Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N211172

Product 001
INOTERSEN SODIUM (TEGSEDI) SOLUTION EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7015315 03/21/2023 DS
11/01/2018
001 7101993 09/05/2023 DS
11/01/2018
001 8101743 04/01/2025 DS DP
11/01/2018
001 8697860 04/29/2031 DP
11/01/2018
001 9061044 04/29/2031 DS
11/01/2018
001 9399774 04/29/2031
U-2430 TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS
11/01/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
10/05/2023
001
ODE-212INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
COMPETITIVE GENERIC THERAPY
10/05/2025

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English