`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?
`U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=001&APPL_NO=210922&APPL_TYPE=N)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC
`EQUIVALENCE EVALUATIONS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=210922&APPL_TYPE=N)
`
`
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=210922&APPL_TYPE=N)
`
`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: N210922
`
`Product 001
`PATISIRAN SODIUM (ONPATTRO) SOLUTION EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`Submissio
`Date
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=210922&Appl_type=N
`
`1/3
`
`PROTIVA - EXHIBIT 2027
`Moderna Therapeutics, Inc. v. Protiva Biotherapeautics, Inc.
`IPR2018-00739
`
`
`
`10/30/2018
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`8058069 04/15/2029
`
`8158601 11/10/2030
`
`8168775 10/20/2029 DS
`
`8334373 05/27/2025 DS
`
`8362231 03/30/2021 DS
`
`8372968 03/30/2021 DS
`
`8492359 04/15/2029
`
`8552171 03/30/2021 DS
`
`8642076 10/03/2027
`
`8741866 10/20/2029
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`Patent
`Use
`Code
`
`U-2378
`
`U-2378
`
`U-2378
`
`Delist
`Requested
`
`Submissio
`Date
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`8778902 03/30/2021
`
`8802644 10/21/2030
`
`8822668 04/15/2029
`
`8895718 03/30/2021 DS
`
`8895721 03/30/2021 DS
`
`9193753 03/30/2021
`
`9234196 10/20/2029
`
`9364435 04/15/2029
`
`9567582 03/30/2021 DS
`
`9943538 11/04/2023
`
`9943539 11/04/2023
`
`U-2378
`
`U-2378
`
`U-2378
`
`U-2378
`
`U-2378
`
`U-2378
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`09/06/2018
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=210922&Appl_type=N
`
`2/3
`
`
`
`10/30/2018
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`NCE
`
`
`
`ODE-197
`
`
`
`08/10/2023
`
`08/10/2025
`
`
`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_No=210922&Appl_type=N
`
`3/3
`
`