Is Adrenalin still available?

Yes. Adrenalin (NDA 215875) is listed with marketing status Prescription in the FDA Orange Book.

Does Adrenalin have a generic?

Yes. The Orange Book lists 11 approved generic (ANDA) applications sharing Adrenalin's active ingredient (Epinephrine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Adrenalin's patents expire?

The FDA Orange Book lists 4 patents against Adrenalin, with the last listed patent expiring Mar 21, 2039. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Adrenalin's FDA application number?

Adrenalin is approved under NDA 215875, held by Ph Health.

Orange Book product · Brand (NDA)

Adrenalin

Epinephrine

Brand (NDA)NDA 215875RLD Ph Health

Approved

Apr 21, 2023

Application

Brand (NDA)

TE code

Not listed

Listed patents

Adrenalin (Epinephrine) is Ph Health's brand-name drug, approved by the FDA under NDA 215875 in 2023. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 11 approved generics share this drug's active ingredient. The FDA Orange Book lists 4 patents against it, the last expiring 2039.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Apr 21, 2023
3 yr 3 mo ago
Today
Patent 10653646 expires
Listed drug product patent expiration.
Mar 21, 2039
in 12 yr 11 mo
Patent 11083698 expires
Listed method-of-use patent (U-3567) expiration.
Mar 21, 2039
in 12 yr 11 mo
Patent 11207280 expires
Listed drug product patent expiration.
Mar 21, 2039
in 12 yr 11 mo
Patent 12133837 expires
Listed drug product patent expiration.
Mar 21, 2039
in 12 yr 11 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

EPINEPHRINE

Strength

5MG/250ML (20MCG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215875

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 215875

Brand + generics

Active-ingredient family

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

View full Epinephrine family

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10653646	Mar 21, 2039	in 12 yr 11 mo	Product
11083698	Mar 21, 2039	in 12 yr 11 mo	U-3567
11207280	Mar 21, 2039	in 12 yr 11 mo	Product
12133837	Mar 21, 2039	in 12 yr 11 mo	Product

Adrenalin — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Epinephrine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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