.
`
`E. Department of Health and Human Services
`
`&
`EA UIS'
`ADMINISTRATION
`
`AtoElndEI:
`SEEI'Ch:d-1.
`
`FDIIDwFDA
`
`Eani-Dl
`
`Medical Devices
`
`Radiation—Emitting Products
`
`Vaccines. Blood & Biologics
`
`Animal aVeten'nary
`
`Cosmetics
`
`Tobacco Products
`
`Home > Dmg Databases > Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f SHARE
`
`5' TWEET
`
`in UNKEDIN
`
`FD PINI'I'
`
`fi EMAIL
`
`Q: PRINT
`
`| .FEEE.'E.I9..ETE9F!HEEEstelle
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314530205).
`
`- Patent listings published prior to August 13, 2003, only identify method—of—use claims. The listed patents may include drug substance andlor drug product
`claims that are not indicated in the listing.
`
`- As of December 5, 2015, an NBA 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.
`
`RE455?3*PED Dec 23, 2025
`
`Patent and Exclusivity for: N200603
`
`F'roduct 003
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET QUMG
`
`Patent Data
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`5532322
`
`Jul 2, 2018
`
`55323?2*PE
`
`Jan 2, 2019
`
`8729085
`
`8729085*PE
`
`8883294
`
`8883?94*PE
`
`9174925
`
`91749?5*PE
`
`9259423
`
`9259423*PE
`
`
`
`May 26, 2026
`
`Nov 26, 2025
`
`May 26, 2025
`
`Nov 26, 2025
`
`Jun 25, 2025
`
`Dec 25, 2026
`
`May 23, 2031
`
`NOV 23, 2031
`
`9555027Ir
`
`May 26, 2025
`
`RE455?3
`
`Jun 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 001
`
`
`
`E. Department of Health and Human Services
`
`&
`EA UIS'
`ADMINISTRATION
`
`AtoElndEI:
`SEEI'Ch:d-1.
`
`FDIIDwFDA
`
`Eani-Dl
`
`Medical Devices
`
`Radiation—Emitting Products
`
`Vaccines. Blood & Biologics
`
`Animal aVeten'nary
`
`Cosmetics
`
`Tobacco Products
`
`Home > Dmg Databases > Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f SHARE
`
`5' TWEET
`
`in UNKEDIN
`
`FD PINI'I'
`
`fi EMAIL
`
`Q: PRINT
`
`| .FEEE.'E.I9..ETE9F!HEEEstelle
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314530205).
`
`- Patent listings published prior to August 13, 2003, only identify method—of—use claims. The listed patents may include drug substance andlor drug product
`claims that are not indicated in the listing.
`
`- As of December 5, 2015, an NBA 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.
`
`RE455?3*PED Dec 23, 2025
`
`Patent and Exclusivity for: N200603
`
`F'roduct 003
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET QUMG
`
`Patent Data
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`5532322
`
`Jul 2, 2018
`
`55323?2*PE
`
`Jan 2, 2019
`
`8729085
`
`8729085*PE
`
`8883294
`
`8883?94*PE
`
`9174925
`
`91749?5*PE
`
`9259423
`
`9259423*PE
`
`
`
`May 26, 2026
`
`Nov 26, 2025
`
`May 26, 2025
`
`Nov 26, 2025
`
`Jun 25, 2025
`
`Dec 25, 2026
`
`May 23, 2031
`
`NOV 23, 2031
`
`9555027Ir
`
`May 26, 2025
`
`RE455?3
`
`Jun 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 001
`
`
`
`Exclusivity Data
`
`Product No
`
`Exclusiu'ityr Code
`
`Exclusivity Expiration
`
`003
`
`003
`
`003
`
`003
`
`
`
`NPR
`
`Egg
`
`PEIIJI
`
`Jan 2?, 2020
`
`Jan 2?, 2020
`
`Jul 27, 2020
`
`Jul 2?, 2020
`
`Elegy a list of all patent use codes
`flew a list of all exclusivity codes
`
`25% |,_._—-Ja'|
`
`
`
`
`
`
`Note: It you need help accessing infonnation in different file formats, see lnshuclions for Downloading Viewers and Players.
`Language Assistance Available: Espafiol lfi-fiaEFIEZ |Tiéng Viét | Ell-P101 |Tagalog | Pyccicnfil | 3-sin | Kreon Ayisyen | Francaisl Polski | Portugues | Italiano | Deulsch |
`English
`
`Website Policies
`
`bilii‘y'
`
`Careers
`
`FDA Basics
`
`FOIA
`
`No FEAR Act
`
`Site Map
`
`Nor:-:tis:::rin'lin ation
`
`U. 5. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring. MD 20993
`1-838—lNFO-FDA (1 -838-463-6332}
`
`Contact FDA
`
`one
`
`Q FDA Archiye
`
`A Emergency Preparedness
`
`Pl Federal. State & Local Officials
`
`i- Combination Products
`
`0 lntemational Programs
`
`5 Consumers
`
`E Advisory Committees
`
`G. Regulatory Information
`
`a; News 8; Events
`
`Health Professionals
`
`5' Training 8. Continuing Education
`
`A Science 8. Research
`
`0 Safetyr
`
`0 Inspections El Compliance
`
`{l- Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 002
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 002
`
`
`
`.
`
`E. Department of Health and Human Services
`
`&
`EA UIS'
`ADMINISTRATION
`
`AtoElndEI:
`SEEI'Ch:d-1.
`
`FDIIDwFDA
`
`Eani-Dl
`
`Medical Devices
`
`Radiation—Emitting Products
`
`Vaccines. Blood & Biologics
`
`Animal aVeten'nary
`
`Cosmetics
`
`Tobacco Products
`
`Home > Dmg Databases > Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f SHARE
`
`5' TWEET
`
`in UNKEDIN
`
`FD PINI'I'
`
`fi EMAIL
`
`Q: PRINT
`
`| .FEEE.'E.I9..ETE9F!HEEEstelle
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314530205).
`
`- Patent listings published prior to August 13, 2003, only identify method—of—use claims. The listed patents may include drug substance andlor drug product
`claims that are not indicated in the listing.
`
`- As of December 5, 2015, an NBA 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.
`
`RE455?3*PED Dec 23, 2025
`
`Patent and Exclusivity for: N200603
`
`F'roduct 001
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 40MG
`
`Patent Data
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`5532322
`
`Jul 2, 2018
`
`55323?2*PE
`
`Jan 2, 2019
`
`8729085
`
`8729085*PE
`
`8883294
`
`8883?94*PE
`
`9174925
`
`91749?5*PE
`
`9259423
`
`9259423*PE
`
`
`
`May 26, 2026
`
`Nov 26, 2025
`
`May 26, 2025
`
`Nov 26, 2025
`
`Jun 25, 2025
`
`Dec 25, 2026
`
`May 23, 2031
`
`NOV 23, 2031
`
`9555027Ir
`
`May 26, 2025
`
`RE455?3
`
`Jun 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 003
`
`
`
`Exclusivity Data
`
`Product No
`
`Exclusiu'ityr Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`001
`
`001
`
`
`
`NPR
`
`Egg
`
`PEIIJI
`
`Jan 2?, 2020
`
`Jan 2?, 2020
`
`Jul 27, 2020
`
`Jul 2?, 2020
`
`Elegy a list of all patent use codes
`flew a list of all exclusivity codes
`
`25% |,_._—-Ja'|
`
`
`
`
`
`
`Note: It you need help accessing infonnation in different file formats, see lnshuclions for Downloading Viewers and Players.
`Language Assistance Available: Espafiol lfi-fiaEFIEZ |Tiéng Viét | Ell-P101 |Tagalog | Pyccicnfil | 3-sin | Kreon Ayisyen | Francaisl Polski | Portugues | Italiano | Deulsch |
`English
`
`Website Policies
`
`bilii‘y'
`
`Careers
`
`FDA Basics
`
`FOIA
`
`No FEAR Act
`
`Site Map
`
`Nor:-:tis:::rin'lin ation
`
`U. 5. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring. MD 20993
`1-838—lNFO-FDA (1 -838-463-6332}
`
`Contact FDA
`
`one
`
`Q FDA Archiye
`
`A Emergency Preparedness
`
`Pl Federal. State & Local Officials
`
`i- Combination Products
`
`0 lntemational Programs
`
`5 Consumers
`
`E Advisory Committees
`
`G. Regulatory Information
`
`a; News 8; Events
`
`Health Professionals
`
`5' Training 8. Continuing Education
`
`A Science 8. Research
`
`0 Safetyr
`
`0 Inspections El Compliance
`
`{l- Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 004
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 004
`
`
`
`.
`
`E. Department of Health and Human Services
`
`&
`EA UIS'
`ADMINISTRATION
`
`AtoElndEI:
`SEEI'Ch:d-1.
`
`FDIIDwFDA
`
`Eani-Dl
`
`Medical Devices
`
`Radiation—Emitting Products
`
`Vaccines. Blood & Biologics
`
`Animal aVeten'nary
`
`Cosmetics
`
`Tobacco Products
`
`Home > Dmg Databases > Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f SHARE
`
`5' TWEET
`
`in UNKEDIN
`
`FD PINI'I'
`
`fi EMAIL
`
`Q: PRINT
`
`| .FEEE.'E.I9..ETE9F!HEEEstelle
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314530205).
`
`- Patent listings published prior to August 13, 2003, only identify method—of—use claims. The listed patents may include drug substance andlor drug product
`claims that are not indicated in the listing.
`
`- As of December 5, 2015, an NBA 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.
`
`RE455?3*PED Dec 23, 2025
`
`Patent and Exclusivity for: N200603
`
`F'roduct 005
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET BUMG
`
`Patent Data
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`5532322
`
`Jul 2, 2018
`
`55323?2*PE
`
`Jan 2, 2019
`
`8729085
`
`8729085*PE
`
`8883294
`
`8883?94*PE
`
`9174925
`
`91749?5*PE
`
`9259423
`
`9259423*PE
`
`
`
`May 26, 2026
`
`Nov 26, 2025
`
`May 26, 2025
`
`Nov 26, 2025
`
`Jun 25, 2025
`
`Dec 25, 2026
`
`May 23, 2031
`
`NOV 23, 2031
`
`9555027Ir
`
`May 26, 2025
`
`RE455?3
`
`Jun 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 005
`
`
`
`Exclusivity Data
`
`Product No
`
`Exclusiu'ityr Code
`
`Exclusivity Expiration
`
`005
`
`005
`
`005
`
`005
`
`
`
`NPR
`
`Egg
`
`PEIIJI
`
`Jan 2?, 2020
`
`Jan 2?, 2020
`
`Jul 27, 2020
`
`Jul 2?, 2020
`
`Elegy a list of all patent use codes
`flew a list of all exclusivity codes
`
`25% |,_._—-Ja'|
`
`
`
`
`
`
`Note: It you need help accessing infonnation in different file formats, see lnshuclions for Downloading Viewers and Players.
`Language Assistance Available: Espafiol lfi-fiaEFIEZ |Tiéng Viét | Ell-P101 |Tagalog | Pyccicnfil | 3-sin | Kreon Ayisyen | Francaisl Polski | Portugues | Italiano | Deulsch |
`English
`
`Website Policies
`
`bilii‘y'
`
`Careers
`
`FDA Basics
`
`FOIA
`
`No FEAR Act
`
`Site Map
`
`Nor:-:tis:::rin'lin ation
`
`U. 5. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring. MD 20993
`1-838—lNFO-FDA (1 -838-463-6332}
`
`Contact FDA
`
`one
`
`Q FDA Archiye
`
`A Emergency Preparedness
`
`Pl Federal. State & Local Officials
`
`i- Combination Products
`
`0 lntemational Programs
`
`5 Consumers
`
`E Advisory Committees
`
`G. Regulatory Information
`
`a; News 8; Events
`
`Health Professionals
`
`5' Training 8. Continuing Education
`
`A Science 8. Research
`
`0 Safetyr
`
`0 Inspections El Compliance
`
`{l- Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 006
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 006
`
`
`
`.
`
`E. Department of Health and Human Services
`
`&
`EA UIS'
`ADMINISTRATION
`
`AtoElndEI:
`SEEI'Ch:d-1.
`
`FDIIDwFDA
`
`Eani-Dl
`
`Medical Devices
`
`Radiation—Emitting Products
`
`Vaccines. Blood & Biologics
`
`Animal aVeten'nary
`
`Cosmetics
`
`Tobacco Products
`
`Home > Dmg Databases > Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f SHARE
`
`5' TWEET
`
`in UNKEDIN
`
`FD PINI'I'
`
`fi EMAIL
`
`Q: PRINT
`
`| .FEEE.'E.I9..ETE9F!HEEEstelle
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314530205).
`
`- Patent listings published prior to August 13, 2003, only identify method—of—use claims. The listed patents may include drug substance andlor drug product
`claims that are not indicated in the listing.
`
`- As of December 5, 2015, an NBA 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.
`
`RE455?3*PED Dec 23, 2025
`
`Patent and Exclusivity for: N200603
`
`F'roduct 002
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET BUMG
`
`Patent Data
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`5532322
`
`Jul 2, 2018
`
`55323?2*PE
`
`Jan 2, 2019
`
`8729085
`
`8729085*PE
`
`8883294
`
`8883?94*PE
`
`9174925
`
`91749?5*PE
`
`9259423
`
`9259423*PE
`
`
`
`May 26, 2026
`
`Nov 26, 2025
`
`May 26, 2025
`
`Nov 26, 2025
`
`Jun 25, 2025
`
`Dec 25, 2026
`
`May 23, 2031
`
`NOV 23, 2031
`
`9555027Ir
`
`May 26, 2025
`
`RE455?3
`
`Jun 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 007
`
`
`
`Exclusivity Data
`
`Product No
`
`Exclusiv'ityr Code
`
`Exclusivity Expiration
`
`ooz
`
`002
`
`__NPP__
`
`PED
`
`Jan 2?, 2020
`
`Jul 2?, 2020
`
`
`
`
`
`' w a list ofall patent use co
`1_.v a list of all exclusivity co
`
`
`
`Note: It you need help accessing infonnation in different file formats, see lnstmctions for Downloading Viewers and Players.
`
`Language Assistance Available: Espafiol Ifi-Eamfl ITiéng Viét | cit-.7401 |Tagalog | Pyccicnfi | laws" I Kreon Ayisyen | Francaisl Polski | Portugués | Italiano | Deutsch | -253? ILr-JJ'I
`English
`
`Website Policies
`
`'ibility
`
`Careers
`
`FDA Basics
`
`FOIA
`
`No FEAR Act
`
`Site Map
`
`Nc:rrdi5n::rimin ation
`
`U. 5. Food and Drug Adminislmtion
`10903 New Hampshire Avenue
`Silver Spring. MD 20993
`1-888—INFO-FDA(1338-4133-5332)
`
`Contact FDA
`
`Elia
`
`Q FDA Archive
`
`A Emergency Preparedness
`
`Pl Federal. State a Local Officials
`
`B- Combination Products
`
`9 International Programs
`
`5 Consumers
`
`fl Advisory Committees
`
`Q Regulatory Information
`
`E; News 8; Events
`
`Health Professionals
`
`8' Training 8. Continuing Education
`
`A Science 8. Research
`
`0 Safety
`
`0 Inspections & Compliance
`
`{1- Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 008
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 008
`
`
`
`.
`
`E. Department of Health and Human Services
`
`&
`EA UIS'
`ADMINISTRATION
`
`AtoElndEI:
`SEEI'Ch:d-1.
`
`FDIIDwFDA
`
`Eani-Dl
`
`Medical Devices
`
`Radiation—Emitting Products
`
`Vaccines. Blood & Biologics
`
`Animal aVeten'nary
`
`Cosmetics
`
`Tobacco Products
`
`Home > Dmg Databases > Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f SHARE
`
`5' TWEET
`
`in UNKEDIN
`
`FD PINI'I'
`
`fi EMAIL
`
`Q: PRINT
`
`| .FEEE.'E.I9..ETE9F!HEEEstelle
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314530205).
`
`- Patent listings published prior to August 13, 2003, only identify method—of—use claims. The listed patents may include drug substance andlor drug product
`claims that are not indicated in the listing.
`
`- As of December 5, 2015, an NBA 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.
`
`RE455?3*PED Dec 23, 2025
`
`Patent and Exclusivity for: N200603
`
`F'roduct 004
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 120MG
`
`Patent Data
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`5532322
`
`Jul 2, 2018
`
`55323?2*PE
`
`Jan 2, 2019
`
`8729085
`
`8729085*PE
`
`8883294
`
`8883?94*PE
`
`9174925
`
`91749?5*PE
`
`9259423
`
`9259423*PE
`
`
`
`May 26, 2026
`
`Nov 26, 2025
`
`May 26, 2025
`
`Nov 26, 2025
`
`Jun 25, 2025
`
`Dec 25, 2026
`
`May 23, 2031
`
`NOV 23, 2031
`
`9555027Ir
`
`May 26, 2025
`
`RE455?3
`
`Jun 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 009
`
`
`
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