New drug product exclusivity
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §314.108 |
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2 cases
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Watson Labs., Inc. v. Forest Labs. Inc.
...included a Paragraph IV certification--in which case it was permitted to be filed after four years. See 21 U.S.C. § 355(j)(5)(F)(ii); 21 C.F.R. § 314.108. 3. "JA" refers to the Joint Appendix. "Compl." and "Complaint" refer to the Third Consolidated and Amended Class Action Complaint locate......
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CVS Pharm. v. Forest Labs. (In re Watson Labs.)
...included a Paragraph IV certification--in which case it was permitted to be filed after four years. See 21 U.S.C. § 355(j)(5)(F)(ii); 21 C.F.R. § 314.108. [3] "JA" refers to the Appendix. "Compl." and "Complaint" refer to the Third Consolidated and Amended Class Action Complaint located at ......
2 firm's commentaries
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Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension
...that cause the drug to be an ester, salt ..․ responsible for the physiological or pharmacological action of the drug substance.” 21 C.F.R. § 314.108(a). (The FDA rule cited in Pfizer appears in Part 314, which relates to “Applications for FDA Approval to Market A New Drug.” In contrast, the......
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Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension
...that cause the drug to be an ester, salt ..․ responsible for the physiological or pharmacological action of the drug substance.” 21 C.F.R. § 314.108(a). (The FDA rule cited in Pfizer appears in Part 314, which relates to “Applications for FDA Approval to Market A New Drug.” In contrast, the......