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`Page 1 of 3
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`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
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`Home (index.cfm?resetfields=1) | Back to Product Details
`
`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: N021897
`
`Product 001
`NALTREXONE (VIVITROL) FOR SUSPENSION, EXTENDED RELEASE
`380MG/VIAL
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_...
`
`6/20/2018
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`Page 1 of 3
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`ALKERMES EXHIBIT 2014
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Page 2 of 3
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`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`6194006 12/30/2018
`
`6264987 05/19/2020
`
`6331317 11/12/2019
`
`6379703 12/30/2018
`
`6379704 05/19/2020
`
`6395304 11/12/2019
`
`6495164 05/25/2020
`
`6495166 11/12/2019
`
`6534092 05/19/2020
`
`6537586 11/12/2019
`
`6596316 12/30/2018
`
`6667061 05/25/2020
`
`6713090 11/12/2019
`
`6939033 11/12/2019
`
`7799345 05/25/2020
`
`7919499 10/15/2029
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`U-1123
`U-1124
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book
`database.
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_...
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`6/20/2018
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`Page 2 of 3
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`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 3 of 3
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`View a list of all patent use codes (results_patent.cfm)
`View a list of all exclusivity codes (results_exclusivity.cfm)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_...
`
`6/20/2018
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`Page 3 of 3
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