`INACTIVE ‘
`.
`
`INGREDIENT GUIDE
`
`mmum‘
`
`'
`
`'—
`.
`— .._.___.__
`_E&EEW&:3‘
`
`
`
`
`
`DIVISION OF
`
`-
`
`DRUG INFORMATION RESOURCES
`
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION'AND RESEARCH
`OFFICE OF MANAGEMENT
`
`JANUARY 1996
`
`-— OFFICIAL USE ONLY—1
`
`
`
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 1
`
`

`

`
`
`JNACTIVE INGREDIENT GUIDE
`
`Purpose The Inactive Ingredient Guide contains aii inactive ingredients present in approved drug products or conditionaiiy
`approved drug products currently marketed for human use. The Guide is compiied by the Division of Drug information
`Resources iDDiR),
`it provides CDER/CBER Reviewers with information on inactive ingredients in products which have been
`approved by the Agency. Once an inactive ingredient appears in a currently approved drug product for a particuiar route of
`administration, the inactive ingredient wouid not usuaiiy be considered new and may require a iess extensive review.
`
`Design The Inactive ingredient Guide has been sorted first aiphabeticaiiy by ingredient, and then by route of administration
`and dosage form. Routes of administration and dosage forms are derived from current approved iabeiing.
`
`“inactive
`21 CPR 210.3(bii8,7, respectiveiy) defines inactive ingredients and active ingredients as follows:
`Definitions
`ingredient means any component other than the active ingredient. Active ingredient means any component that is intended
`to furnish pharmacoiogicai activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
`or to affect the structure or any function of the body of man or animais. The term {active ingredient) inciudes those
`components that may undergo chemicai change in the manufacture of the drug product and be present in the finished drug
`product in a modified form intended to furnish the specified activity or effect." As an exception of the CPR definition, inactive
`ingredients listed in the Guide inciude oniy those which are present in the finai dosage form of the drug product.
`9
`Synonyms DDiR maintains a dictionary of aii ingredients contained in submissions to CDER. Since many ingredients have
`synonyms (which do not appear in the lnact/ve Ingredient Guide), it may assist you to contact vow Drug information Officer
`if you cannot find a particuiar inactive ingredient.
`
`DDiFi does not aiways inciude the components of proprietary inactive ingredients {eg .
`Proprietary inactive ingredients
`OPACODES].
`in such situations where components of proprietary %nactive ingredients are included, you may have to search
`for such data under individuai component entries.
`
`Warnings The inactive Ingredient Guide iists inactive ingredients specificaiiy intended as such by the manufacturer, Some
`of these inactive ingredients couid 3150 be considered as active ingredients under different circumstances isee 21 CFR
`210,3ibii7,3ii. Furthermore, reactants in radiopharmaceuticai kits, or inactive ingredients which physicaiiy or chemicaiiy
`combine with active ingredients to faciiitate drug transport are considered 'as inactive ingredients for the purposes of this Guide.
`
`iContinuedi
`
`
`
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 2
`
`

`

`
`
`Contaminants The /nact7ve Ingredient Guide does not represent contaminants found in approved drug products.
`
`if any of the inactive ingredients represented in the Inactive Ingredient Guide are proven to be
`Carcinogens and Teratogens
`carcinogenic, teratogenic, or embryotoxic, please notify DDlFl immediately. DDiR will attempt to relay your concern to each
`medical officer and pharmacologist reviewer responsible for oversight of other approved drug products which contain the
`specified inactive ingredient.
`
`CAS Number Many inactive ingredients have Chemical Abstracts Service lCA§i numbers associated with them. These can
`be found in the column to the right of the inactive ingredient. CAS numbersmay be helpful to CDER/CBER Reviewers when
`initiating computer-assisted searches with the National Library of Medicine‘s‘online data bases.
`
`Qualitative NDA Data The next five columns to the right of the CA8 number'serve to quality the data presented. The NBA
`
`CT‘ reflects the total number of NDAs in which a particular inactive ingredient Errently appears. The 'Last NDA' specifies
`which NDA was the most recent one to be approved by the Agency with this;inactive ingredient, The ‘APPROVAL DATE' and
`'DIV' specify the approval date and Review Division responsible for evaluating this most recent NBA. The ’POTENCY RANGE'
`specifies the minimum and maximum amounts of inactive ingredients for each route of administration and dosage form,
`ln
`some cases, values in the ‘POTENCY RANGE' column have been collapsed into percentage of the total product in order to
`integrate data.
`
`Colors The Certification Branch of the Division of Color Technology has designated permanently listed, provisionally listed,
`and delisted color additives. These appear in the Appendix. Please consult the 21 CFR 74 and 82 for detailed information on
`uses, restrictions, and tolerances of color additives.
`.,
`
`inactive ingredient Structures Chemical structures of all inactive ingredients which have been submitted to the Agency are
`available for review by contacting Rona Sun or Kyung Kim, DDlFl Chemists, at 443-3910
`
`The Division of Drug information Resources can also provide you with more
`Procedure for Obtaining Further Assistance
`specialized searches on the automated data base from which the Inactive Ingredient Guide is generated. For assistance in using
`the Guide, to schedule a presentation on the Guide, or for a more detailed search, contact your DDIR Drug information Officer
`on the following page or Mark Askine at 443—0500.
`
`EE
`EgE
`Er
`
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 3
`
`

`

`
`
`DIVISION OF DRUG INFORMATION RESOURCES
`
`DRUG INFORMATION OFFICERS
`
`Division of Cardio-Renai Drug Products, HFD—i ‘i O ............................ Diane Centeno-Deshieids, R.Ph,
`
`Division of Neuropharmecoiogicai Drug Products, HFD~i 20 ..................... Diane Centeno-Deshields, FLPh.
`
`Division of Oncologlc Drug Products, HFDW 50
`
`......... ............................ Sharon Browneweii
`
`Division of Medical Imaging, Surgicai, and Dental Products, HFD-‘iSO ...... I. .............. Herbert Thornton, RPh,
`
`Division of Anesthesic, Critical Care, and Addiction Drug Products, RFD-170 .................... Mary Guilderson
`
`Division of Gastrointestinai and Coagulation Drug Products, HFD-i 80 ....................... Richard Lipov, R.Ph
`
`1
`Division of Metabolism and Endocrine Drug Products, HFDA51O ........................... Ronald Brown, Ri‘h,
`
`Division of Anti-infective Drug Products, HFD—SZO .
`
`.
`
`i
`
`,
`
`A
`
`, ,,,,,,,,,,,,,,,,,,,,,,,,,,, Mark W. Askine, RPh,
`
`Division of Antiviral Drug Products, HFDA63O
`
`........................................ Lee Anne Parsons
`
`Division of Dermatologic and Ophthaimoiogic Drug Products, HFD~54O
`
`................... Mark W, Askine, RiPh
`
`Division of Anti»lnflammatory, Anaigesic, and Dental Drug Products, HFD-SSO ,
`
`.
`
`.
`
`.
`
`A
`
`.
`
`i
`
`,
`
`,
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`t
`
`i
`
`. Mary Guilderson
`
`Division of Pulmonary Drug Products, HFD-67O ...................................... Sharon Brownewell
`
`Division of Generic Drugs, HFD-BOO .......................... ,................... Janet Anderson, RPh.
`
`All DDIR Drug Information Officers can be contacted at 443-0500 and are iocated in Room 218 of the Chapman Building
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 4
`
`

`

`
`
`INACTIVE INGREDIENT FIELD DESCRIPTION
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACACIA
`
`BUCCALISUBLINGUAL: TABLET
`ORAL: CAPSULE
`ORAL: CAPSULE, SUSTAINED ACTION
`OFIAL: POWDER
`
`CAS#
`
`009000015
`
`ingredient Chemicai substance added to enhance Iormuiatinn o: g'ver‘r
`dosage forms. Camponerit of product cther than active ingredient,
`
`Route/Dosage Form Formuiation intended for the specified route ci
`administration or site of application.
`
`CASk‘ Registry number assigned to a command by Chemica! Abstracts
`Service on a random basis.
`
`NDA
`COUNT
`2
`1
`1
`1
`
`LAST
`NDA
`N85125
`Naszss
`N17078
`N16640
`
`APPROVAL
`DATE
`02/02/77
`04/01/77
`08/02/76
`08/03/73
`
`DIVISION
`600
`600
`120
`510
`
`POTEMCVI
`RANGE
`4.0 . 9.1 MG
`
`0,01 -o.7 MG
`21.0%
`
`NDA Count Reflects total number of approved NDAS in whicha parti~
`particuiar inactive ingredient currently appears.
`
`Last NDA Speciiies which NDA was the most recent one tn be
`approved by the Agency with this active ingredient.
`
`Approvai Date and DIV Specifies the approval date and the Review
`Division responsibie for evainetirg this most recent NDA.
`
`Speciiies the minimum and maxrmum amounts of
`Potency Range
`inactive ingredients for each 'outeidusage icrm.
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 5
`
`

`

` INACTIVE INGREDIENTS
`
`FOR CURRENTLY MARKETED DRUG PRODUCTS
`CA5 A
`NBA
`LAST
`NDA
`COUNT
`
`APPROVAL
`DATE
`
`DIV
`
`PDTENCV RANGE
`
`03/08/08
`
`09/29/95
`07/29/92
`02/25/92
`UO/Ib/HJ
`03/31/81
`01/04/95
`10/01/76
`05/29/76
`
`«no
`
`600
`600
`600
`600
`UHK
`600
`510
`510
`
`0,036H
`3.22HG ' 80.0MG
`0‘02MG ~ 156.0HG
`0.04MB ~ 0.08MB
`11.542MG
`2 OHS ‘ SATQMG
`1.26MB
`1.26MB
`
`07/09/80
`07/31/90
`03/25/94
`
`510
`600
`160
`
`010462
`0.027% ~ 0.44%
`
`05/02/88
`ua/xq/95
`
`05/01/18
`05/02/88
`05/07/78
`03/17/94
`IU/Zl/9b
`
`600
`bUU
`
`bUU
`600
`600
`UNK
`
`510
`
`0.135% - OIZSZ
`0.01% ‘ 0.48%
`
`0.006% - 0.00422
`0.01% - 0.225Z
`0.12% - 0.435X
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ACACIA
`BUCCAL/SUBLINGUAL; TABLET
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; PONDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET (IMHED.ICOHP. RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION; ENTERIC COATEE
`ORAL; TABLET, FILM COATED
`ORAL: TABLET, REPEAT ACTION
`ORAL) TABLET, SUSTAINED ACTION
`ORAL-21: TABLET
`ORAL-281 TABLET
`ACACI A HUCI LAGE
`ORAL; TABLET, COATED
`ACETIC ACID
`IH - IV - SC;
`INJECTION
`IN — SC;
`INJECTION
`INTRAHUSCULARJ
`INJECTION
`INTRAVENOUS}
`INJECTION
`IV(INFUSION);
`INJECTION
`OPHTHALMIC] POHDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`SUBCUTANEOUS;
`INJECTION
`TOPICAL} SOLUTION
`TOPICAL: SPONGE
`ACETIC ACID, GLACIAL
`IN - IV - SC; POWDER, FOR INJECTION SOLUTION
`1H — IV;
`INJECTION
`IN ‘ IV; POWDER, FOR INJECTION SOLUTION
`IM - SC;
`INJECTION
`
`.
`
`NTRA-ARTICULAR;
`INJECTION
`IN - SC;
`INJECTION, SUSTAINED ACTION
`INTRAHUSCULAR;
`INJECTION
`INTRASYNOVIALI
`INJECTION
`INTRAVENOUS} INJECTION
`IRRIGATION; SOLUTION
`IV(INFUSION)} INJECTION
`IV(INFUSIDN); POWDER, FOR INJECTION SOLUTION
`IVIINFUSION); SOLUTION,
`INJECTION
`NASAL; SOLUTION
`NASAL} SPRAY, NETERED
`OPHTHALMIC; SOLUTION
`ORAL; CAPSULE. HARD GELATIN
`
`009000015
`
`008047389
`
`000064197
`
`PAGE 1
`
`m
`
`
`
`H“wawwwpwuoqupmwwawwmouwwHnNmmuwwmmwNHwHwN
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 6
`
`

`

`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS %
`NDA
`LAST
`COUNT
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`000064197
`
`000108247
`000540921
`
`i
`
`000616911
`
`ACETIC ACID, GLACIAL
`ORAL; CONCENTRATE
`ORAL; SOLUTION, ELIXIR
`OTIC; SOLUTION
`OTIC; SUSPENSION
`SUBCUTANEOUS;
`INJECTION
`ACETIC ANHYDRIDE
`ORAL; TABLET, SUSTAINED ACTION
`ACETONE SODIUM BISULFITE
`DENTAL;
`INJECTION
`INHALATION; SOLUTION
`NERVE BLOCK)
`INJECTION
`ACETYL TRIBUTYL CITRATE
`ORAL; CAPSULE, ENTERIC COATED PELLETS
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET, ENTERIC COATED PARTICLES
`ORAL; TABLET, SUSTAINED ACTION
`ACETYLATED HONOGLYCERIDES
`INTRAVENOUS;
`INJECTION
`ORAL; CAPSULE. SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ACETYLCYSTEINE
`INHALATION; SOLUTION
`‘ACRYLATES COPOLYMER
`TRANSDERMAL; FILM. CONTROLLED RELEASE
`ADCOTE 72A103
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`AEROSIL 380
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`AEROSIL-ZDO
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`AEROTEX RESIN 3730
`TRANSDERNAL; FILM, CONTROLLED RELEASE
`AIR
`
`INHALATION; GAS
`ALBUMIN AGGREGATED
`INTRAVENOUS;
`INJECTION
`ALBUHIN COLLOIDAL
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`
`
`
`.
`i
`%
`
`III
`
`.
`
`PAGE 2
`
`1
`
`
`
`NmIwmuHNoHwHauawmwwwNHHwmmwHNNHHN
`
`12/16/85
`
`600
`
`0.075% - 0.12
`
`r\\;
`
`11/06/85
`06/12/91
`
`600
`510
`
`0.362
`0.22
`
`.
`06/30/81
`11/15/79
`
`.,.
`600
`600
`
`_
`,
`0.42 - 0.500342
`0.12 - 0.22
`
`01/10/92
`
`110
`
`2.0MG - 9,0MG
`
`bUU
`Ud/Zl/91
`04/26/78 600
`03/29/82
`500
`02/02/87
`600
`05/14/05
`UNK
`11/22/88 600
`
`0.04MB - 2.7MG
`
`.92MG - 5.17MG
`.OQMB - 2.1HG
`
`ON
`
`08/17/88
`02/02/87
`
`600
`600
`
`0.1HG - 910MB
`3.6MG - 7.2MG
`1
`
`10/01/82
`
`12/30/87
`
`160
`
`160
`
`010252
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 7
`
`

`

` INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG ERODUCTS
`
`CAS 3
`
`009006535
`
`000064175
`
`1
`
`000060175
`
`PAGE 3
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`9
`1
`1
`4
`21
`1
`5
`,1
`1
`3
`1
`3
`2
`1
`1
`13
`28
`23
`18
`35
`
`1
`
`Lu
`
`w
`
`12/28/90
`
`510
`
`0.052 - 1.2K
`
`12/28/95
`01/29/93
`
`12/28/39
`
`02/10/94
`
`08/50/95
`12/31/86
`
`08/30/91
`11/17/95
`04/29/93
`09/15/95
`10/28/96
`11/17/36
`06/18/90
`07/03/85
`02/27/95
`09/29/95
`
`600
`600
`
`UNK
`
`600
`
`600
`110
`
`600
`530
`600
`160
`600
`500
`UNK
`500
`600
`510
`
`10.0% - 12.252
`8.55% - 11.02
`
`au.un ~ 38.02
`
`6.82 « 30.5z
`
`0.61% - 52.9%
`10.02 ~ 30.02
`
`0.019% A 71.6%
`0.23% - 30.02
`5.0% — 20.4%
`0.0000067X ~ 7.25%
`0.5% - 7.5%
`
`52.02
`71.02 ~ 80.52
`33.02 — 83,02
`
`111/13/117
`uu/Zb/Bc
`11/30/89
`07/11/95
`08/30/95
`
`1501]
`unn
`UNK
`600
`600
`
`11.1112 ~ 111m
`1.02 - 30.5082
`10,0Z
`3.02 - 50.02
`10,02 A 80.0%
`
`10/11/33
`11/30/94
`07/14/95
`01/25/82
`06/18/87
`11/22/85
`
`600
`600
`530
`600
`600
`600
`
`0.52
`0.000032 - 7.37%
`0.12 ~ 24.92
`12.02 - 20.0Z
`0.262 — 1.02
`5.02 - 7.0%
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ALBUMIN HUMAN
`INJECTION
`INTRAVENOUS:
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`ALCOHOL
`DENTAL; SOLUTION
`IH - IV;
`INJECTION
`INJECTION
`I” ~ 1V1 SOLUTION,
`INHALATION; AEROSOL, METEREO
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`IV - SC)
`INJECTION
`IV(INFUSION);
`INJECTION
`IV(INFUSION); SOLUTION,
`OPNTHALMIC; SOLUTION
`ORAL; AEROSOL SPRAY
`ORAL; CONCENTRATE
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`RECTAL; SUSPENSION
`TOPICAL: AEROSOL SPRAY
`TOPICAL; GEL
`TOPICAL) LOTION
`TOPICAL; SOLUTION
`TRANSDERHAL; FILM, CONTROLLED RELEASE
`VABINALJ EMULSION, CREAM
`ALCOHOL, DEHYDRATED
`IH -
`IV;
`INJECTION
`IM - IV} POHDER, FOR INJECTION SOLUTION
`INHALATION; AEROSOL, HETERED
`INTRAHUSCULAR;
`INJECTION
`INTRAVASCULAR;
`INJECTION
`INTRAVENOUS}
`INJECTION
`IV(INFUSION)3 INJECTION
`IV(INFUSION)1 POHDER, FOR INJECTION SOLUTION
`IV(INFUSION); SOLUTION;
`INJECTION
`NASAL; AEROSOL SPRAY
`NASAL; AEROSOL, HETERED
`OPHTHALMIC; SOLUTION
`ORAL; CONCENTRATE
`ORAL: SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`
`INJECTION
`
`.
`
`.
`
`‘
`
`1
`;
`i
`g
`;
`E
`1
`1
`;
`1
`E
`E
`
`EE
`
`
`
`.
`E
`é
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 8
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CA5 R
`NDA
`LAST
`COUNT
`NDA
`
`
`
`ALCOHOL, DEHYDRATED
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SHAB
`ALCOHOL, DENATURED
`DENTAL} GEL
`DENTAL; PASTE
`TOPICAL; AEROSOL
`TOPICAL) EMULSION, AEROSOL FOAM
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SHAB
`ALCOHOL, DILUTED
`IM -
`IV} INJECTION
`ORAL; SOLUTION
`ORAL; SOLUTION; ELIXIR
`ORAL} SUSPENSION
`ORAL; SYRUP
`TOPICAL; AEROSOL SPRAY
`TOPICAL; POHDER, FOR RECONSTITUTION
`ALGINIC ACID
`OPHTHALMIC} DRUG DELIVERY SYSTEM
`OPHTHALMIC} SUPPOSITORV,
`INSERT, CONTROLLED RELEASE
`ORAL: CAPSULE
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`ORAL; TABLET. COATED
`ORAL} TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ALKYL AMMONIUM‘SULFONIC ACID BETAINE
`TOPICAL; SPONGE
`ALKYL ARYL SODIUM SULFONATE
`TOPICAL) SUSPENSION; SHAMPOO
`ALLANTOIN
`TOPICAL: GEL
`VABINAL; EMULSION, CREAM
`ALTHEA
`ORAL; SUSPENSION
`ALUMINUM ACETATE
`OTIC; SOLUTION
`TOPICAL: EMULSION. CREAM
`TOPICAL; SHAMPOO
`ALUMINUM HYDROXIDE
`TOPICAL; EMULSION. CREAM
`TOPICAL; OINTMENT
`
`000064175
`
`008024451
`
`008000166
`
`009005327
`
`000097596
`
`000139121;
`
`001302290
`
`PAGE 4
`
`{ll
`
`APPROVAL
`DATE
`
`01/29/93
`9?/?§K90
`
`10/26/84
`01/11/91
`07/30/93
`
`05/16/79
`Ud/ZIIIB
`
`DIV
`
`600
`600
`
`UNK
`600
`600
`
`600
`600
`
`POTENCY RANGE
`
`20.02 * 94,7808X
`55.0% ~ 77.02
`
`75.352 - 96.93852
`44,02 ~ 60.16%
`75‘0Z
`
`6.91752
`
`0.5% ' 1.5K
`
`05/14/36
`12/29/94
`06/28/89
`U9/U3/BO
`
`600
`110
`ann
`
`600
`
`17.0MG
`0,07MG - SOAOMG
`1R0.0MG - 400.0MG
`16.800MG * 52‘8MG
`
`
`
`
`
`HMHMNNHHHH‘NHND—‘v—iNU‘NHHHHH015
`
`p—n
`
`
`
`N£\huuwHHF!H
`
`12/22/87
`10/10/85
`
`600
`600
`
`5.02
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 9
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CA5 fl
`NBA
`LAST
`COUNT
`NDA
`
`ALUMINUM HYDROXIDE - SUCROSE, HYDRATED
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL
`TOPICAL: EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL F 500
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL F 5000
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL. DRIED
`ORAL; TABLET
`ALUMINUM OXIDE
`ORAL; TABLET
`ALUMINUM POLYESTER
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`ALUMINUM POTASSIUM SULFATE
`VAGINAL; SUPPOSITORY
`ALUMINUM SILICATE
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`TOPICAL; SUSPENSION, SHAMPOO
`ALUMINUM STARCN OCTENYLSUCCINATE
`TOPICAL; EMULSION. CREAM
`ALUMINUM STEARATE
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`TOPICAL; EMULSION. CREAM
`TOPICAL; OINTMENT
`ALUMINUM SULFATE
`OTIC; SOLUTION
`TOPICAL; EMULSION, CREAM
`ALZAMER-SO
`ORAL} TABLET, SUSTAINED ACTION
`AMBERLITE
`ORAL) CAPSULE
`ORAL; TABLET
`ORAL; TABLET, COATED
`1 ORAL; TABLET, FILM COATED
`AMERCHOL L101
`TOPICAL; EMULSION, CREAM
`AMERCHOL-CAB
`OPHTHALMIC; OINTMENT
`AMMONIA
`INHALATION; LIQUID
`AMMONIA SOLUTION
`ORAL; SUSPENSION
`
`b—IHHHHHHHNNDH
`NU‘HH‘OHHLP‘NMUD-U“
`
`012040594
`
`008012633
`
`001344281
`
`012141467
`
`007047809
`
`010043013
`
`009002191
`
`005029047‘
`007664417
`008007576
`
`PAGE 5
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`01/29/93
`10/08/85
`10/08/85
`
`600
`600
`600
`
`0,32 ~ 1.0%
`2.02
`3.0%
`
`10/29/93
`12/17/90
`02/25/94
`09/28/92
`
`UNK
`UNK
`600
`600
`
`12/21/90
`
`600
`
`1.0MG - 12.0MG
`
`08/25/89
`12/03/56
`
`UNK
`600
`
`110% - 5.0%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 10
`
`

`

`
`
`INACTIVE INGREDIENTS FDR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`AMMUNIUH ACETATE
`INJECTION
`INTRAMUSCULAR;
`INTRAVENOUS;
`INJECTION
`ANNONIUM CALCIUN ALGINATE
`ORAL; TABLET
`AMNONIUM CHLORIDE
`ORAL; TABLET
`AMMUNIUH NVOROXIOE
`INTRAVENOUS;
`INJECTION
`ORAL; CAPSULE
`INJECTION
`SUBCUTANEOUS;
`AHMONIUH PHOSPHATE, DIBASIC
`ORAL; TABLET
`AMMONIUM SALT 0F c—Iz—C-Is LINEAR PRIMARY ALCOHOL ETHOXYLATE
`TOPICAL; SPONGE
`AMNONIUM SULFATE
`IM -
`IV; PONOER, FOR INJECTION SOLUTION
`INTRAVENOUS; SUSPENSION,
`INJECTION
`IV(INFUSIONJ; PONOER. FOR INJECTION SOLUTION
`ANNOvi
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`AMPHOTERIC-Z
`TOPICAL; SUSPENSION, SHAMPOO
`AMPNOTERIC-s
`TOPICAL; EMULSION, CREAM
`ANETNOLE
`- OENTAL; SOLUTION
`ORAL; SOLUTION
`ORAL; SOLUTION. ELIXIR
`ANIDRISDRB 35/70
`ORAL; CAPSULE, SDFT GELATIN
`ANISE EXTRACT
`ORAL; SOLUTION, ELIXIR
`ANISE OIL
`ORAL; PASTILLE
`ORAL; SOLUTION, ELIXIR
`ORAL; susPENSION
`ANISE,
`sTAR
`.
`,
`ORAL; SOLUTION, ELIXI
`ANDXID SBN
`TOPICAL; EMULSION, CREAM
`ANTIPOAN
`ORAL; susPENsION
`TOPICAL; LOTION
`
`,
`
`1H
`
`‘
`
`v
`
`,
`
`CAS 8
`
`000631613
`
`012125029
`
`007703200
`
`007703202
`
`v
`
`004180230
`
`000100461
`
`000007703
`
`003051009
`
`PAGE 6
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`PDTENCY RANGE
`
`0404
`
`H
`
`Hwy-HHHw(ANob-as
`NHWNHNNU‘HHH
`
`NH
`
`1
`,
`
`é
`
`01/27/95
`01/27/95
`
`600
`600
`
`0.42
`0.GZ
`
`06/09/87
`
`600
`
`2.4MG - 4.2MG
`
`05/16/95
`
`600
`
`11/02/87
`
`600
`
`0.4MG
`
`0.0032
`
`30.045MG ~ 123.0MG
`
`I
`10/03/83
`
`84/20/95
`03/26/76
`
`600
`
`UNK
`600
`
`12/16/83
`
`600
`
`10/31/94
`
`600
`
`0.156252
`
`07/16/74
`
`600
`
`0.01% - 0.0312
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 11
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ANTIFOAM DC
`ORAL; PDHDER, FOR RECONSTITUTION
`ANTIPYRINE
`OPHTHALMIC; SOLUTION
`AOUACOAT
`ORAL} TAELET (IMMED./COMP. RELEASE), UNCOATED,
`AOUACOAT ECO
`ORAL; TABLET, FILM COATED
`AOUAPNOR
`TOPICAL; EMULSION, CREAM
`TOPICAL} OINTMENT
`ARGININE
`IM -
`IV} INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`ARLATONE 289
`TOPICAL; EMULSION, CREAM
`ASCORBIC ACID
`CAUDAL BLOCK;
`INJECTION
`EPIDURAL;
`INJECTION
`IM -
`IV;
`INJECTION
`INHALATION; AEROSOL, METEREO
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS:
`INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IVKINFUSION);
`INJECTION
`IU(INFUSION); POHDER, FOR INJECTION SOLUTION
`NERVE BLOCK;
`INJECTION
`ORAL} CAPSULE
`ORAL; CONCENTRATE
`ORAL; SUSPENSION, SUSTAINEO ACTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`RECTAL; SUPPOSITORY
`. SUBCUTANEOUS}
`INJECTION
`ASCORBYL PALHITATE
`ORAL; CAPSULE
`ORAL; TABLET
`RECTAL; SUPPOSITORY
`TOPICAL: EMULSION, CREAM
`ASPARTAHE
`ORAL; GRANULE. EFFERVESCENT
`ORAL; PONDER
`ORAL; PDHDER, FOR RECONSTITUTION
`ORAL} SYRUP
`
`-
`
`4
`
`CAS 3
`
`NBA
`COUNT
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`000060800
`
`008029150
`
`000050817
`
`000137666
`
`053906697
`
`1—:
`
`q
`
`1
`
`new
`
`
`
`
`
`HNHH>4mewHHmNHmHHNmemI—INNHHHMHDJHMN
`
`10/03/90
`
`600
`
`03/31/97
`
`11/07/95
`
`Ann
`
`600
`
`0,78% - 1.56%
`
`.22
`{1% * 0.20518Z
`.022 ~ 0,0382
`.12 ~ 0.22
`
`DECO
`
`0.05% F 0,22
`
`I‘DMG ' ZBOQQMG
`
`07/25/74
`12/28/8fi
`06/13/91
`04/15/83
`03/09/38
`
`02/16/H9
`10/27/83
`
`600
`UNK
`600
`600
`500
`
`500
`600
`
`snn
`06/?7/33
`11/15/82 600
`08/29/88
`600
`
`08/14/87
`
`600
`
`IZ/23/91
`
`520
`
`0.162 - 1.05%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 12
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`CAS 3
`
`053906697
`000056848
`008007474
`
`007727437
`
`001302799
`
`000100527
`008001545
`
`4
`
`:
`E
`3
`;
`;
`E
`
`E
`g
`;
`g
`;
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ASPARTAME
`ORAL: TABLET (IMHED./COMP. RELEASE), UNCOATED;
`ASPARTIC ACID
`IV(INFUSION);
`INJECTION
`BALSAH CANADA
`TOPICAL: LOTION
`BALSAH, FIR
`TOPICAL; OIL
`BARIUH SULFATE
`
`INSERT, CONTROLLED RELEASE
`BEE56:;RAUTERINE; SUPPOSITORY,
`ORAL} CAPSULE, SOFT GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TAaLET, anTEn
`TOPICAL] EMULSION, CREAM
`TOPICAL; OINTMENT
`BEESHAX. SYNTHETIC
`TOPICAL; EMULSION, CREAM
`BENTONITE
`ORAL; CAPSULE
`ORAL; SUSPENSION
`-
`ORAL; TABLET
`TOPICAL; SUSPENSION. SHAMPOO
`TRANSDERHAL; FILH, CONTROLLED RELEASE
`AGINAL; SUPPOSITORY
`BENZ LDEHYDE
`ORAL; SUSPENSION
`BENZALKONIUH CHLORIDE
`INHALATION; SOLUTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSAL;
`INJECTION
`INTRADERMAL:
`INJECTION
`INTRALESIONAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`NASAL; SOLUTION
`- NASAL} SPRAY
`NASAL; SPRAY, HETERED
`OPHTHALMIC; GEL
`OPHTHALMIC; OINTHENT
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL: LOTION
`TOPICAL: SHAMPOO
`TOPICAL; SOLUTION
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCV RANGE
`
`11/16/94
`02/18/94
`
`UNK
`180
`
`5.41MB - 40.GMG
`OTQK - 0.632
`
`ruHhLDm~quuohn~th~HyamHHF‘MFHQHwquumpaNwwHNu
`
`HH‘
`
`p—A
`
`7
`2
`
`11/22/95
`”9/13/39
`12/20/82
`06/30/92
`12/17/90
`
`150
`UNK
`600
`600
`UNK
`
`\I ASTQHG ~ 18‘16HG
`.UI/MG - 0.1HG
`AOZMG ~ 0.53MB
`.02
`40%
`
`mr<ac
`
`iO/ii/qn snn
`01/10/91
`600
`
`n any
`2.12
`
`05/28/93
`
`600
`
`0.01% - 0.025%
`
`10/20/95 UNK
`
`0,012 - 9,022
`
`09/29/95 600
`09/13/95
`600
`01/16/85
`600
`03/23/73 Ann
`04/11/19
`600
`
`a.aoooaz - 10.02
`0.001% - 0.025%
`0.012 — 0.02%
`0.12
`0‘012
`
`I”
`
`,.
`
`PAGE 0
`
`‘
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 13
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 9
`NBA
`, LAST
`COUNT
`NDA
`
`INJECTION
`
`000121540
`
`r—lv—lb—i
`
`07/16/81
`
`600
`
`0.01%
`
`H
`
`
`
`
`
`NHHU’LDHHNU‘MUIUU‘DH1—0-HANHDHOmanb-‘HbHme—u—n—w—u-Im
`
`9
`
`1
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`BENZENESULFONIC ACID SOLUTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; SOLUTION,
`IV(INFUSION);
`INJECTION
`BENZETHONIUM CHLORIDE
`1” - IV;
`INJECTION
`INTRAHUSCULAR;
`INJECTION
`INTRAVENOUS; PONDER, FOR INJECTION SOLUTION
`HV(INFUSION);
`INJECTION
`NASAL; SPRAY, HETERED
`OPHTHALMIC; POHDER, FOR RECONSTITUTION
`OPHTHALMIC) SOLUTION
`OTIC; SOLUTION
`BENZODODECINIUH BROMIDE
`OPHTHALMIC: SOLUTION
`BENZOIC ACID
`INJECTION
`IH ' IV;
`INTRAHUSCULAR;
`INJECTION
`IRRIGATION; SOLUTION
`IV(INFUSION);
`INJECTION
`ORAL} SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL; SYRUP
`ORAL; SUSPENSION
`ORAL} TABLET, COATED
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL} SUPPOSITORY
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BENZOIN
`ORAL) CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`BENZYL ALCOHOL
`EPIDURAL} INJECTION
`IH ~ IV - SC} INJECTION
`IN -
`IV;
`INJECTION
`IN -
`IV; POWDER, FOR INJECTION SOLUTION
`IN ‘
`IV; SOLUTION,
`INJECTION
`IH - SC;
`INJECTION
`IH‘- SC;
`INJECTION, SUSTAINED ACTION
`INTERSTITIAL;
`INJECTION
`INTRA-ARTERIAL;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSAL;
`INJECTION
`INTRACAVITARY;
`INJECTION
`INTRACAVITARY; POHDER, FOR INJECTION SOLUTION, LYOPHILI
`
`<
`
`007281041
`000065850
`
`y
`
`'
`
`009000059
`
`000100516
`
`PAGE 9
`
`'
`
`T"
`
`APPROVAL
`DATE
`
`DIV POTENCV RANGE
`
`»
`\\\
`
`\
`
`10/31/94
`
`600
`
`0.02%
`
`01/29/93
`
`600
`
`0,22 ' 5.02
`
`04/24/91
`10/10/86
`01/17/R9
`08/28/81
`{19/15/95
`“With/$3
`91/04/95
`
`0.1%
`120
`0.12
`550
`nv12
`snn
`0.12
`110
`um 0.72
`2(U
`600
`
`0,17.
`
`— 0.27;
`
`12/29/93
`06/30/94
`03/19/82
`03/05/90
`07/25/83
`07/14/87
`
`04/09/86
`02/13/74
`
`600
`600
`600
`600
`600
`600
`
`600
`500
`
`0.92 - 1.5%
`0.001% - 15.0%
`16.4MG - 66.9MG
`0.672% — 0.9452
`0.9% - 2.2%
`1.22
`
`0.001% ~ 1.0%
`0.9%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 14
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`, EENZYL OLCOHOL
`INJECTION
`INTRADERHAL;
`INTRALESIONAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAHUSCULAR; POWDER, FOR INJECTION SOLUTION
`INTRAHUSCULAR; SOLUTION.
`INJECTION
`INTRAPERITONEAL;
`INJECTION
`INTRAPLEURAL;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`INTRATHECAL;
`INJECTION
`INTRATUHOR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; POHDER, FOR INJECTION SOLUTION
`INTRAVENOUS; SOLUTION,
`INJECTION
`IV - SC;
`INJECTION
`IV(INFUSION);
`INJECTION
`IV(INFUSION); POHOER, FDR INJECTION SOLUTION
`IV(INFUSION); SOLUTION,
`INJECTION
`NERVE BLOCK;
`INJECTION
`ORAL; CAPSULE
`ORAL; CAPSULE. SOFT GELATIN
`ORAL; CAPSULE, SUSTAINEO ACTION
`ORAL; CONCENTRATE
`ORAL; SOLuTION
`ORAL; SUSPENSION
`ORAL; TABLET
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, SUSTAINED ACTION
`SOFT TISSUE;
`INJECTION
`SUBCOHJUNCTIVAL;
`INJECTION
`SUBCUTANEDUS;
`INJECTION
`SUBCUTANEOUS; PONOER, FOR INJECTION SOLUTION
`TOPICAL: EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL; OINTNENT
`TOPICAL; SOLUTION
`TOPICAL; SUPPOSITORY
`URETERALI SOLUTION
`VAGINAL; EMULSION, CREAM
`VACINAL; SUPPOSITORY
`BENZYL BENZOATE
`INJECTION
`INTRAHUSCULAR;
`BENZYL CHLORIDE
`INTRAVENOUS;
`INJECTION
`
`_
`
`,
`
`g
`'
`
`
`
`CAS 0
`
`000100516
`
`,
`
`000120514
`
`000100647
`
`PAGE 10
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`7
`
`1
`
`6
`
`1
`5
`
`3
`
`HHmrdUsb—IHHU-MDOb—IJ.‘b—Ibb—INOJHD-Ib—IxcMOKHHWNNIOHDNNHHHNNNIGN
`
`10/16/07
`10/16/87
`01/27/95
`02/27/55
`
`UNK
`UNK
`600
`UNK
`
`OIQZ
`0.92 - 1.02
`0.001% — 10.45%
`
`600
`02/17/84
`600
`05/09/06
`600
`05/09/86
`«On
`07/17/05
`UNK
`12/15/95
`600
`10/10/95
`600
`08/30/95
`500
`07/30/93
`520
`12/20/95
`unluc/uu- UNK
`
`0.92
`0.65% — 0.92
`0.652 - 0.9%
`n,0012 — 3.0x
`0.9% - 2,022
`0,9Z — 1.5%
`0.752 - 3.02
`
`1.231MG
`
`110
`01/05/89
`€7n
`06/19/05
`bUU
`Ub/Zfl/BZ
`”(lib/Db uuu
`
`uv/ZUIUD UNK
`12/07/92
`UNK
`10/09/85
`sou
`
`0.49MB ‘ 1.06MB
`n DANG - 2.31MG
`0.001Z - 0.92
`ULVA
`
`0.27 - 2,22
`0
`.72 ~ 1,0Z
`
`12/04/95
`
`600
`
`1.02
`
`07/30/81
`
`600
`
`0.012 - 46,02
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 15
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`OETA—NAPNTNOL
`ORAL; CAPSULE
`BORIC ACIO
`INJECTION
`INTRAVENOUS; SOLUTION,
`OPHTHALMIC; PONOER, FDR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL: SHAMPOO
`BUFFER. ACETIC ACIO-SOOIUM ACETATE
`IM - Iv - SC;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRASVNOVIAL;
`INJECTION
`IV(INFUSION);
`INJECTION
`BUFFER, CITRIC ACID-SODIUM CITRATE
`IM - Iv;
`INJECTION
`IvtINFUSION);
`INJECTION
`SUBCUTANEOUS; SOLUTION,
`BUTANE
`TOPICAL; AEROSOL SPRAY
`TOPICAL; EMULSION, AEROSOL FOAM
`BUTYL ALCOHOL, TERTIARY
`TOPICAL; GEL
`BUTYLATEO HYOROXVANISOLE
`INTRAMUSCULAR;
`INJECTION
`IV(INFUSION)J INJECTION
`NASAL; SPRAv, METEREO
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CONCENTRATE
`ORAL; GRANULE, FOR RECONSTITUTION
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`RECTAL; SUPPUSITDRY
`SUBLINOUAL; TABLET
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`TOPICAL; SUPPOSITORY
`UAOINAL; EMULSION, CREAM
`VAGINAL; OINTMENT
`VAGINAL; SUPPOSITORY
`BUTYLATED HYDRUXYTULUENE
`INHALATION; LIOUIO
`INTRAMUSCULAR;
`INJECTION
`IV(INFUSION);
`INJECTION
`NASAL; SPRAY, METEREO
`
`INJECTION
`
`,
`
`g
`é
`E
`
`,
`i
`;
`:
`
`.
`;
`;
`;
`
`”I
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 3
`NBA
`LAST
`COUNT
`NDA
`
`000135193
`
`POTENCY RANGE
`
`0.05% - 2.02
`0.62 - 1,02
`
`APPROVAL
`DATE
`01/13/76
`
`DIV
`600
`
`UNK
`04/02/63
`600
`12/29/95
`12/28/82 600
`02/25/94
`600
`
`11/26/82
`
`600
`
`08/08/85
`
`510
`
`0 00032
`
`11/22/95
`
`150
`
`0.1HG - 0,2MG
`
`10/31/91
`
`600
`
`O .DQMG - DISMG
`
`08/51/YZ 600
`04/16/81
`600
`12/23/82
`UNK
`09/30/83
`UNK
`04/26/93
`520
`01/04/95 Ann
`00/26/95
`520
`
`.Luzanu - 0.213019
`.SMG
`can:
`.OOSZZ
`.OOSX - 0.022
`3 “0‘72 — 0.00442
`1,0MG
`
`08/08/85
`
`510
`
`0.0012
`
`010043353
`
`000106978
`
`000075650
`003003245
`
`,
`
`000128370
`
`PAGE 11
`
`3
`
`h—l
`
`uptharawnpawHRHNMLNHN
`
`thawNPdOUVthUbP-mrn—NLAHPOH
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 16
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 8
`A
`ND
`LAST
`COUNT
`NOA
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`BUTYLATED HYDROXYTDLUENE
`ORAL: CAPSULE
`ORAL; CAPSULE. SOFT GELATIN
`ORAL; TABLET
`ORAL: TABLET. SUSTAINED ACTION
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL} EMULSION; CREAM
`TOPICAL; GEL
`TOPICAL: OINTMENT
`TOPICAL; SOLUTION
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BUTYLENE GLYCOL
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`BUTYLPARABEN
`INTRAMUSCULAR;
`INJECTION
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; DROPS
`ORAL; SOLUTION
`ORAL; SUSPENSION
`ORAL; SYRUP
`ORAL} TABLET
`ORAL) TABLET, COATED
`ORAL; TABLET. REPEAT ACTION
`ORAL; TABLET, SUSTAINED ACTION
`RECTAL) SOLUTION
`TOPICAL: EMULSION. CREAM
`TOPICAL)
`tOTION
`TOPICAL; DINTMENT
`CAFFEINE
`OPHTHALMIC; SOLUTION
`CALCIUM
`INJECTION
`IM - IV;
`INTRAMUSCULAR;
`INJECTION
`CALCIUM ACETATE
`' ORAL-21; TABLET
`ORAL-28; TABLET
`TOPICAL; EMULSION, CREAM
`CALCIUM ASCORBATE
`ORAL; SUSPENSION
`CALCIUM CARBONATE, PRECIPITATED
`ORAL; CAPSULE
`ORAL; CAPSULE. HARD GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`
`000128370
`
`000107880
`
`000094268
`
`000058082
`007440702
`
`000062544
`
`005743271
`
`000471341
`
`PAGE 12
`
`NNPHHNHmun»F“HN(NWOHHWDJNFHHDP‘HIHDHHbudNroN\naahdn~N
`
`0‘
`
`APPROVAL
`DATE
`
`nn/17/7n
`
`12/11/87
`05/31/72
`11/20/92
`10/05/78
`06/15/77
`05/04/77
`
`DIV
`
`R10
`
`500
`600
`
`UNK
`UNK
`UNK
`UNK
`
`POTENCV RANGE
`
`n nTAMG - n ?Mn
`0.1MG — U ENG
`
`0.0125MU - 0,215n6
`.uzz — 0.12
`.052
`1022
`.DEX
`
`DDOC
`
`12/20/95
`02/14/94
`
`520
`600
`
`09/26/74
`
`520
`
`0100582
`
`09/17/69
`03/31/81
`11/14/94
`uH/zy/yu
`12/17/81
`12/23/83
`
`120
`UNK
`UNK
`bUU
`600
`600
`
`04/12/88
`02/09/89
`09/28/92
`
`600
`600
`600
`
`30C)
`
`DOC
`
`mm
`
`.OOZBMG - 0.004MG
`.006MG
`TGGMG
`
`.21 - 0.4%
`.022
`.182 - 0‘32
`
`.OMG * 8.3MG
`.3MG ~ 10.0MG
`
`12/31/93
`
`510
`
`125.68MG - 224.7MG
`
`04/16/91
`
`600
`
`4.17MB - 00.0MG
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 17
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`CALCIUM CARBOHATE, PRECIPITATED
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET. FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-21; TABLET
`ORAL‘ZB; TABLET
`OTIC; SOLUTION
`CALCIUM CHLORIDE
`INJECTION
`CAUDAL BLOCK;
`EPIDURAL;
`INJECTION
`IM -
`IV;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAOCULAR; SOLUTION
`INTRAPERITONEAL; SOLUTION
`NERVE BLOCK;
`INJECTION
`OPHTHALMIC} POWDER, FOR RECONSTITUTION
`0 AL; CONCENTRATE
`0 AL; SUSPENSION
`SUBCUTANEOUS;
`INJECTION
`CALCIUM GLUCEPTATE
`INTRAVENOUS;
`INJECTION
`CALCIUM HYDROXIDE
`ORAL; SUSPENSION
`TOPICAL: EMULSION. CREAM
`CALCIUM LACTATE
`VAGINAL; TABLET
`CALCIUM PHOSPHATE
`ORAL: CAPSULE
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL: TABLET, FILM COATED
`ORAL; TABLET, REPEAT ACTION
`ORAL-21: TABLET
`ORAL-28; TABLET
`CALCIUM PHOSPHATE DIBASIC DIHYDRATE-SUCROSE AGGLOMERATE
`. ORAL; TABLET
`CALCIUM PHOSPHATE. DIBASIC
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; PASTILLE
`ORAL} SYRUP
`ORAL) TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, DISPERSIBLE
`
`’
`
`.
`
`CAS A
`
`000471341
`
`010035048
`
`017140602
`001305620
`
`000814802
`010103465
`
`1
`
`007757939
`
`PAGE 13
`
`y
`2
`%
`é
`é
`?
`é
`
`.
`
`HI
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`1
`
`07/25/92
`
`600
`
`0‘72MG - 64.8MG
`
`>-wnNNmHNE-amwwrunway-nun)
`
`
`N NHHDHDHHNNHNNH-bwuw
`
`,_.
`
`bur-l
`H
`
`N
`
`08/19/91
`
`UNK
`
`87.5MG " 229.7MG
`
`02/25/94
`
`600
`
`0,3822
`
`12/01/86
`04/07/88
`
`04/28/95
`
`12/01/60
`09/22/93
`04/27/33
`
`600
`finn
`
`bun
`
`bUU
`UNK
`gag
`
`0.033%
`n nnnz
`
`010481
`
`u.u24x - 0.0332
`
`0.008%
`
`11/18/93
`01/15/70
`n3/1:/7n
`
`12/30/81
`12/30/81
`
`04/10/84
`04/18/62
`
`11/30/95
`14/2u132
`
`1
`S
`1
`
`v>.~ :ao
`510
`510
`
`600
`120
`
`600
`bUU
`
`21.5MG - 160.0MG
`‘7 ‘MG - 362.0MG
`32.9MG - 86.0HG
`86.0MG
`7
`
`1,8MG - 2.4MG
`5.0HG — 234.04MG
`
`n nXIMn » 950.0HG
`55.0MG - 168.0MG
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 18
`
`

`

` INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`4
`2
`2
`4
`1
`
`1
`39
`3
`3
`1
`1
`9
`6
`1
`3
`1
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CALCIUM PHOSPHATE, DIBASIC
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-21; TABLET
`ORAL-281 TABLET
`TOPICAL; SHAMPOO
`CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET,