357 of this titlesection 355 of this titleSubsec. (b). , §§ 2(2), 3(a)(3)(E)–(K), struck out “and if a United States Letter of Patent may not be issued for the drug” after “such a drug”, substituted “, if a certification is issued under for such a drug, or if a license” for “or a license”, inserted “, of the issuance of the certification under ,” after “application approval”, struck out “, if the drug is a biological product,” before “issue a license”, inserted “, issue another certification under ,” after “”, inserted “, of such certification,” after “holder of such approved application”, inserted “, of such certification,” after “application” in par. (1), and inserted “, issuance of other certifications,” after “other applications” in par. (2).

Pub. L. 98–4171984—Subsecs. (a), (b). substituted “section 355” for “section 355(b)” wherever appearing.

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Pub. L. 99–91section 8(b) of Pub. L. 99–91section 360aa of this titleAmendment by effective , see , set out as a note under .

Construction

Pub. L. 115–52, title VI, § 607(b)131 Stat. 1050

21 U.S.C. 360bb“Nothing in the amendments made by subsection (a) [amending this section] shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017 [].”
, , , provided that: