`
`Entry
`No.
`
`Drug Name
`
`Formulation
`Type
`
`Scale
`Propyl Paraben
`
`Methyl
`Paraben
`
`1
`
`2
`
`3
`
`4
`
`51
`
`6
`
`B-Complex Vitamin
`Veterinary
`Calamine Cream
`
`Injection
`
`1.169 (mg/mL)
`
`0.134 (mg/mL)
`
`Cream
`
`1.80 (mg/g)
`
`0.20 (mg/g)
`
`Cefadroxil
`Dispersible Tablets
`(250 mg)
`
`Cetirizine
`Hydrochloride Syrup
`
`Chlophedianol,
`Ipecac, Ephedrine,
`Ammonium Chloride,
`Carbnoxamine, and
`Balsam Tolu Syrup
`Cisapride Suspension
`
`Tablet
`
`0.45 (mg/tablet)
`
`0.05
`(mg/tablet)
`
`Syrup
`
`Syrup
`
`4.50 (mg/5 mL)
`or
`0.9 (mg/mL)
`0.9 (mg/tablet)
`
`0.50 (mg/5 mL)
`or
`0.1 (mg/mL)
`0.1 (mg/tablet)
`
`0.9 (mg/mL)
`
`0.1 (mg/mL)
`
`Suspension
`
`9.00 (mg/5 mL)
`or
`1.80 (mg/mL)
`
`1.00 (mg/5 mL)
`or
`0.20 (mg/mL)
`
`Ratio of
`Methyl
`Paraben:
`Propyl
`Paraben
`8.72:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`Volume(s) Page(s)
`
`Total
`Parabens
`(mg/mL)
`
`1.303
`
`N/A
`
`N/A
`
`1.00
`
`1.00
`
`2.00
`
`6
`
`4
`
`5
`
`1
`
`3
`
`3
`
`5
`
`3
`
`106-107
`
`127
`
`121
`
`72
`
`99
`
`100
`
`131
`
`105
`
`1 Entries present in Liquid and OTC products volumes. Entries and related discussion indicate that it is a liquid.
`EXHIBIT
`lo?l
`
`Apotex (IPR2019-00400) Ex. 1031 p. 001
`
`
`
`Safaraz K. Niazi, Handbook of Pharmaceutical Manufacturing Formulations, 1st Ed., Vols. 1-6
`
`Entry
`No.
`
`Drug Name
`
`Formulation
`Type
`
`Scale
`Propyl Paraben
`
`Methyl
`Paraben
`
`Volume(s) Page(s)
`
`Total
`Parabens
`(mg/mL)
`
`Ratio of
`Methyl
`Paraben:
`Propyl
`Paraben
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`6
`
`6
`
`6
`
`6
`
`6
`
`3
`
`6
`
`6
`
`3
`
`5
`
`150-151
`
`160
`
`161
`
`200
`
`203
`
`127
`
`207-208
`
`219
`
`137
`
`157
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`Cyancobalamin,
`Pyridoxine, and
`Thiamine Injection
`Dexamethasone
`Injection, Veterinary
`Dexamethasone
`Sodium Phosphate
`Injection
`Exemestane Aqueous
`Suspension Injection
`Flumazenil Injection
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`0.18 (%/mL) or
`1.80 mg/mL
`
`Injection
`
`1.80 (mg/mL)
`
`0.02 (%/mL)
`Or
`0.20 mg/mL
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Furosemide Syrup
`
`Syrup
`
`Gentamicin Injection
`(80mg/2 mL)
`
`Injection
`
`9.00 (mg/5 mL)
`or
`1.80 (mg/mL)
`1.80 (mg/mL)
`
`1.00 (mg/5 mL)
`or
`0.20 (mg/mL)
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Hydromorphone
`Hydrochloride
`Injection
`(Multiple Dose)
`Iron Polystyrene and
`Vitamin C Syrup
`
`Syrup
`
`1.40 (mg/mL)
`
`0.16 (mg/mL)
`
`8.75:1
`
`1.56
`
`Apotex (IPR2019-00400) Ex. 1031 p. 002
`
`
`
`Safaraz K. Niazi, Handbook of Pharmaceutical Manufacturing Formulations, 1st Ed., Vols. 1-6
`
`Entry
`No.
`
`Drug Name
`
`Formulation
`Type
`
`Scale
`Propyl Paraben
`
`Methyl
`Paraben
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Isometheptene
`Hydrochloride
`Veterinary Injection
`Levorphanol
`Tartarate Injection
`
`Magaldrate with
`Simethicone
`Suspension
`Mebendazole
`Suspension
`Medroxyprogesterone
`Acetate Sterile
`Aqueous Suspension
`Medroxyprogesterone
`and Estradiol Sterile
`Suspension
`Nalbuphine
`Hydrochloride
`
`Naloxone
`Hydrochloride
`Injection 1 mg/mL
`Naloxone
`Hydrochloride
`Injection 0.04 mg/mL
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Suspension
`
`Suspension
`
`9.00 (mg/5 mL)
`or
`1.80 (mg/mL)
`1.80 (mg/mL)
`
`1.00 (mg/5 mL)
`or
`0.20 (mg/mL)
`0.20 (mg/mL)
`
`Suspension
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Suspension
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Ratio of
`Methyl
`Paraben:
`Propyl
`Paraben
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`Volume(s) Page(s)
`
`Total
`Parabens
`(mg/mL)
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`6
`
`6
`
`3
`5
`
`3
`
`6
`
`6
`
`6
`
`6
`
`6
`
`234
`
`241,
`243
`
`145
`167
`
`147
`
`248-249
`
`249
`
`263
`
`263-264
`
`263-264
`
`Apotex (IPR2019-00400) Ex. 1031 p. 003
`
`
`
`Safaraz K. Niazi, Handbook of Pharmaceutical Manufacturing Formulations, 1st Ed., Vols. 1-6
`
`Entry
`No.
`
`Drug Name
`
`Formulation
`Type
`
`Scale
`Propyl Paraben
`
`Methyl
`Paraben
`
`Ratio of
`Methyl
`Paraben:
`Propyl
`Paraben
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`9:1
`
`Volume(s) Page(s)
`
`Total
`Parabens
`(mg/mL)
`
`2.00
`
`2.00
`
`2.00
`
`2.00
`
`1.20
`
`N/A
`
`1.00
`
`0.856
`
`0.189
`
`6
`
`3
`
`6
`
`6
`
`3
`
`4
`
`6
`
`3
`
`3
`5
`
`270-271
`
`162
`
`279
`
`286
`
`168
`
`228
`
`321
`
`200
`
`215-216
`273
`
`25
`
`26
`
`27
`
`28
`
`29
`
`30
`
`31
`
`32
`
`33
`
`Neostigmine
`Methylsulfate
`Injection Single-Dose
`Vial
`Nystatin Oral
`Suspension
`Oxymorphone
`Hydrochloride
`Injection
`Pentylenetetrazole
`Injection
`Pheniramine Maleate
`Syrup
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Suspension
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Injection
`
`1.80 (mg/mL)
`
`0.20 (mg/mL)
`
`Syrup
`
`5.40 (mg/5 mL)
`or
`1.08 (mg/mL)
`1.80 (mg/g)
`
`0.60 (mg/5 mL)
`or
`0.12 (mg/mL)
`0.20 (mg/g)
`
`Pramoxine Cream
`
`Cream
`
`Succinylcholine
`Chloride Injection
`Tolu Balsam Cough
`Syrup
`
`Vitamin B-Complex
`and Iron Syrup
`
`Injection
`
`0.90 (mg/mL)
`
`0.10 (mg/mL)
`
`Syrup
`
`0.77 (mg/mL)
`
`0.086 (mg/mL)
`
`Syrup
`
`0.170 (mg/mL)
`
`0.019 (mg/mL)
`
`Apotex (IPR2019-00400) Ex. 1031 p. 004
`
`