`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`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: N022387
`
`Product 001
`TREPROSTINIL (TYVASO) SOLUTION 0.6MG/ML
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`001
`
`8497393
`9339507
`
`12/15/2028
`03/10/2028
`
`DS
`
`DP
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`Submission
`Date
`
`Y
`
`08/20/2013
`05/17/2016
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022387&Appl_type=N
`
`1/2
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`IPR2021-00406
`United Therapeutics EX2007
`Page 1 of 2
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`
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`5/17/2021
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`001
`001
`001
`001
`
`
`
`05/05/2028
`9358240
`12/15/2028
`9593066
`12/15/2028
`9604901
`10376525 05/14/2027
`10716793 05/14/2027
`
`DS
`DS
`
`Patent
`Use
`Code
`U-1849
`
`U-1849
`U-1849
`
`Delist
`Requested
`
`Submission
`Date
`
`06/08/2016
`03/14/2017
`03/28/2017
`04/29/2020
`07/21/2020
`
`Exclusivity Data
`
`Product No
`001
`
`
`
`
`
`Exclusivity Code
`I-856
`
`
`Exclusivity Expiration
`03/31/2024
`
`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=022387&Appl_type=N
`
`2/2
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`IPR2021-00406
`United Therapeutics EX2007
`Page 2 of 2
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`