Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Delisted Patents

About This List

The following is a list of patents that have been delisted since the most recent Annual Edition of the Orange Book.

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.

The following is a list of patents that have been delisted since the most recent Annual Edition of the Orange Book.

15 records returned
Appl No Active Ingredient Proprietary Name Dosage
Form
Route Strength Patent No. Patent Use Mkt. Status Submission Date
Appl No Active Ingredient Proprietary Name Dosage
Form
Route Strength Patent No. Patent Use Mkt. Status Submission Date
N021204 NATEGLINIDE STARLIX TABLET ORAL 60MG 6559188 U-827 RX
N021204 NATEGLINIDE STARLIX TABLET ORAL 120MG 6559188 U-827 RX
N021204 NATEGLINIDE STARLIX TABLET ORAL 60MG 6878749 RX
N021204 NATEGLINIDE STARLIX TABLET ORAL 120MG 6878749 RX
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7410978 DISCN
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7759359 U-1071 DISCN
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7763635 U-1071 DISCN
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7781448 U-1071 DISCN
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7781449 U-1071 DISCN
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 100MG ACID 8052995 U-1306 DISCN 12/11/2012
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 100MG ACID 8052995 U-1575 DISCN 12/11/2012
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 100MG ACID 8052995*PED DISCN
N205636 ALBUTEROL SULFATE PROAIR RESPICLICK POWDER, METERED INHALATION EQ 0.09MG BASE/INH 9782550 RX 01/09/2019
N205636 ALBUTEROL SULFATE PROAIR RESPICLICK POWDER, METERED INHALATION EQ 0.09MG BASE/INH 9782551 RX 01/09/2019
N210361 GLYCOPYRRONIUM TOSYLATE QBREXZA CLOTH TOPICAL EQ 2.4% BASE 9006462 RX 09/20/2018

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

Last Updated March 22, 2019.

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