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  • 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.
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Patent and Exclusivity for: N205437

Product 001
APREMILAST (OTEZLA) TABLET 10MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6962940 03/19/2023
U-1504 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
04/15/2014
001 7208516 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
04/15/2014
001 7427638 02/16/2028 DS DP
04/15/2014
001 7659302 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
04/15/2014
001 7893101 12/09/2023 DS DP
04/15/2014
001 8455536 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
04/15/2014
001 8802717 03/19/2023
U-1561 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
08/29/2014
001 9018243 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
05/18/2015
001 9724330 03/19/2023
U-1561 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
07/19/2018
001 9872854 05/29/2034
U-2232 TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE
U-2233 TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT
02/21/2018
001 10092541 05/29/2034
U-2403 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
U-2659 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE
10/09/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-803TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
COMPETITIVE GENERIC THERAPY
07/19/2022
001
M-257INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE USE OF PLAQUE PSORIASIS OF THE SCALP
COMPETITIVE GENERIC THERAPY
04/10/2023
001
ODE-248TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
COMPETITIVE GENERIC THERAPY
07/19/2026

 

 


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