-5. Department of Health and Human Services
`
`NY U.S. FOOD & DRUG
`ADMINISTRATION
`
`Fe isedleg | Follow FDA, =esale
`
`Search FDA
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`
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`Home Food Drugs Medical Devices Animal & Veterinary|Cosmetics|Tobacco ProductsRadiation-Emitting Products|Vaccines, Blood & Biologics
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`Home » Drug Databases » Orange Book Home
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`Evaluations
`
`f sHaRe|WeTWEET|in UNKEOIN @ PINT|Hema & PRINT
`
`Home| BacktoProductDetails
`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. Thelisted 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 patentthat claims both the drug substance and the drug product(andiseligible 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 Bookpatentlisting, regardless of whenfirst published, to determine the range of patent claims that may be asserted by an NDA holderor patent
`owner.
`
`Patent and Exclusivity for: N200603
`
`Product 003.
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 20MG
`
`Patent Data
`
`
`
`Product
`No
`
`Patent No
`
`Patent
`Sedeeel]
`
`Tatelect
`Claim
`
`Drug Product
`Claim
`
`teeta ty
`Code
`
`reteg
`Requested
`
`oo3
`
`003
`
`oo3
`
`003
`
`oo3
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`oo3
`
`5332372
`
`Jul 2, 2018
`
`DS
`
`5532372*PED Jan 2, 2019
`
`
`
`8729085
`
`May 26, 2026
`
`8729085*PED Nov 26, 2026
`
`8883794
`
`May 26, 2026
`
`8883794*PED Nov 26, 2026
`
`9174975
`
`Jun 25, 2026
`
`9174975*PED Dec 25, 20276
`
`9259423
`
`May 23, 2031
`
`9259423*PED Nov 23, 2031
`
`9555027
`
`RE45573
`
`May 26, 2026
`
`Jun 23, 2025
`
`DS
`
`RE45573*PED Dec 23, 2025
`
`DP
`
`DP
`
`U-1770
`
`U-1822
`
`DP
`
`U-543
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 001
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 001
`
`

`

`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`003
`
`003
`
`003
`
`003
`
`
`
`NPP
`
`PED
`
`PED
`
`Jan 27, 2020
`
`Jan 27, 2020
`
`Jul 27, 2020
`
`Jul 27, 2020
`
`Viewalist of all patent use codes
`View a list of all exclusivity codes
`
`Note: If you need help accessing informationin different file formats, see Instructions for Downloading Viewers and Players.
`Lanquage Assistance Available: Espajiol | 288832 | Tiéng Viét | S+=0] | Tagalog | Pyccruii | 42)| Kreydl Ayisyen| Francais | Polski | Portugués| Italiano | Deutsch |
`English
`
`
`
`
`
`
`RaS3B | J |
`
`Website Policies
`
`ie)ray
`
`No FEAR Act
`
`Site Map
`
`iCaletaTessaalareLite)
`
`bility
`
`Lees|t-t=b}
`
`FDA Basics
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA (1-888-463-6332)
`
`Contact FDA
`one8o
`
`[tuba}
`
`D
`
`Q FDA Archive
`
`A Emergency Preparedness
`
`™ Federal, State & Local Officials
`
`#* Combination Products
`
`@ International Programs
`
`& Consumers
`
`Advisory Committees
`o_o
`
`Regulatory Information
`
`@ Safety
`
`ES News & Events
`ous
`
`@ Training & Continuing Education
`
`© Inspections & Compliance
`
`Health Professionals
`
`A Science & Research
`
`Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 002
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 002
`
`

`

`-5. Department of Health and Human Services
`
`NY U.S. FOOD & DRUG
`ADMINISTRATION
`
`Fe isedleg | Follow FDA, =esale
`
`Search FDA
`
`
`
`
`
`
`
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`
`Home Food Drugs Medical Devices Animal & Veterinary|Cosmetics|Tobacco ProductsRadiation-Emitting Products|Vaccines, Blood & Biologics
`
`
`
`Home » Drug Databases » Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f sHaRe|WeTWEET|in UNKEOIN @ PINT|Hema & PRINT
`
`Home| BacktoProductDetails
`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. Thelisted 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 patentthat claims both the drug substance and the drug product(andiseligible 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 Bookpatentlisting, regardless of whenfirst published, to determine the range of patent claims that may be asserted by an NDA holderor patent
`owner.
`
`Patent and Exclusivity for: N200603
`
`Product 001
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 40MG
`
`Patent Data
`
`
`
`Product
`No
`
`Patent No
`
`Patent
`Sedeeel]
`
`Tatelect
`Claim
`
`Drug Product
`Claim
`
`teeta ty
`Code
`
`reteg
`Requested
`
`ool
`
`ool
`
`ool
`
`oo1
`
`oo1
`
`oo1
`
`oo1
`
`oo1l
`
`oo1
`
`ool
`
`oo1
`
`ool
`
`ool
`
`5332372
`
`Jul 2, 2018
`
`DS
`
`5532372*PED Jan 2, 2019
`
`
`
`8729085
`
`May 26, 2026
`
`8729085*PED Nov 26, 2026
`
`8883794
`
`May 26, 2026
`
`8883794*PED Nov 26, 2026
`
`9174975
`
`Jun 25, 2026
`
`9174975*PED Dec 25, 20276
`
`9259423
`
`May 23, 2031
`
`9259423*PED Nov 23, 2031
`
`9555027
`
`RE45573
`
`May 26, 2026
`
`Jun 23, 2025
`
`DS
`
`RE45573*PED Dec 23, 2025
`
`DP
`
`DP
`
`U-1770
`
`U-1822
`
`DP
`
`U-543
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 003
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 003
`
`

`

`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`oo1
`
`oo1
`
`001
`
`oOo1
`
`
`
`NPP
`
`PED
`
`PED
`
`Jan 27, 2020
`
`Jan 27, 2020
`
`Jul 27, 2020
`
`Jul 27, 2020
`
`Viewalist of all patent use codes
`View a list of all exclusivity codes
`
`Note: If you need help accessing informationin different file formats, see Instructions for Downloading Viewers and Players.
`Lanquage Assistance Available: Espajiol | 288832 | Tiéng Viét | S+=0] | Tagalog | Pyccruii | 42)| Kreydl Ayisyen| Francais | Polski | Portugués| Italiano | Deutsch |
`English
`
`
`
`
`
`
`RaS3B | J |
`
`Website Policies
`
`ie)ray
`
`No FEAR Act
`
`Site Map
`
`iCaletaTessaalareLite)
`
`bility
`
`Lees|t-t=b}
`
`FDA Basics
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA (1-888-463-6332)
`
`Contact FDA
`one8o
`
`[tuba}
`
`D
`
`Q FDA Archive
`
`A Emergency Preparedness
`
`™ Federal, State & Local Officials
`
`#* Combination Products
`
`@ International Programs
`
`& Consumers
`
`Advisory Committees
`o_o
`
`Regulatory Information
`
`@ Safety
`
`ES News & Events
`ous
`
`@ Training & Continuing Education
`
`© Inspections & Compliance
`
`Health Professionals
`
`A Science & Research
`
`Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 004
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 004
`
`

`

`-5. Department of Health and Human Services
`
`NY U.S. FOOD & DRUG
`ADMINISTRATION
`
`Fe isedleg | Follow FDA, =esale
`
`Search FDA
`
`
`
`
`
`
`
`
`
`Home Food Drugs Medical Devices Animal & Veterinary|Cosmetics|Tobacco ProductsRadiation-Emitting Products|Vaccines, Blood & Biologics
`
`
`
`Home » Drug Databases » Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f sHaRe|WeTWEET|in UNKEOIN @ PINT|Hema & PRINT
`
`Home| BacktoProductDetails
`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. Thelisted 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 patentthat claims both the drug substance and the drug product(andiseligible 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 Bookpatentlisting, regardless of whenfirst published, to determine the range of patent claims that may be asserted by an NDA holderor patent
`owner.
`
`Patent and Exclusivity for: N200603
`
`Product 005
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 60MG
`
`Patent Data
`
`
`
`Product
`No
`
`Patent No
`
`Patent
`Sedeeel]
`
`Tatelect
`Claim
`
`Drug Product
`Claim
`
`teeta ty
`Code
`
`reteg
`Requested
`
`oo5
`
`005
`
`oo5
`
`oo5
`
`005
`
`oo5
`
`005
`
`oo5
`
`005
`
`005
`
`005
`
`005
`
`oo5
`
`5332372
`
`Jul 2, 2018
`
`DS
`
`5532372*PED Jan 2, 2019
`
`
`
`8729085
`
`May 26, 2026
`
`8729085*PED Nov 26, 2026
`
`8883794
`
`May 26, 2026
`
`8883794*PED Nov 26, 2026
`
`9174975
`
`Jun 25, 2026
`
`9174975*PED Dec 25, 20276
`
`9259423
`
`May 23, 2031
`
`9259423*PED Nov 23, 2031
`
`9555027
`
`RE45573
`
`May 26, 2026
`
`Jun 23, 2025
`
`DS
`
`RE45573*PED Dec 23, 2025
`
`DP
`
`DP
`
`U-1770
`
`U-1822
`
`DP
`
`U-543
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 005
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 005
`
`

`

`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`oo5
`
`005
`
`00s
`
`005
`
`
`
`NPP
`
`PED
`
`PED
`
`Jan 27, 2020
`
`Jan 27, 2020
`
`Jul 27, 2020
`
`Jul 27, 2020
`
`Viewalist of all patent use codes
`View a list of all exclusivity codes
`
`Note: If you need help accessing informationin different file formats, see Instructions for Downloading Viewers and Players.
`Lanquage Assistance Available: Espajiol | 288832 | Tiéng Viét | S+=0] | Tagalog | Pyccruii | 42)| Kreydl Ayisyen| Francais | Polski | Portugués| Italiano | Deutsch |
`English
`
`
`
`
`
`
`RaS3B | J |
`
`Website Policies
`
`ie)ray
`
`No FEAR Act
`
`Site Map
`
`iCaletaTessaalareLite)
`
`bility
`
`Lees|t-t=b}
`
`FDA Basics
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA (1-888-463-6332)
`
`Contact FDA
`one8o
`
`[tuba}
`
`D
`
`Q FDA Archive
`
`A Emergency Preparedness
`
`™ Federal, State & Local Officials
`
`#* Combination Products
`
`@ International Programs
`
`& Consumers
`
`Advisory Committees
`o_o
`
`Regulatory Information
`
`@ Safety
`
`ES News & Events
`ous
`
`@ Training & Continuing Education
`
`© Inspections & Compliance
`
`Health Professionals
`
`A Science & Research
`
`Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 006
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 006
`
`

`

`-5. Department of Health and Human Services
`
`NY U.S. FOOD & DRUG
`ADMINISTRATION
`
`Fe isedleg | Follow FDA, =esale
`
`Search FDA
`
`
`
`
`
`
`
`
`
`Home Food Drugs Medical Devices Animal & Veterinary|Cosmetics|Tobacco ProductsRadiation-Emitting Products|Vaccines, Blood & Biologics
`
`
`
`Home » Drug Databases » Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f sHaRe|WeTWEET|in UNKEOIN @ PINT|Hema & PRINT
`
`Home| BacktoProductDetails
`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. Thelisted 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 patentthat claims both the drug substance and the drug product(andiseligible 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 Bookpatentlisting, regardless of whenfirst published, to determine the range of patent claims that may be asserted by an NDA holderor patent
`owner.
`
`Patent and Exclusivity for: N200603
`
`Product 002
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 80MG
`
`Patent Data
`
`
`
`Product
`No
`
`Patent No
`
`Patent
`Sedeeel]
`
`Tatelect
`Claim
`
`Drug Product
`Claim
`
`teeta ty
`Code
`
`reteg
`Requested
`
`oo2
`
`002
`
`oo2
`
`002
`
`oo2
`
`002
`
`002
`
`002
`
`002
`
`002
`
`a02
`
`002
`
`oo2
`
`5332372
`
`Jul 2, 2018
`
`DS
`
`5532372*PED Jan 2, 2019
`
`
`
`8729085
`
`May 26, 2026
`
`8729085*PED Nov 26, 2026
`
`8883794
`
`May 26, 2026
`
`8883794*PED Nov 26, 2026
`
`9174975
`
`Jun 25, 2026
`
`9174975*PED Dec 25, 20276
`
`9259423
`
`May 23, 2031
`
`9259423*PED Nov 23, 2031
`
`9555027
`
`RE45573
`
`May 26, 2026
`
`Jun 23, 2025
`
`DS
`
`RE45573*PED Dec 23, 2025
`
`DP
`
`DP
`
`U-1770
`
`U-1822
`
`DP
`
`U-543
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 007
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 007
`
`

`

`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`002
`
`a02
`
`NPP
`
`PED
`
`Jan 27, 2020
`
`Jul 27, 2020
`
`
`
`
`Ww a list of all exclusivity co
`lew a list of all patent use co
`
`
`
`
`Note: lf you need help accessing informationin different file formats, see Instructions for Downloading Viewers and Players.
`
`
`
`Language Assistance Available: Espafiol | $8823 | Tiéng Viét | S+=0] | Tagalog | Pycckwii | 4.=! | Kreydl Ayisyen | Francais | Polski | Portugués| Italiano | Deutsch | Bas38 ||
`English
`
`Website Policies
`
`FOLA
`
`No FEAR Act
`
`Beye)
`
`Ta)geasmSLD
`
`taya
`
`Oe-=b9
`
`FDA Basics
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA (1-888-463-6332)
`
`Contact FDA
`
`fau
`08 @
`
`Q FDA Archive
`
`A Emergency Preparedness.
`
`j™ Federal, State & Local Officials
`
`B= Combination Products
`
`@ International Programs
`
`& Consumers
`
`Advisory Committees
`
`fi News & Events
`
`Health Professionals
`
`#, Regulatory Information
`
`@ Training & Continuing Education
`
`A Science & Research
`
`@ Safety
`
`@ Inspections & Compliance
`
`# Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 008
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 008
`
`

`

`-5. Department of Health and Human Services
`
`NY U.S. FOOD & DRUG
`ADMINISTRATION
`
`Fe isedleg | Follow FDA, =esale
`
`Search FDA
`
`
`
`
`
`
`
`
`
`Home Food Drugs Medical Devices Animal & Veterinary|Cosmetics|Tobacco ProductsRadiation-Emitting Products|Vaccines, Blood & Biologics
`
`
`
`Home » Drug Databases » Orange Book Home
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`
`f sHaRe|WeTWEET|in UNKEOIN @ PINT|Hema & PRINT
`
`Home| BacktoProductDetails
`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. Thelisted 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 patentthat claims both the drug substance and the drug product(andiseligible 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 Bookpatentlisting, regardless of whenfirst published, to determine the range of patent claims that may be asserted by an NDA holderor patent
`owner.
`
`Patent and Exclusivity for: N200603
`
`Product 004
`
`LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 120MG
`
`Patent Data
`
`
`
`Product
`No
`
`Patent No
`
`Patent
`Sedeeel]
`
`Tatelect
`Claim
`
`Drug Product
`Claim
`
`teeta ty
`Code
`
`reteg
`Requested
`
`oo4
`
`004
`
`oo4
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`oo4
`
`5332372
`
`Jul 2, 2018
`
`DS
`
`5532372*PED Jan 2, 2019
`
`
`
`8729085
`
`May 26, 2026
`
`8729085*PED Nov 26, 2026
`
`8883794
`
`May 26, 2026
`
`8883794*PED Nov 26, 2026
`
`9174975
`
`Jun 25, 2026
`
`9174975*PED Dec 25, 20276
`
`9259423
`
`May 23, 2031
`
`9259423*PED Nov 23, 2031
`
`DP
`
`DP
`
`U-1770
`
`U-1822
`
`9555027
`
`May 26, 2026
`
`DP
`
`U-543
`
`RE45573
`
`Jun 23, 2025
`
`DS
`
`RE45573*PED Dec 23, 2025
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 009
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 009
`
`

`

`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book database.
`
`
`
`
`iew a list of all patent use co
`
`
`‘Ww a list of all exclusivity co
`
`Note: If you need help accessing information in differentfile formats, see Instructions for Downloading Viewers and Players.
`
`Language Assistance Available: Espafiol | $8832 | Tiéng Viat | S+=-0] | Tagalog | Pyccxwii | 4.=!|| Kreydl Ayisyen | Francais | Polski | Portugués| Italiano | Deutsch | R688 ||
`English
`
`Website Policies
`
`ae)Fey
`
`No FEAR Act
`
`Site Map
`
`Ta)gesmELC
`
`vi
`
`Careers
`
`FDA Basics
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA, (1-888-463-6332)
`
`eee aay
`9060
`
`[iube}
`
`5
`
`@ FDA Archive
`
`A Emergency Preparedness.
`
`j™ Federal, State & Local Officials
`
`8» Combination Products
`
`@ Intemational Programs
`
`& Consumers
`
`Advisory Committees
`“semen
`
`Regulatory Information
`
`@ Safety
`
`fi News & Events
`“venus
`
`Training & Continuing Education
`
`@ Inspections & Compliance
`
`Health Professionals
`
`A Science & Research
`
`# Industry
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 010
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 010
`
`