Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home

Newly Added Patents

About This List
  • This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
  • This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
  • Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.
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.
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.01MG 10537581 11/21/2032 DP
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
RX 02/13/2020
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.01MG 10537581 11/21/2032 DP
U-2316 TREATMENT OF DYSPAREUNIA
RX 02/13/2020
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.004MG 10537581 11/21/2032 DP
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
RX 02/13/2020
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.004MG 10537581 11/21/2032 DP
U-2316 TREATMENT OF DYSPAREUNIA
RX 02/13/2020
N208573 VENETOCLAX VENCLEXTA TABLET ORAL 50MG 8722657 01/29/2032 DS
RX 02/13/2020
N208573 VENETOCLAX VENCLEXTA TABLET ORAL 100MG 8722657 01/29/2032 DS
RX 02/13/2020
N208573 VENETOCLAX VENCLEXTA TABLET ORAL 10MG 8722657 01/29/2032 DS
RX 02/13/2020

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

Last Updated February 18, 2020.

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