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: N209637

Product 001
SEMAGLUTIDE (OZEMPIC) SOLUTION 2MG/1.5ML (1.34MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6899699 01/02/2022 DP
12/20/2017
001 7762994 05/23/2024 DP
12/20/2017
001 8114833 08/13/2025 DP
12/20/2017
001 8129343 01/29/2029 DS DP
U-2202 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
12/20/2017
001 8536122 03/20/2026 DS DP
U-2202 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
12/20/2017
001 8579869 06/30/2023 DP
12/20/2017
001 8672898 01/02/2022 DP
12/20/2017
001 8684969 10/20/2025 DP
12/20/2017
001 8920383 07/17/2026 DP
12/20/2017
001 9108002 01/20/2026 DP
12/20/2017
001 9132239 02/01/2032 DP
12/20/2017
001 9457154 09/27/2027 DP
12/20/2017
001 9486588 01/02/2022 DP
12/20/2017
001 9616180 01/20/2026 DP
08/17/2018
001 9687611 02/27/2027 DP
12/20/2017
001 9775953 07/17/2026 DP
12/20/2017
001 9861757 01/20/2026 DP
08/17/2018
001 10220155 07/17/2026 DP
04/04/2019
001 10335462 06/21/2033
U-2580 A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF
07/25/2019
001 10357616 01/20/2026 DP
08/08/2019
001 10376652 01/20/2026 DP
09/13/2019
001 RE46363 08/03/2026 DP
12/20/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
12/05/2022
001
I-822REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION OR NON-FATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
COMPETITIVE GENERIC THERAPY
01/16/2023

 

 


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