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.

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
N021903 IBUPROFEN LYSINE NEOPROFEN INJECTABLE INTRAVENOUS EQ 20MG BASE/2ML (EQ 10MG BASE/ML) 6344479
U-794 CLOSURE OF A CLINICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
RX
N021398 BRIMONIDINE TARTRATE; TIMOLOL MALEATE COMBIGAN SOLUTION/DROPS OPHTHALMIC 0.2%;EQ 0.5% BASE 7323463
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7776314
RX
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 7910605
U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 7910605
U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 7910605
U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 7910605
U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N021775 ALVIMOPAN ENTEREG CAPSULE ORAL 12MG 8112290
U-1443 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
RX 03/01/2012
N206488 ETEPLIRSEN EXONDYS 51 SOLUTION INTRAVENOUS 100MG/2ML (50MG/ML) 8486907
U-1904 (I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
RX 10/17/2016
N206488 ETEPLIRSEN EXONDYS 51 SOLUTION INTRAVENOUS 500MG/10ML (50MG/ML) 8486907
U-1904 (I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
RX 10/17/2016
N021775 ALVIMOPAN ENTEREG CAPSULE ORAL 12MG 8645160
U-1485 TREATING A SUBJECT UNDERGOING ABDOMINAL SURGERY BY ADMINISTERING ALVIMOPAN TO ACCELERATE THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
RX

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Last Updated April 16, 2021.

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