`
`Injectable (and intranasal-
`IN) generic
`
`Intranasal branded
`
`Injectable generic1
`
`Auto-injector branded
`
`Brand name
`
`Narcan Nasal Spray
`
`Evzio Auto-Injector
`
`Product comparison
`
`(Product not yet
`released2)
`
`FDA approved
`Labeling includes instructions
`for layperson use
`
`X (for IV, IM, SC)
`
`X
`X
`
`Assembly required
`
`Fragile
`
`Can titrate dose
`
`Strength
`
`X
`
`X
`
`X
`
`(yellow & purple)
`
`(blue & purple)
`
`(Formulation to
`be discontinued3)
`
`X
`X
`
`X
`
`X
`
`X
`
`1 mg/mL
`
`4 mg/0.1 mL
`
`2mg/0.1mL
`
`0.4 mg/mL
`
`4 mg/10 mL
`
`0.4 mg/0.4mL
`
`2 mg/0.4mL
`
`Storage requirements
`(All protect from light)
`
`Store at 59-86 °F
`Fragile: Glass.
`
`Store at 59-77 °F
`Excursions from 39-104 °F
`
`Store at 68-77 °F
`Breakable: Glass.
`
`Store at 59-77 °F
`Excursions from 39-104 °F
`
`Cost/kit4
`
`Refills
`
`Rx and quantity
`
`$$
`
`Two
`
`$$
`
`Prescription variation
`
`Two
`
`$
`
`Two
`
`$$$
`
`Two
`
`#2 2 mL Luer-Jet™ Luer-Lock
`needleless syringe plus #2
`mucosal atomizer devices
`(MAD-300)
`
`#1 two-pack
`of two 4
`mg/0.1 mL
`intranasal
`devices
`
`#1 four-pack
`of four 2
`mg/0.1 mL
`intranasal
`devices
`
`#2 single-use 1 mL
`vials PLUS #2 3 mL
`syringe w/ 23-25
`gauge 1-1.5 inch
`IM needles
`
`#1 10mL multidose
`vial PLUS #2 3 mL
`syringe w/ 23-25
`gauge 1-1.5 inch IM
`needles
`
`#1 two-pack of
`two 0.4 mg/0.4
`mL prefilled
`auto-injector
`devices
`
`#1 two-pack of
`two 2 mg/0.4 mL
`prefilled auto-
`injector devices
`
`PrescribeToPrevent.org
`
`April 2017
`
`Opiant Exhibit 2117
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 1
`
`
`
`Naloxone Product Comparison
`
`
`Injectable (and intranasal-
`IN) generic
`
`Intranasal branded
`
`Injectable generic1
`
`Auto-injector branded
`
`Sig. (for suspected opioid
`overdose)
`
`Spray 1 ml (1/2 of syringe)
`into each nostril. Repeat after
`2-3 minutes if no or minimal
`response.
`
`Spray 0.1 mL into one nostril.
`Repeat with second device
`into other nostril after 2-3
`minutes if no or minimal
`response.
`
`Inject 1 mL in shoulder or thigh. Repeat
`after 2-3 minutes if no or minimal
`response.
`
`Inject into outer thigh as directed
`by English voice-prompt system.
`Place black side firmly on outer
`thigh and depress and hold for 5
`seconds. Repeat with second
`device in 2-3 minutes if no or
`minimal response.
`
`Ordering information
`
`How supplied
`
`Box of 10 Luer-Jet™ prefilled
`glass syringes
`
`Two-pack of single use
`intranasal devices
`
`Manufacturer
`
`
`IMS/ Amphastar
`
`Teleflex
`(off-label IN
`adapter)
`
`Adapt Pharma
`
`
`Web address
`
`Amphastar.com
`
`Teleflex. com
`
`Narcannasalspray.com
`
`Customer service
`
`800-423-4136
`
`866-246-6990
`
`844-462-7226
`
`NDC
`
`
`
`76329-3369-01 DME- no NDC
`
`69547-353-02
`
`
`69547-212-04
`
`Box of 10 or
`package of 25
`single-dose fliptop
`vials (1 ml)
`
`Pfizer, Mylan and
`West-Ward
`Pharmaceuticals
`
`Pfizerinjectables.com
`Mylan.com
`West-ward.com
`
`877-946-7747 (P)
`724-514-1800 (M)
`800-631-2174 (W)
`
`00409-1215-01 (P)
`67457-0292-02 (M)
`0641-6132-25 (W)
`
`Case of 25 multi-
`dose fliptop vials
`(10 ml)
`
`Two pack of single use auto-
`injectors + 1 trainer
`
`Pfizer
`
`kaléo
`
`
`Pfizerinjectables.com
`
`Evzio.com
`
`877-946-7747 (P)
`
`855-773-8946
`
`00409-1219-01
`
`60842-030-01
`
`60842-051-01
`
` 1
`
` Pfizer acquired Hospira in 2015. Pfizer has an additional naloxone product, which is not recommended for layperson and take-home naloxone use because it is complicated to assemble. (Naloxone Hydrochloride
`Injection, USP, 0.4 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) NDC# 0409-1782-69)
`2 This product concentration is not yet currently available. As a result, some of the content is left blank.
`3 EVZIO 2 mg is now available. As of February 2017, EVZIO 0.4 mg will no longer be manufactured, but is still currently available and effective.
`4 There is considerable price variance for each product- local pharmacists are able to provide specific local pricing.
`Image development supported by 1R01DA038082-01 Friedmann/Rich
`
`
`
`PrescribeToPrevent.org
`
`April 2017
`
`Opiant Exhibit 2117
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 2
`
`