21 C.F.R. 314.108 - New drug product exclusivity

Cite as21 C.F.R. 314.108
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34 cases
  • Otsuka Pharm. Co. v. Burwell, Civil Action No. 15–cv–1688 (KBJ)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 28, 2016
    ...FDA") is prohibited from approving applications for the marketing of certain other drugs. 21 U.S.C. § 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 c......
  • Kisor v. Wilkie, 18-15
    • United States
    • United States Supreme Court
    • June 26, 2019
    ...exclusive rights to drug products if they contain "no active moiety that has been approved by FDA in any other" new drug application. 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 bon......
  • Smithkline Beecham Corp. v. Apotex Corp., 98 C 3952.
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Northern District of Illinois)
    • March 3, 2003
    ...predecessor, the paroxetine patented by Ferrosan, but it was deemed new because the FDA had never approved the predecessor. See also 21 C.F.R. § 314.108. As required, the ANDA specified the process of manufacture that Apotex would use to make the product in commercial quantities, and the si......
  • T.H. v. Novartis Pharm. Corp., S233898
    • United States
    • United States State Supreme Court (California)
    • December 21, 2017
    ...a new chemical entity or an additional three years for a new use of a previously approved drug (see 21 U.S.C. § 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. (See Conte, supr......
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19 firm's commentaries
  • President Biden Signs Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition
    • United States
    • JD Supra United States
    • May 4, 2021
    ...1, 1–2 (May 19, 2015), https://www.fda.gov/media/92548/download. 2 21 U.S.C. §§ 355(j)(5)(F)(ii), 355(c)(3)(E)(ii) (2021). 3 Id. 4 21 C.F.R. § 314.108 (2021). 5 21 C.F.R. § 314.3(b). 6 The Ensuring Innovation Act, S. 415, 117th Cong. § 1(a)(1) (2021). 7 Amarin Pharm. Ir. Ltd. v. FDA, 106 F.......
  • Congress Takes Aim at Reducing the Cost of Medicine
    • United States
    • JD Supra United States
    • May 4, 2021
    ...over 20 years, interpreted the statute with the “active ingredient” language to require a new “active moiety” to receive exclusivity. 21 C.F.R. § 314.108 (1994). That said, drug companies have found at least some success in convincing courts that this interpretation was impermissible, see A......
  • Congress Takes Aim at Reducing the Cost of Medicine
    • United States
    • LexBlog United States
    • May 3, 2021
    ...over 20 years, interpreted the statute with the “active ingredient” language to require a new “active moiety” to receive exclusivity. 21 C.F.R. § 314.108 (1994). That said, drug companies have found at least some success in convincing courts that this interpretation was impermissible, see A......
  • Patent Term Extension for Drugs Not Limited to New Chemical Entities
    • United States
    • JD Supra United States
    • May 3, 2017
    ...PTE for an innovative use or dosage form of cromolyn sodium, which had previously approved by the FDA in inhalation capsule form). 6 21 C.F.R. § 314.108. 7 21 C.F.R. § 8 See PhotoCure Asa v. Kappos, 603 F.3d. 1372, 1375-76 (Fed. Cir. 2010) (holding that the drug product with the active ingr......
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5 books & journal articles
  • Taking the 'product' out of product liability: litigation risks and business implications of innovator and co-promoter liability.
    • United States
    • Defense Counsel Journal Vol. 82 Nbr. 3, July - July 2015
    • July 1, 2015
    ...from (though not necessarily in addition to) the patent term as a trade-off for generic drugs' easier entry into the market. See 21 C.F.R. 314.108 [section]; available att http://www.fda.gov/ drugs/develop mentapprovalprocess/ ucm079031.htm (last accessed May 19, 2015). (30) Weeks, 2014 WL ......
  • Regulatory and Enforcement Framework
    • United States
    • ABA Antitrust Library Pharmaceutical Industry Antitrust Handbook. Second Edition
    • December 8, 2018
    ...products with the same conditions of approval, for a period of three 119. 21 U.S.C. §§ 355(c)(3)(E)(ii) & (j)(5)(F)(ii). 120. Id. 121. 21 C.F.R. § 314.108. 122. Id. § 314.108(a). 123. Id. 124. Id. § 314.108(b)(2). 125. 21 U.S.C. §§ 355(c)(3)(E)(iii) & (j)(5)(F)(iii). 98 Pharmaceutical Indus......
  • Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials
    • United States
    • Iowa Law Review Nbr. 98-4, May 2013
    • May 1, 2013
    ...for the purposes of exclusivity is not whether the NCE is newly discovered but whether it has been previously approved for use. See 21 C.F.R. § 314.108(a). 371. See Jerome H. Reichman, Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Publ......
  • The Statutory and Regulatory Scheme
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...the District of Columbia district 38. Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265 (Fed. Cir. 2008). 39. 21 C.F.R. § 314.108. 40. 64 Fed. Reg. 47,719, 47,721 (Sept. 1, 1999). 41. See 21 C.F.R. § 314.108(a). 42. 54 Fed. Reg. 28,872, 28,898 (July 10, dor54588_01_ch01_......
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