`INACTIVE
`INGREDIENT GUIDE
`
`
` raarernmmr
`
`a
`
`
`
`\
`a,
`7Aa
`
`DIVISION OF
`DRUG INFORMATION RESOURCES
`
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF MANAGEMENT
`
`JANUARY 1996
`
`— OFFICIAL USE ONLY —
`
`
`
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 1
`
`

`

`
`
`INACTIVE INGREDIENT GUIDE
`
`Purpose The inactive Ingredient Guide contains al! inactive ingredients present in approved drug praducts or conditionally
`approved drug praducts currently marketed for human use. The Guide is compiled by the Division of Drug Information
`Resources (DDIR}.
`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 particular route of
`administration, the inactive ingredient would not usually be considered new and may require a less extensive review.
`
`Design The Inactive ingredient Guide has been sorted first alphabetically by ingredient, and then by route of administration
`and dosage form. Routes of administration and dosage forms are derived from current approved fabeling.
`
`“Inactive
`21 CFR 210.3(b}/8,7, respectively) defines inactive ingredients and active ingredients as follows:
`Definitions
`ingredient means any component other than the active ingredient. Active ingredient means any componentthat is intended
`to furnish pharmacological activity or other direct effect in the diagnasis, cure, mitigation, treatment, or prevention af disease,
`or to affect the structure or any function of the body of man or animals. The term {active ingredient) includes those
`components that may undergo chemical change in the manufacture of the drug product and be presentin the finished drug
`product in a modified form intended to furnish the specified activity or effect.” As an exception of the CFR definition, inactive
`ingredients listed in the Guide include only those which are present in the final dosage form of the drug product.
`¥
`Synenyms ODIR maintains a dictionary of all ingredients contained in submissions ta CDER. Since many ingredients have
`synonyms (which do not appear in the /nactive ingredient Guide}, it may assist you to contact your Drug Information Officer
`if you cannotfind a particular inactive ingredient.
`
`ODIR does not always include the components of proprietary inactive ingredients {e.g.,
`Proprietary inactive ingredients
`OPACODES).
`In such situations where components of proprietary inactive ingredients are included, you may have te search
`for such data under individual component entries.
`
`Warnings The /nactive ingredient Guidelists inactive ingredients specifically intended as such by the manufacturer. Some
`of these inactive ingredients could also be considered as active ingredients under different circumstances {see 21 CFR
`210.3(b}7,3)). Furthermore, reactants in radiopharmaceutical kits, or inactive ingredients which physically or chemically
`combine with active ingredients to facilitate drug transport are considered as inactive ingredients for the purposes of this Guide.
`
`{Continued}
`
`
`
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 2
`
`

`

`
`
`Contaminants The /nactive Ingredient Guide does not represent contaminants found in approved drug products.
`
`If any of the inactive ingredients represented in the /nactive ingredient Guide are proven to be
`Carcinogens and Teratogens
`carcinogenic, teratogenic, or embryotoxic, please notify DDIR 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 (CAS} numbers associated with them. These can
`be found in the column to the right of the inactive ingredient. CAS numbers may be heipful to CDER/CBER Reviewers when
`initiating computer-assisted searches with the Nationa! Library of Medicine's online data bases.
`
`Qualitative NDA Data The next five columns to the right of the CAS numberserve to qualify the data presented. The NDA
`
`CT‘ reflects the total number of NDAs in which a particular inactive ingredient
`currently appears. Tha ‘Last NDA’ specifies
`which NDA was the most recent one to be approved by the Agencywith this: inactive ingredient. The ‘APPROVAL DATE’ and
`‘DIV’ specify the approva! date and ReviewDivision responsible for evaluating this most recent NDA. The ‘POTENCY RANGE’
`specifies the minimum and maximum amounts of inactive ingredients for each route of administration and dosage form.
`{n
`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 jisted, pravisionally 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 cclor additives.
`y
`
`Inactive ingredient Structures Chemical structures ofall inactive ingredients which have been submitted to the Agency are
`available for review by contacting Rona Sun or Kyung Kim, DDIR 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 /nactive ingredient Guide is generated. For assistance in using
`the Guide, to schedule a presentation on the Gu/de, or for a more detailed search, contact your DDIR Drug Information Officer
`on the following page or Mark Askine at 443-0500.
`
`
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 3
`
`

`

`
`
`DIVISION OF DRUG INFORMATION RESOURCES
`
`DRUG INFORMATION OFFICERS
`
`Division of Cardio-Renal Drug Products, HFD-110 . 2... eee Diane Centeno-Deshieids, 8.Ph,
`Division of Neuropharmacological Drug Products, HFD-120 .......,.,........... Diane Centeno-Deshields, R.Ph,
`Division of Oncologic Drug Products, HFD-150.......,,.. PO ee eee ete ne Sharon Brownewelil
`Division of Medical Imaging, Surgical, and Dental Products, HED-160...... tne eee ees Herbert Thornton, R.Ph.
`Division af Anesthesic, Critical Care, and Addiction Drug Products, HFD-170 ...,...........,..,... Mary Guilderson
`Division of Gastrointestinal and Coagulation Drug Products, HFD-180 «. 0. ee Richard Lipov, R.Ph
`Division of Metabolism and Endocrine Drug Products, HFD-510.....0.........0,...-50-0-.. Ronald Brown, 8.Ph,
`?
`Division of Anti-infective Drug Products, HFD-520 2.00.0... cece eee, Mark W. Askine, R.Ph.
`Division of Antiviral Drug Products, HFD-530 neces eee, Lee Anne Parsons
`
`.........,.......... Mark W. Askine, R.Ph
`Division of Dermatologic and Ophthalmologic Drug Products, HFO-540
`Division of Anti-Inflammatory, Analgesic, and Dental Drug Products, HFD-550 «0.0... 000.0..,00,. Mary Guilderson
`
`Division of Pulmonary Drug Products, HFD-570 2... ete c beeen, Sharan Brownewell
`
`Division of Generic Drugs, HFD-600.....0.. 0.0.00. cep eee eeyee Janet Anderson, R.Ph.
`
`All ODIR Drug Information Officers can be contacted at 443-0500 and are located in Room 218 of the ChapmanBuilding
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 4
`
`

`

`
`
`INACTIVE INGREDIENT FIELD DESCRIPTION
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACACIA
`
`BUCCAL/SUBLINGUAL; TABLET
`GRAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; POWDER
`
`CAS#
`
`cO3G0G015
`
`ingredient Chemical substance added to enhance formulation of given
`dosage forms, Component cf product ether than active ingredient,
`
`Route/Dosaga Form Formuiation intended for the specified route cf
`administration or site of application.
`
`CAS# Registry number assigned to a compaund by Chemica! Abstracts
`Service on a random basis.
`
`NDA
`COUNT
`2
`1
`1
`1
`
`LAST
`NBA
`N85125
`N85296
`N17078
`N16640
`
`APPROVAL
`DATE
`02/02/77
`04/01/77
`08/02/76
`08/03/73
`
`DIVISION
`600
`606
`120
`510
`
`POTENCY
`RANGE
`4.9-3.1MG
`
`0.01-0.7 MG
`21.0%
`
`NDA Count Reflects total number of approved NDAs in whicha parti
`particular inactive ingredient currently appears.
`
`Last NDA Specifies which NOA was the most recent one to be
`approved by the Agency with this active ingredient.
`
`Approwai Date and DiV Specifies the approval date and the Review
`Division responsible for evaluatirg this most recent NDA.
`
`Specifies the minimum and maximum amounts of
`Potency Range
`inactive ingredients for each route/dosage form,
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 5
`
`

`

`
`
`609000015
`
`008047389
`
`200064197
`
`PAGE 1
`
`wi
`
`be
`
`vet
`
`Ne
`
`DeheeCARUTEINEEREDAeeet
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`nasnasea
`
`09/29/95
`07/29/92
`02/25/92
`US/ 15/85
`03/31/81
`G1/04/95
`10/01/76
`03/29/76
`
`ang
`
`600
`600
`£00
`UNK
`600
`510
`516
`
`0.03GM
`3.22MG ~ 80.0MG
`0.02MG ~ 156.0MG
`6.04MG ~ 0.08MG
`11 .542HG
`2.0MG - 34.4MG
`1.264G
`1.26MG
`
`07/09/80
`07/31/90
`03/25/94
`
`510
`160
`
`0.046%
`8.027% - 0.44%
`
`05/02/88
`Ogs/14/95
`
`US/UIs 18
`05/02/88
`05/07/78
`03/17/94
`AUS ZI/9S
`
`6UU
`600
`600
`NK
`
`510
`
`0.135% - 0.25%
`B.01% - 0.48%
`
`0.006% - 0.0442%
`0.01% - 0.225%
`0.12% - 0.435%
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS #
`HDA
`LAST
`NDA
`COUNT
`
`ACAC
`
`'
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`IA
`BUCCAL/SUBLINGUAL ; TABLET
`AL; CAPSULE
`GRAL; CAPSULE, SUSTAINED ACTION
`GRAL; POWDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET CIMMED./COMP. RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, FILM COATED
`GRAL; TABLET, REPEAT ACTION
`3 TABLET, SUSTAINED ACTION
`ORAL-2Z1; TABLET
`ORAL-~28; TABLET
`ACACIA MUCILAGE
`ORAL; TABLET, COATED
`ACETIC ACID
`IM - IV -_SC3 INJECTION
`IM - SC; ENJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`IVCINFUSION) ;
`INJECTION
`GPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`SUBCUTANEOUS;
`INJECTION
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`ACETIC ACID, GLACIAL
`IM- I
`V - SC; POWDER, FOR INJECTION SOLUTION
`IM ~ IV;
`INJECTION
`IM ~ IV; POWDER, FOR INJECTION SOLUTION
`IM - SC;
`INJECTION
`iM ~ SC;
`INJECTION, SUSTAINED ACTION
`NTRA-ARTICULAR;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`INTRAVENOUS;
`INJECTION
`.
`IRRIGATION; SOLUTION
`IVCINFUSION);
`INJECTION
`IVCINFUSION); POWDER, FOR INJECTION SOLUTION
`IVCINFUSION); SOLUTION,
`INJECTION
`NASAL; SOLUTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; SOLUTION
`ORAL; CAPSULE, HARD GELATIN
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 6
`
`

`

`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS #
`LAST
`ND
`COURT
`NDA
`
`ACETIC ACID, GLACIAL
`GRAL; CONCENTRATE
`ORAL; SOLUTION, ELIXIR
`OTIC; SOLUTION
`OTIC; SUSPENSION
`SUBCUTANEOUS;
`INJECTION
`ACETIC ANHYDRIDE
`DORAL; TABLET, SUSTAINED ACTION
`ACETONE SODIUM BESULFITE
`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 MONOGLYCERIDES
`INTRAVENOUS;
`INJECTION
`ORAL; CAPSULE, SUSTAINEB 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-200
`ORAL; TABLET
`,
`ORAL; TABLET, FILM COATED
`AEROTEX RESIN 3730
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`AIR
`INHALATION; GAS
`ALBUMIN AGGREGATED
`INTRAVENOUS;
`INJECTION
`ALBUMIN COLLOIDAL
`INTRAVENQUS; POWDER, FOR INJECTION SOLUTION
`
`,
`
`
`
`ity
`
`0000646197
`
`900108247
`g00540921
`
`008616911
`
`PAGE 2
`
`nN=wwONOLDWONQeNeRRA
`
`ty
`
`~
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`12/16/85
`
`600
`
`0.075% - 0.1%
`
`.
`
`11/06/85
`06/12/91
`
`600
`510
`
`0.36%
`0.22%
`
`06/30/81
`11/15/79
`
`600600
`
`G.4% - 0.50034%
`0.1% - 0.2%
`
`01/10/92
`
`110
`
`2.0MG - 9.0MG
`
`UEs ers 9
`04726/78
`03/29/82
`92/02/87
`05/14/85
`11/22/88
`
`9.04MG - 2.7MG
`-92MG - 5.17MG
`-O4MG - 2.1MG
`
`on
`
`08/17/88
`02/02/87
`
`600
`600
`
`O.1MG - 9.0MG
`3.6MG - 7.2MG
`i
`
`10/01/82
`
`12/30/87
`
`160
`
`160
`
`0.025%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 7
`
`

`

`
`ReRGAOSheIBe
`passODATUNRReeDbRURe
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ALBUMIH HUMAH
`INTRAVENOUS ;
`INTRAVENOUS; POWDER, FOR INJECTION SCLUTIGN
`IVCINFUSION> ;
`ALCOHOL
`DENTAL; SOLUTION
`R
`IM ~ IV;
`IHJECTION
`IM -
`IV; SOLUTION,
`IMHALATION; AEROSOL, METERED
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INTRAVENOUS;
`INJECTION
`IV - $C} INJECTION
`IVCINFUSION);
`INJECTION
`IVCINFUSION) ;
`poEusdON.
`OERaatIC SOLUTIO
`AEROSOL SPRAY
`L;
`ORAL;
`CONCENTRATE
`ION
`ORAL s
`SGLUTION, ELIXIR
`GRAL ;
`NSION
`ORAL;
`A=mm
`UP
`ORAL;
`RECTAL; SUSPENSION
`TOPICAL; AEROSOL SPRAY
`TOPICAL; GEL
`TOPICAL; LOTION
`TOPICAL;
`FILM, CONTROLLED RELEASE
`TRANSDERMAL ;
`VAGINAL; EMULSION, CREAM
`ALCOHAL, DEHYDRATED
`IM - IV; POWDER, FOR INJECTION SOLUTION
`INHALATION; AEROSOL, METERED
`INTRAMUSCULAR;
`INTRAVASCULAR;
`INJECTION
`INTRAVENOQUS;
`INJECTION
`IVCINFUSION);
`INJECTION
`IVCINFUSION); POWDER, FOR INJECTION SOLUTION
`INJECTION
`IVCINFUSION}); SOLUTION,
`NASAL; AEROSOL SPRAY
`NASAL; AEROSOL, METERED
`OPHTHALMIC; SOLUTION
`ORAL;
`CONCENTRATE
`ORAL;
`ORAL ;
`ORAL;
`ORAL;
`
`
`
`.
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS &
`NDA
`LAST
`COUNT
`NDA
`
`INJECTION
`
`009006535
`
`900064175
`
`9000646175
`
`APPROVAL
`BATE
`
`DIV
`
`POTENCY RANGE
`
`‘
`
`12/28/90
`
`519
`
`0.05% - 1.2%
`
`12/28/95
`61/29/93
`12/25/84
`
`02/10/94
`
`UB/SU/95
`12/31/86
`
`08/30/91
`11/17/95
`04/29/93
`09/15/95
`10/28/94
`TL/17/R6
`06/18/90
`07/03/85
`02/27/95
`09/29/95
`
`10/13/87
`U4/ 25/82
`31/30/89
`O7/1L7/95
`08/30/95
`
`600
`600
`URKR
`
`600
`
`606
`116
`
`600
`530
`600
`180
`600
`and
`
`UNK
`600
`600
`510
`
`106.0% - 12.15%
`8.55% - 11.0%
`
`au.ua ~ 38.0%
`
`6.8% ~ 39,5%
`G.6i4% - 32.9%
`10.0% ~ 30.0%
`
`-O19% - 71.6%
`23% ~ 30.0%
`0% - 20.4%
`-OOG00867% ~ 7.25%
`“SX ~ 7.5%
`
`eanacg
`
`52.0%
`71.0% - 80.5%
`33.0% - 83.0%
`
`“600
`UnR
`UNK
`6uy
`600
`
`0.01% - 10.0%
`1.0% - 34,548%
`10.0%
`3.0% - 50.0%
`10.0% - 60,0%
`
`PAGE 3
`
`ed
`
`10/11/88
`11/30/94
`Q7/14/95
`01/25/82
`06/18/87
`11/22/85
`
`600
`
`530
`600
`600
`690
`
`0.5%
`0,G0003% - 7.37%
`G.1x - 24.9%
`12.0% - 20.0%
`0.26% - 1.0%
`5.0% - 7.0%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 8
`
`

`

`
`
`
`
`INGREDIENT
`ROUTE/BOSAGE FORM
`
`ALCOHOL, DEHYDRATED
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SWAB
`ALCOHOL, DENATURED
`DENTAL; GEL
`DENTAL; PASTE
`TOPICAL; AEROSOL
`TOPICAL) EMULSION, AERGSOL FOAM
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SWAB
`ALCOHOL, DILUTED
`IM -
`IV;
`INJECTION
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`GRAL; SUSPENSION
`QRAL; SYRUP
`TOPICAL; AEROSOL SPRAY
`TOPICAL; POWDER, FOR RECONSTITUTION
`ALGINIC ACID
`OPHTHALMIC; DRUG DELIVERY SYSTEM
`OPHTHALMIC; SUPPOSITORY,
`INSERT, CONTROLLED RELEASE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET (CIMMED./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; SUSPENSIGN, SHAMPOO
`ALLANTOIN
`TOPICAL; GEL
`VAGINAL; EMULSION, CREAM
`ALTHEA
`ORAL; SUSPENSION
`ALUMINUM ACETATE
`OTIC; SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; SHAMPOO
`ALUMINUM HYDROXIDE
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`
`089064175
`
`008024451
`
`008000166
`
`009005327
`
`000097596
`
`000139128
`
`001302290
`
`PAGE 4
`
`tre
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS &
`NDA
`LAST
`COUNT
`NDA
`
`APPROVAL
`DATE
`
`01/23/93
`09/28/90
`
`POTENCY RANGE
`
`Mo
`
`690
`600
`
`20.0% -~ 94,7B08%
`§5.9% - 77.0%
`
`10/26/84
`01/11/91
`07/30/93
`
`DS/1 6/79
`UBsZL/ 7B
`
`UNK
`600
`600
`
`406
`600
`
`75.35% - 96.9385%
`44.0% ~ 60.16%
`75.0%
`
`&.5T?7b67%
`
`9.5% - 1.5%
`
`UD/ 145/86
`12/29/94
`06/28/89
`UY/US/80
`
`6090
`110
`ann
`
`600
`
`17. 0MG
`0,07MG - 30.0MG
`TRO AMG - 400.0MG
`16.8045MG - 52,8MG
`
`tAGNDRDbteeNURRehRT
`
`-_
`
`NaMRReee
`
`12/22/67
`10/10/85
`
`400
`600
`
`5.0%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 9
`
`

`

`
`
`POUOAReeeeeNON
`
`ms
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`01/29/93
`10/08/85
`10/08/85
`
`600
`600
`600
`
`0.3% - 1.0%
`2.0%
`3.0%
`
`10/29/93
`12/17/90
`02/25/94
`09/28/92
`
`UNK
`UNK
`600
`666
`
`12/21/90
`
`600
`
`1.0MG - 12.0MG
`
`08/25/89
`12/03/86
`
`UNK
`600
`
`1.0% - 5.0%
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS #
`NDA
`LAST
`COUNT
`NDA
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ALUMINUM HYDROXIDE - SUCROSE, HYDRATED
`TOPICAL; EMULSION,
`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 STARCH OCTENYLSUCCINATE
`TOPICAL; EMULSION, CREAM
`ALUMINUM STEARATE
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; OLNTMENT
`ALUMINUM SULFATE
`OTIC; SOLUTION
`TOPICAL; EMULSION, CREAM
`ALZAMER-50
`ORAL; TABLET, SUSTAINED ACTION
`AMBERLITE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET, COATED
`. ORAL; Taptel FILM COATED
`AMERCHOL L190
`LertEMULSION, CREAM
`AMERCHOL-CA
`OPHTHALMIC; OINTMENT
`AMMONIA
`INHALATION; LIQUID
`AMMONIA SOLUTION
`ORAL; SUSPENSION
`
`012040594
`
`008012633
`
`001344281
`
`012141467
`
`007047849
`
`010043013
`
`009002191
`
`008029047"
`007664417
`608007576
`
`PAGE 5
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 10
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`NDA
`LAST
`COUNT
`NDA
`
`:
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`AMMONIUM ACETATE
`INJECTION
`INTRAMUSCULAR;
`INTRAVENOUS;
`INJECTION
`AMMONIUM CALCIUM ALGINATE
`ORAL; TABLET
`AMMONIUM CHLORIDE
`ORAL; TABLET
`AMMONIUM HYDROXIDE
`INTRAVENQUS;
`INJECTION
`ORAL; CAPSULE
`INJECTION
`SUBCUTANEOUS;
`AMMONIUM PHOSPHATE, DIBASIC
`ORAL; TABLET
`AMMONIUM SALT OF C-12-C-15 LINEAR PRIMARY ALCOHOL ETHOXYLATE
`TOPICAL; SPONGE
`AMMONIUM SULFATE
`IM -
`IV; POWDER, FOR INJECTION SOLUTION
`INTRAVENOUS; SUSPENSION,
`INJECTION
`IVCINFUSION); POWDER, FOR INJECTION SOLUTION
`AMMONYX
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`AMPHOTERIC-2
`TOPICAL; SUSPENSION, SHAMPOO
`AMPHOTERIC-6
`TOPICAL; EMULSION, CREAM
`ANETHOLE
`DENTAL; SQLUTION
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ANIDRISORB 85/70
`ORAL; CAPSULE, SOFT GELATIN
`ANISE EXTRACT
`ORAL; SOLUTION, ELIXIR
`ANISE OIL
`» ORAL; PASTILLE
`QRAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`ANISE, STAR.
`:
`ORAL; SOLUTION, ELIXIR
`ANOXID SBN
`TOPICAL; EMULSION, CREAM
`ANTIFOAM
`ORAL; SUSPENSION
`TOPICAL; LOTION
`
`APPROVAL
`DATE
`
`POTENCY RANGE
`
`01/27/95
`01/27/95
`
`600
`600
`
`06/09/87
`
`05/16/95
`
`6090
`
`600
`
`2.4MG - 4.2MG
`
`11/02/87
`
`606
`
`0.4MG
`
`0.003%
`
`30.045MG - 123.0MG
`
`1
`
`16/03/83
`
`04/20/95
`03/26/76
`
`600
`UNK
`600
`
`12/16/83
`
`400
`
`10/31/94
`
`97/16/74
`
`609
`
`600
`
`0.15625%
`
`0.01% - 0.031%
`
`CAS #
`
`33N
`
`RRNRRONUTRROitt
`
`Ne
`
`000631618
`
`012125029
`
`007783280
`
`007783202
`
`004180238
`
`0001046461
`
`008007743
`
`006051089
`
`PAGE 6
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 11
`
`

`

` INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`UNCOATED,
`
`INGREDIENT
`RGOUTE/DOSAGE FORM
`ANTIFOAM DC
`ORAL; POWDER, FOR RECONSTITUTION
`ANTIPYRIWE
`OPHTHALMIC; SOLUTION
`AQUACDAT
`ORAL; TABLET CIMMED./COMP. RELEASE},
`AQUACGAT ECD
`ORAL; TABLET, FILM COATED
`AQUAPHOR
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`ARGININE
`IM ~ IV;
`INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IVCINFUSION) ;
`INJECTION
`ARLATONE 289
`TOPICAL; EMULSION, CREAM
`ASCORBIC ACID
`CAUDAL BLOCK;
`INJECTION
`EPIDURAL;
`INJECTION
`IM -
`IV;
`INJECTION
`INHALATION; AEROSOL, METERED
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; POWDER. FOR INJECTION SOLUTION
`IVCINFUSIOND ; INJECTION
`IVCINFUSION); POWDER, FOR INJECTION SOLUTION
`NERVE BLOCK;
`INJECTION
`ORAL; CAPSULE
`ORAL; CONCENTRATE
`ORAL; SUSPENSION, SUSTAINED ACTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`RECTAL} SUPPOSITORY
`SUBCUTANEOUS;
`INJECTION
`ASCORBYL PALMITATE
`ORAL; CAPSULE
`ORAL} TABLET
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, CREAM
`ASPARTAME
`ORAL}; GRANULE: EFFERVESCENT
`ORAL; POWDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL; SYRUP
`
`CAS #
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`oogeé6oaoo
`
`008029150
`
`600050817
`
`000137666
`
`053906697
`
`_detAbetreOTetpeedeekhesONPA)betUDeeCAEtOedADedbottAbentadny
`
`19/03/90
`
`6ao
`
`O3/34/97
`
`Li/O7/95
`
`Ana
`
`600
`
`0.78% - 1.56%
`
`07/25/74
`12/28/84
`6/13/91
`04/15/88
`na/09/Ba
`
`O2Z/16/89
`10/27/83
`
`NG/PTSAR
`
`11/15/82
`08/29/88
`
`12n
`lA - 0.24518%
`02% ~ 0.038%
`AX ~ 0.2%
`
`eoa]a
`
`Ann
`
`6uu0
`600
`
`G.05% - 0.2%
`
`1,.0MG ~ 28.44MG
`
`08/14/87
`
`600
`
`12/23/91
`
`520
`
`0.46% - 1,05%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 12
`
`

`

`
`
`RELEASE), UNCOATED,
`
`INSERT, CONTROLLED RELEASE
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ASPARTAME
`ORAL; TABLET CIMMED./COMP.
`ASPARTIC ACID
`IVCINFUSION);
`INJECTION
`BALSAM CANADA
`TOPICAL; LOTION
`BALSAM, FIR
`TOPICAL; OIL
`BARIUM SULFATE
`INTRAUTERINE; SUPPOSITORY,
`BEESWAX
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TABLET, COATED
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`BEESWAX, SYNTHETIC
`TOPICAL; EMULSION, CREAM
`BENTONITE
`ORAL; CAPSULE
`ORAL; SUSPENSION
`ORAL; TABLET
`TOPICAL; SUSPENSION, SHAMPOO
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`AGINAL; SUPPOSITORY
`BENZALDEHYDE
`ORAL; SUSPENSION
`BENZALKONIUM CHLORIDE
`INHALATION; SOLUTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSAL;
`INJECTION
`INTRADERMAL ;
`INJECTION
`INTRALESIONAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`NASAL; SOLUTION
`- NASAL; SPRAY
`NASAL; SPRAY, METERED
`OPHTHALMIC; GEL
`OPHTHALMIC; OINTMENT
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL; LOTION
`TOPICAL; SHAMPOO
`TOPICAL; SOLUTION
`
`U8
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS #
`NDA
`LAST
`COUNT
`NDA
`
`ee
`
`ryNN:RODeeeOeeeeAORAeee
`
`053906697
`000056848
`008007474
`
`007727437
`
`001302789
`
`000100527
`008001545
`
`PAGE 8
`
`pReRovat
`DAT
`
`DIV
`
`POTENCY RANGE
`
`11/16/94
`02/18/94
`
`UNK
`180
`
`5.41MG ~- 460.0MG
`D.4% ~ 2,68%
`
`11/22/95
`UIs LIs BY
`12/20/82
`06/30/92
`12/17/90
`
`1asi7/90
`ULsAUs 91
`
`150
`UnK
`600
`
`UNK
`
`400
`
`600
`
`~~ -S79MG - 18.366
`-UL/MG ~ O.1MG
`-O2MG - 0.53N6
`0%
`
`0%Weos
`
`nh GhY
`
`05/28/93
`
`9.01% - 6.025%
`
`10/20/95
`
`0.01% - 0.02%
`
`09/29/95
`09/13/95
`01/16/85
`03/28/73
`
`O4/L1/749
`
`0.90004% - 10.0%
`0.901% - 0.025%
`0.01% - 0.02%
`QD.
`0.01%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 13
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS #
`NDA
`- LAST
`COUNT
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`07/16/81
`
`600
`
`0.81%
`
`16/31/94
`
`0.02%
`
`01/29/93
`
`600
`
`0.2% - 5.0%
`
`04/24/91
`10/10/86
`08/28/81
`O1/17/R9
`O92 3/95
`uUyN/Lo/93
`01/04/95
`
`0.1%
`0.1%
`0.1%
`
`D.Pn
`
`O.1% - 0.2%
`
`12/29/93
`06/30/94
`03/19/82
`03/05/90
`07/25/83
`07/16/87
`
`04/09/86
`02/13/74
`
`600
`600
`600
`600
`600
`600
`
`£06
`£00
`
`0.9% - 1.5%
`O.901% - 15.0%
`16.46MG - 66,9MG
`0.472% ~ 0.945%
`Q.9% - 2.2%
`1.2%
`
`O.001% - 1.0%
`0.9%
`
`111
`
`81i11116
`
`1
`14
`
`1118q
`
`3
`
`81412q1
`
`11
`
`13
`
`93
`
`53
`
`15
`
`211
`
`24
`
`511
`
`:
`
`?
`
`000121540
`
`007281041
`000065850
`
`009000059
`
`0001005136
`
`9
`
`INJECTION
`
`INGREDIENT
`ROUTE/BOSAGE FORM
`BENZENESULFONIC ACID SOLUTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; SOLUTION,
`IVCIRFUSION);
`INJECTION
`BENZETHONIUM CHLORIDE
`IM - IV;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IVCINFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`5
`TIC; SOLUTION
`BENZODODECINIUM BROMIDE
`OPHTHALMIC; SOLUTION
`BENZOIC ACID
`INJECTION
`M -
`IV;
`INTRAMUSCULAR;
`INJECTION
`IRRIGATION; SOLUTION
`IVCINFUSION);
`INJECTION
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`ORAL} TABLET, COATED
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL; SUPPOSITORY
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BENZOIN
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`BENZYL ALCOHOL
`INJECTION
`EPIDURAL;
`IM ~ IV - SC;
`INJECTION
`IM -
`IV;
`INJECTION
`IM -
`IV; POWDER, FOR INJECTION SOLUTION
`IM -
`IV; SOLUTION,
`INJECTION
`IM - SC;
`INJECTION
`IM - SC;
`INJECTION, SUSTAINED ACTION
`INTERSTITIAL;
`INJECTION
`INTRA-ARTERIAL;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSAL;
`INJECTION
`INTRACAVITARY;
`INJECTION
`INTRACAVITARY; POWDER, FOR INJECTION SOLUTION, LYOPHILI > AGE
`
`i
`
`i|
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 14
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`. BENZYL ALCOHOL
`INJECTION
`INTRADERMAL;
`INTRALESIOGWAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAMUSCULAR; POWDER, FOR INJECTION SOLUTION
`INTRAMUSCULAR; SOLUTION,
`INJECTION
`INTRAPERITONEAL;
`INJECTION
`INTRAPLEURAL;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`INTRATHECAL;
`INJECTION
`INTRATUMOR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`INTRAVENOUS; SOLUTION,
`INJECTION
`Iv - SC;
`INJECTION
`IVCINFUSION);
`INJECTION
`IVCINFUSION); POWDER, FOR INJECTION SQLUTION
`IVCINFUSION); SOLUTION,
`INJECTION
`NERVE BLOCK;
`INJECTION
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; CONCENTRATE
`ORAL; SOLUTION
`ORAL; SUSPENSION
`ORAL; TABLET
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, SUSTAINED ACTION
`SOFT TISSUE;
`INJECTION
`SUBCONJUNCTIVAL;
`INJECTION
`SUBCUTANEOUS;
`INJECTION
`SUBCUTANEOUS; POWDER, FOR INJECTION SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL; OINTMENT
`TOPICAL; SOLUTION
`TOPICAL; SUPPOSITORY
`URETERAL; SOLUTION
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BENZYL BENZOATE
`INJECTION
`INTRAMUSCULAR;
`BENZYL CHLORIDE
`INTRAVENOUS;
`INJECTION
`
`.
`
`.
`
`
`
`CAS #
`
`900106516
`
`/
`
`000120514
`
`000100447
`
`PAGE 10
`
`NDA
`COUNT
`
`7
`
`1
`
`6
`
`1
`5
`
`3
`
`3
`
`,
`
`SDPAMSWORDeemeRTRONNReeON
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`10/36/87
`10/16/87
`01/27/98
`02/27/85
`
`UNK
`UNK
`600
`UNK
`
`0.9%
`0.9% - 1.0%
`0.901% - 10.45%
`
`0.9%
`600
`02/17/84
`9.495% - 0.9%
`600
`05/09/86
`0.45% - 0.9%
`600
`05/09/86
`O7/17/95 én 1.001% ~ 3.0%
`12/45/95
`UNK O.9% - 2.02%
`10/10/95
`600
`0.9% - 1,5%
`08/30/95
`600
`0.75% - 3.0%
`07/30/93
`600
`
`520
`12/20/35
`UBsUC/BB- UR 1.231MG
`
`-49MG - 1.06MG
`110
`01/05/89
`06/19/95 Sn 30
`54M ~ 2.351MG
`Ubs2e/B2
`GUO
`U.UUI% - 0.9%
`ULI IOsOb
`suU U.FeA
`
`UYsZUs/9D
`12/07/92
`10/09/85
`
`UNA
`UNK
`600
`
`i)
`
`SN
`
`ao
`
`Nm
`
`12%
`
`12/06/95
`
`600
`
`1.0%
`
`07/30/81
`
`600
`
`0.01% - 46.0%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 15
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`NDA
`LAST
`COUNT
`WDA
`
`CAS #
`
`INJECTION
`
`BETA-HAPHTHOL
`ORAL; CAPSULE
`BORIC ACID
`INJECTION
`INTRAVENOUS; SOLUTION,
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL; SHAMPOO
`BUFFER, ACETIC ACID-SODIUM ACETATE
`IM -
`IV - SC;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`IVCINFUSION);
`INJECTION
`BUFFER, CITRIC ACID-SODIUM CITRATE
`IM - IV;
`INJECTION
`IVCINFUSION);
`INJECTION
`SUBCUTANEOUS; SOLUTION,
`BUTANE
`TOPICAL; AEROSOL SPRAY
`TOPICAL; EMULSION, AEROSOL FOAM
`BUTYL ALCOHOL, TERTIARY
`TOPICAL; GEL
`BUTYLATED HYDROXYANISOLE
`INTRAMUSCULAR;
`INJECTION
`IVCINFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CONCENTRATE
`ORAL; GRANULE, FOR RECONSTITUTION
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`RECTAL; SUPPOSITORY
`SUBLINGUAL; TABLET
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`TOPICAL; SUPPOSITORY
`VAGINAL; EMULSION, CREAM
`VAGINAL; OINTMENT
`VAGINAL; SUPPOSITORY
`BUTYLATED HYDROXYTOLUEHE
`INHALATION; LIQUID
`INTRAMUSCULAR;
`INJECTION
`IVCINFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`
`:
`
`ut
`
`600135193
`010043353
`
`000106978
`
`000075650
`008003245
`
`900128370
`
`PAGE 11
`
`etRRmRUTEO
`MRRONRODDDeOeRtee
`
`POTENCY RANGE
`
`0.05% - 2.0%
`0.6% - 1.0%
`
`APPROVAL
`DATE
`
`01/13/76
`
`04/02/63
`12/29/95
`12/28/82
`02/25/94
`
`DIV
`
`£00
`
`UNK
`600
`600
`600
`
`11/26/82
`
`08/08/85
`
`516
`
`f.0003%
`
`11/22/95
`
`150
`
`@.1MG - 0.2MG
`
`10/31791
`
`08/31/92
`04/16/81
`12/23/62
`09/30/83
`04/26/93
`01704795
`USG/26/95
`
`600
`euu
`600
`UNK
`UNK
`520
`4nn
`
`520
`
`0.04MG - 1.5MG
`
`u.,augcome - 2.2136
`0.56
`0.0052%
`0.005% - 0.02%
`
`© ONt7% - 0,00464%
`1.0mMG
`
`08/08/85
`
`510
`
`0.001%
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 16
`
`

`

`
`
`NReeLOReNUReeeoeHmNNReSeete
`
`uw
`
`APPROVAL
`DATE
`
`AR/IT/7TR
`
`12/11/87
`UBL SIs FZ
`Liseusyed
`10/05/78
`06/15/77
`05/04/77
`
`510
`
`£006
`ouuU
`
`UNK
`
`UNK
`UNK
`
`POTENCY RANGE
`
`?MR
`ff
`f GTAMG -
`O.IMG - 9.6mG
`Se
`
`-ULCSMG - UZ SMG
`-uZz - 0.1%
`05%
`02%
`MS%
`
`QepPpac
`
`12/20/95
`02/14/94
`
`520
`$00
`
`UI/LS/ 74
`
`520
`
`0.00582
`
`09/17/69
`03/31/81
`11/14/94
`vay eos yy
`12/17/81
`12/23/83
`
`120
`UNK
`UNK
`SUL
`600
`600
`
`Sap
`aoc
`
`-CO2ZBMG ~ 0.004MG
`-O06MG
`-N6MG
`
`-£4 - 0.4%
`-02%
`»18% - 0.3%
`
`04/12/88
`02/09/89
`09/28/92
`
`600
`600
`600
`
`&.0MG - 6.3HG
`B.3MG - 10.0MG
`
`12/31/93
`
`510
`
`125,684G - 224.7MG
`
`04/16/91
`
`600
`
`4.17MG - 60.0MG
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS R
`A
`ND
`LAST
`COUNT
`NDA
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`BUTYLATED HYDROXYTOLUENE
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; EMULSION, CREAM
`TOPICAL; GEL
`TOPICAL; OINTMENT
`TOPICAL; SOLUTION
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BUTYLENE GLYCOL
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`BUTYLPARABEN
`INTRAMUSCULAR;
`INJECTION
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`DRAL; DROPS
`QRAL; SOLUTION
`ORAL; SUSPENSION
`$s
`3
`SYRUP
`ORAL; TABLET
`DRAL; TABLET, COATED
`ORAL; TABLET, REPEAT ACTION
`ORAL; TABLET, SUSTAINED ACTION
`RECTAL; SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTIGN
`TOPICAL; OINTMENT
`CAFFEINE
`OPHTHALMIC; SOLUTIGN
`CALCIUM
`INJECTION
`IM - IV;
`TNTRAMUSCULAR 5
`INJECTION
`caLcrun ACETATE
`ORAL-21; TABLET
`ORAL-28; TABLET
`TOPICAL; EMULSION, CREAM
`CALCIUM ASCORBATE
`ORAL; SUSPENSION
`CALCIUM CARBONATE: PRECIPITATED
`ORAL; CAPSUL
`ORAL; CAPSULE, HARD GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`
`000128376
`
`000107860
`
`000094268
`
`900058082
`007440702
`
`O00062544
`
`005743271
`
`000471342
`
`PAGE 12
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 17
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG. PRODUCTS
`CAS #
`NDA
`LAST
`COUNT
`NDA
`
`CALCIUM CARBONATE, PRECIPITATED
`ORAL; TABLET, COATED
`TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL;
`FILM COATED
`ORAL; TABLET,
`SUSTAINED ACTION
`ORAL; TABLET,
`ORAL-21; TABLET
`ORAL-28; TABLET
`OTIC; SOLUTION
`CALCIUM CHLORIDE
`INJECTION
`CAUDAL BLOCK;
`EPIDURAL;
`INJECTION
`IM -
`IV;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAOCULAR; SOLUTION
`INTRAPERITONEAL; SOLUTION
`HERVE BLOCK;
`INJECTION
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`ORAL; CONCENTRATE
`ORAL; SUSPENSION
`SUBCUTANEOUS;
`INJECTION
`CALCIUM GLUCEPTATE
`INTRAVENOUS;
`INJECTION
`CALCIUM HYDROXIDE
`GRAL; SUSPENSION
`TOPICAL; EMULSION, CREAM
`CALCIUM LACTATE
`VAGINAL; TABLET
`CALCIUM PHOSPHATE
`ORAL; CAPSULE
`GRAL; TABLET
`COATED
`ORAL; TABLET,
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, REPEAT ACTION
`pRAL21; TAgLET
`ORAL~28; TABLET
`CALCIUM PHOSPHATE DIBASIC DIHYDRATE-SUCROSE AGGLOMERATE
`ET
`ORAL; TABL
`DIBASIC
`CALCIUM PHOSPHATE,
`AL; CAPSULE
`ORAL ;
`Be SUSTAINED ACTION
`PASTI
`ORAL;
`SYRUP.
`ORAL;
`TABLET
`ORAL ;
`3 TABLET CIMMED.5/COMP RELEASE), UNCOATED,
`TABLET, COATE
`3 TABLET, DELAYED ACTION, ENTERIC COATED
`j TABLET, DISPERSIBLE
`
`000471341
`
`910035048
`
`017140602
`001305620
`
`000814802
`
`910103465
`
`~
`
`007757939
`
`PAGE 13
`
`ite
`
`ERICUTERe0
`
`nN nNTedfetbedThBetbeAND,bedINSohada_
`
`beepet
`~
`
`N
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`82/2579?
`
`6n0
`
`0.72MG - 64.8MG
`
`08/19/91
`
`UNK
`
`87 .5MG - 229.74G
`
`B2/25/94
`
`600
`
`9,382%
`
`12/61/86
`D5/0? /BB
`
`U4/ 28/95
`12/1/60
`09/22/93
`04/27/83
`
`600
`#0
`
`600
`BUU
`
`690
`
`-033%
`nner
`
`20
`0.04R%
`
`u.uéds% - 9.033%
`0.008%
`
`11/18/93
`01/15/70
`OR/15/7R
`
`12/30/81
`12/30/81
`
`04/10/84
`04/18/62
`
`11/30/95
`hes dusbe
`
`UTeeyee200
`1
`ww raw ao
`
`600
`120
`
`ann
`Guu
`
`21.5MG
`§&1 SMB
`
`- 160.6MG
`- 362.0MG
`82.9MG - B6.0mG
`B6.0MG
`2
`
`1.84G - 2.4MG
`§.0MG - 234.04MG
`
`f nzimMe - 250,0MG
`35.0MG - 168.0MG
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2025 Page 18
`
`

`

` INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`4
`2
`2
`4
`1
`
`\
`‘
`\
`s
`.
`4
`
`5
`4
`
`12/12/95
`08/21/92
`04/12/88
`g2/09/89
`
`120
`UNK
`600
`600
`
`101.48MG - 136.25MG
`40.531MG
`4GO.531MG - 104.5MG6
`
`09/29/55
`10/03/77
`12/29/92
`
`600
`600
`120
`
`5.55MG - 378.78MG
`73.3MG - 219.9MG
`26.7MG - 366.3MG
`
`11/24/93
`01/26/84
`
`Us715/B/
`
`UNK
`510
`
` UNK
`
`9.26MG - 284.0MG
`14.GMG - 21.0MG
`
`Luu. UMG
`
`03/22/78
`
`600
`
`128.52MG - 298.04MG
`
`03/23/87
`12/26/90
`03/16/89
`09/29/95
`06/28/89
`04/28/95
`10/22/85
`02/23/78
`
`600
`150
`600
`600
`600
`600
`600
`600
`
`4.0MG - 15.0MG
`9.114MG - 21.1MG
`7.93MG - 91.9MG
`8.23MG - 21.0MG
`15.0MG - 47.5MG
`4.6MG - 10.0MG
`10.0MG - 20.0MG
`2.0MG
`
`180
`10/15/84
`QA/O7/7K 179M
`u2/is/B9 600
`08/16/85
`120
`12/30/83
`110
`03/31/81
`UNK
`11/14/94
`UNK
`11/17/95
`510
`11/21/74
`160
`05/24/82
`600
`01/04/82
`600
`
`50.0MG - 74.648MG
`A 53MG ~ 1.54MG
`9.038MG - 307.46MG
`4.532MG - 170,0MG
`221.0MG - 443,0MG
`235.0MG
`340.0MG
`10.7MG
`2.6MG - 370.0MG
`17.45MG - 279.309MG
`12.36MG - 214,24HG
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CALCIUM PHOSPHATE, DIBASIC
`ORAL; TABLET, FILM CGATED
`ORAL; TABLET, SUSTAINED ACTION
`DRAL-21; TABLET
`ORAL-28; TABLET
`TOPICAL; SHAMPOO
`CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`CALCIUM PHOSPHATE, TRIBASIC
`ORAL; CAPSULE, SUSTAINED ACT