Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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.

Patent and Exclusivity for: N211911

Product 001
BIMATOPROST (DURYSTA) IMPLANT 10MCG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7799336 04/24/2029 DP
03/24/2020
001 8206737 04/07/2027
U-2759 REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN ANGLE GLAUCOMA(OAG) OR OCULAR HYPERTENSION (OHT) WITH A BIODEGRADABLE BIMATOPROST IMPLANT
03/24/2020
001 8629185 07/15/2031 DS DP
03/24/2020
001 8673341 02/19/2025
U-2759 REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN ANGLE GLAUCOMA(OAG) OR OCULAR HYPERTENSION (OHT) WITH A BIODEGRADABLE BIMATOPROST IMPLANT
03/24/2020
001 9149428 12/19/2026 DP
03/24/2020
001 9492316 10/31/2034 DP
03/24/2020
001 9980974 10/31/2034
U-2759 REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN ANGLE GLAUCOMA(OAG) OR OCULAR HYPERTENSION (OHT) WITH A BIODEGRADABLE BIMATOPROST IMPLANT
03/24/2020
001 10398707 04/30/2024
U-2759 REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN ANGLE GLAUCOMA(OAG) OR OCULAR HYPERTENSION (OHT) WITH A BIODEGRADABLE BIMATOPROST IMPLANT
03/24/2020
001 10441543 12/19/2026 DP
03/24/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
03/04/2023

 

 


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