21 C.F.R. 314.3 - Definitions

Cite as21 C.F.R. 314.3
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199 practice notes
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...pharmaceutical ingredient'' in the proposal) to make it consistent with the definition of ``drug substance'' in current Sec. 314.3 (21 CFR 314.3). Current Sec. 207.3(a)(4) states, in part, that a ``bulk drug substance * * * becomes an active ingredient,'' but does not explain what it means ......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...pharmaceutical ingredient'' in the proposal) to make it consistent with the definition of ``drug substance'' in current Sec. 314.3 (21 CFR 314.3). Current Sec. 207.3(a)(4) states, in part, that a ``bulk drug substance * * * becomes an active ingredient,'' but does not explain what it means ......
  • Apotex, Inc. v. Daiichi Sankyo, Inc., Nos. 2014–1282
    • United States
    • United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
    • March 31, 2015
    ...that “could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug”); 21 C.F.R. §§ 314.3, 314.53. The first, U.S. Patent No. 5,616,599, covers the active ingredient of the drug, olmesartan medoxomil. It expires on April 25, 2016, bu......
  • United States v. Bader, No. 10–1263.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (10th Circuit)
    • May 3, 2012
    ...generally, but not necessarily, in association with one or more drug ingredients.’ ” Id. at 1154 n. 4 (emphases added) (quoting 21 C.F.R. 314.3(b)). These definitions—promulgated by the FDA itself—are certainly less than clear. At the very least, however, they provide a rudimentary foundati......
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136 cases
  • Apotex, Inc. v. Daiichi Sankyo, Inc., Nos. 2014–1282
    • United States
    • United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
    • March 31, 2015
    ...that “could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug”); 21 C.F.R. §§ 314.3, 314.53. The first, U.S. Patent No. 5,616,599, covers the active ingredient of the drug, olmesartan medoxomil. It expires on April 25, 2016, bu......
  • United States v. Bader, No. 10–1263.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (10th Circuit)
    • May 3, 2012
    ...generally, but not necessarily, in association with one or more drug ingredients.’ ” Id. at 1154 n. 4 (emphases added) (quoting 21 C.F.R. 314.3(b)). These definitions—promulgated by the FDA itself—are certainly less than clear. At the very least, however, they provide a rudimentary foundati......
  • Neurelis, Inc. v. Aquestive Therapeutics, Inc., D077984, D078186
    • United States
    • California Court of Appeals
    • November 17, 2021
    ...to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of drug action." (21 C.F.R. § 314.3 (2021).)3 Neurelis alleges that, at the time of the filing of Aquestive's Form S-1, Aquestive had not yet completed any clinical trials for L......
  • In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, Nos. 15-2875
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • August 9, 2017
    ...at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." 21 C.F.R. § 314.3 (2016).29 Eight days before Biovail filed its Petition, GSK employees sent an internal email expressing uncertainty as to whether Biovail had f......
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30 firm's commentaries
  • Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
    • United States
    • Mondaq United States
    • July 20, 2018
    ...Drug product patents include those "that claim the drug product . . . that is described in the pending or approved NDA." Id. (citing 21 C.F.R. § 314.3). FDA regulations define "drug product" as "a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, gene......
  • No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts
    • United States
    • LexBlog United States
    • May 17, 2017
    ...given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device ......
  • No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, And Shutts Down Utts
    • United States
    • Mondaq United States
    • May 17, 2017
    ...given the scope of the FDA's "changes being effected" exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the "CBE" regulation for drugs - note, there are similar CBE regulations for devices and biologics; we've discussed the device ......
  • Know the Rules! FDA’s New Regulations Change Responsibilities For ANDA Filers
    • United States
    • JD Supra United States
    • October 13, 2016
    ...be extended to the next business day. The amendments to the regulations now clarify both issues. In amending the Definition section of 21 C.F.R. § 314.3, FDA has stated that it will no longer issue “acceptance for filing letters” and instead will be issuing “paragraph IV acknowledgement let......
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2 books & journal articles
  • Initiating Litigation
    • United States
    • ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...applied to Hatch-Waxman patent suits, and dismissed the plaintiff for lack of standing. Id. at 399. 6. 35 U.S.C. § 271(e)(2)(A). 7. 21 C.F.R. §§ 314.3(b) & 314.50(a)(1) & 314.94(a)(1). 8. 21 C.F.R. § 314.50(a)(5). In In re Rosuvastatin Calcium Patent Litigation, the court held that ......
  • Too good to last? Will the FDA's proposed rule put an end to generic drug preemption under Mensing and Bartlett?
    • United States
    • Defense Counsel Journal Vol. 82 Nbr. 1, January - January 2015
    • January 1, 2015
    ...at 430. (44) Id. at 436 (emphases original). (45) Mensing, 131 S.Ct. at 2573. (46) Id. at 2574. (47) Id. (48) Id. at 2574, n. 2. (49) 21 C.F.R. 314.3. The application submitted by a generic drug under this statutory scheme is referred to as an abbreviated new drug application ("ANDA&qu......

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