`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`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: N021743
`
`Product 001
`ERLOTINIB HYDROCHLORIDE (TARCEVA) TABLET EQ 25MG BASE
`
`Patent Data
`
`Product
`No
`
`Patent No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Patent Use Code
`
`Delist
`Requested
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=021743&Appl_type=N
`
`1/3
`
`APOTEX 1039-001
`
`
`
`7/12/2017
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Patent No
`
`Expiration Claim
`
`Claim
`
`Patent Use Code
`
`Requested
`
`No
`
`001
`
`001
`
`001
`
`5747498
`
`Nov 8,
`2018
`
`DS
`
`DP
`
`5747498*PED May 8,
`2019
`
`6900221
`
`Nov 9,
`2020
`
`DS
`
`DP
`
`U-659
`(show_code.cfm?
`id=786&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U-659
`(show_code.cfm?
`id=786&type=0)
`U-875
`(show_code.cfm?
`id=875&type=0)
`U-1046
`(show_code.cfm?
`id=1149&type=0)
`U-1403
`(show_code.cfm?
`id=1457&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U-659
`(show_code.cfm?
`id=786&type=0)
`U-1045
`(show_code.cfm?
`id=1148&type=0)
`U-1403
`(show_code.cfm?
`id=1457&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`001
`
`001
`
`6900221*PED May 9,
`2021
`
`7087613
`
`Nov 9,
`2020
`
`7087613*PED May 9,
`2021
`
`RE41065
`
`Nov 8,
`2018
`
`RE41065*PED May 8,
`2019
`
`001
`
`001
`
`001
`
`
`
`DS
`
`DP
`
`Exclusivity Data
`Patent
`Product
`Product No
`Exclusivity Code
`No
`Patent No
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Delist
`Exclusivity Expiration
`Patent Use Code
`Requested
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=021743&Appl_type=N
`
`2/3
`
`APOTEX 1039-002
`
`
`
`7/12/2017
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`001
`
`D-164 (show_code.cfm?id=164&type=1)
`
`May 20, 2019
`
`M-181 (show_code.cfm?id=1093&type=1)
`
`Jun 1, 2019
`
`M-190 (show_code.cfm?id=1102&type=1)
`
`Oct 18, 2019
`
`View a list of all patent use codes
`View a list of all exclusivity codes
`
`
` (results_patent.cfm)
` (results_exclusivity .cfm)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=021743&Appl_type=N
`
`3/3
`
`APOTEX 1039-003
`
`