Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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 |
View a list of all patent use codes
View a list of all exclusivity codes
Last Updated April 16, 2021.
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