C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 316—ORPHAN DRUGS › Subpart D—Orphan-drug Exclusive Approval

21 C.F.R. § 316.34

FDA recognition of exclusive approval

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely written notice recognizing exclusive approval once the marketing application for a designated orphan-drug product has been approved, if the same drug has not already been approved for the same use or indication. The written notice will inform the sponsor of the requirements for maintaining orphan-drug exclusive approval for the full 7-year term of exclusive approval.

(b) When a marketing application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for a designated orphan drug that qualifies for exclusive approval, FDA will publish in its publication entitled “Approved Drug Products With Therapeutic Equivalence Evaluations” information identifying the sponsor, the drug, and the date of termination of the orphan-drug exclusive approval. A subscription to this publication and its monthly cumulative supplements is available from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, and is also available online at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.

(c) If a drug is otherwise the same drug as a previously approved drug for the same use or indication, FDA will not recognize orphan-drug exclusive approval if the sponsor fails to demonstrate upon approval that the drug is clinically superior to the previously approved drug.

[78 FR 35135, June 12, 2013]
Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2020–2025 · leading case: Eagle Pharm., Inc. v. Alex Azar, II, 952 F.3d 323 (D.C. Cir. 2020).
Sort: Relevance Newest Treatment
Eagle Pharm., Inc. v. Alex Azar, II, 952 F.3d 323 (D.C. Cir. 2020). · cites it 2× “21 C.F.R. § 316.34 (c) (emphasis added). The FDA imposed this heightened post-approval clinical superiority requirement because, in its view, “sponsors could otherwise: (1) [o]btain infinite, successive 7-year periods of exclusivity for the same drug for the same use when the…”
Jazz Pharm., Inc. v. Robert F. Kennedy Jr., 141 F.4th 254 (D.C. Cir. 2025). · cites it 3× “21 C.F.R. § 316.34 (c). The “post- approval clinical-superiority requirement” is intended to prevent a sponsor from obtaining serial exclusivity periods— known as “evergreening”—or securing exclusivity without providing an additional or different benefit to patients over a…”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.