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Orange Book product · Brand (NDA)

REZENOPY

NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 215487RX SCIENTURE
View NALOXONE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Apr 19, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 19, 2024

    2 yr 2 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Apr 19, 2027

    in 10 mo

  4. Patent 12514854 expires

    Listed method-of-use patent (U-4397) expiration.

    Feb 05, 2041

    in 14 yr 10 mo

  5. Patent 12622903 expires

    Listed drug product patent expiration.

    Feb 05, 2041

    in 14 yr 10 mo

Pharmaceutical detail

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

10MG/SPRAY

Dosage form

SPRAY

Route

NASAL

TE code

Not listed

Application

NDA 215487

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Apr 19, 2027

    in 10 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12514854Feb 05, 2041in 14 yr 10 mo
U-4397
12622903Feb 05, 2041in 14 yr 10 mo
Product
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