`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Drug Databases (https:/www.fda.gov/Drugs/InformationOnDrugs/)
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence
`
`Evaluations
`
`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: N210493
`
`Product 002
`FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON
`HYDROCHLORIDE (AKYNZEO) SOLUTION EQ 235MG BASE/20ML (EQ 11.75MG
`BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
`
`Patent Data
`
`Patent
`
`Product Patent Patent Drug Drug Use Delist Submission
`
`No No Expiration Substance Product Code Requested Date
`
`002 8426450 05/23/2032 DS DP 06/24/2020
`
`002 8895586 05/23/2032 U-2301 06/24/2020
`
`002 9186357 11/18/2030 U-2301 06/24/2020
`
`002 9403772 05/23/2032 DS U-2301 06/24/2020
`
`002 9908907 05/23/2032 DS DP 06/24/2020
`
`002 10208073 05/23/2032 U-2301 06/24/2020
`
`002 10624911 06/02/2037 DP 06/24/2020
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product. No=002&Appl_No=210493&Appl_type=N 1/2
`HELSINN EXHIBIT 2021
`
`Page 1 of 2
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`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`
`IPR2025-00945
`
`
`
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`
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`8/3/25, 3:47 PM
`
`Product
`No
`
`002
`002
`002
`002
`002
`
`Patent
`No
`
`10717721
`10828297
`11312698
`11529362
`12208109
`
`Exclusivity Data
`
`Product No
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Patent
`Expiration
`
`05/23/2032
`12/17/2030
`05/23/2032
`06/02/2037
`06/02/2037
`
`Drug Drug
`Substance Product
`
`DS
`
`DS DP
`DP
`DP
`
`Exclusivity Code
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`Exclusivity Expiration
`
`Your search did not return any results
`
`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=002&Appl_No=210493&Appl_type=N
`
`Page 2 of 2
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`Submission
`Date
`
`08/19/2020
`12/09/2020
`05/13/2022
`01/17/2023
`02/20/2025
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`2/2
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