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: N022184

Product 001
BIMATOPROST (LUMIGAN) SOLUTION/DROPS 0.01%

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7851504 06/13/2027 DS DP
001 8278353 03/16/2025 DP
10/02/2012
001 8299118 03/16/2025
U-1295 A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION
11/16/2012
001 8309605 03/16/2025
U-1293 A METHOD OF LOWERING INTRAOCULAR PRESSURE IN A PATIENT WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
U-1294 METHOD OF TREATING GLAUCOMA IN A PATIENT
11/16/2012
001 8338479 03/16/2025 DP
U-1295 A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION
12/26/2012
001 8524777 03/16/2025
U-1235 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION
10/02/2013
001 8586630 03/16/2025
U-1458 A METHOD OF REDUCING INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
001 8772338 03/16/2025 DP
U-1528 A METHOD OF LOWERING INTRAOCULAR PRESSURE
07/21/2014
001 8933120 03/16/2025 DP
02/10/2015
001 8933127 03/16/2025 DP
02/10/2015
001 9155716 03/16/2025 DP
U-1528 A METHOD OF LOWERING INTRAOCULAR PRESSURE
11/12/2015
001 9241918 03/16/2025 DP
U-1814 METHOD OF TREATING GLAUCOMA OR ELEVATED INTRAOCULAR PRESSURE
02/24/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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