Epinephrine Generic: When Will Generic Epinephrine Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Epinephrine Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? March 2039 About 12.5 years away Why then?
  2. Has the FDA approved a generic? July 2018 7 companies approved
  3. When does the brand’s protection end? January 2045 Its one listed patent Why sooner?
  4. Can you buy a generic today? Yes 11 companies list one

Explains

PharmD, BCPS · Clinical pharmacist

It already is. A generic epinephrine is listed for sale by 11 companies, so ask your pharmacy whether it can fill your prescription with one.

Why March 2039?

A patent that protects the brand runs out. After that, approved generics can be sold. We rate it toss-up: still unsettled. Just as likely to slip as to hold.

If Epinephrine’s protection runs to January 2045, how can a generic come sooner?

The patent that runs to January 2045 (12,539,283) covers the product’s formulation. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Generic companies have been challenging Epinephrine’s patents with the FDA since August 2020. That is why the expected month comes before the last protection ends. See the road to a generic

What should I do now?

Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Epinephrine, but the active ingredient, strength and form are the same. What a generic means for you

Our month is only an estimate based on available information, so we never name a day.

Epinephrine by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Toss-up Still unsettled. Just as likely to slip as to hold.
Price competition
None filed yet No filers on record
Brand sales
$15M a yearSmaller seller
  • FDA approved 2014 July 2014 FDA Orange Book
  • Patents listed 1 last runs to January 2045 FDA Orange Book
  • Generics FDA-approved 7 companies, the first approved July 2018 FDA Orange Book
  • Pharmacies pay $1.24 per mL NADAC, October 2026
  • Medicare Part D spent $128.4M in 2025, for 476.8K people CMS Part D Spending by Drug
  • Medicaid prescriptions 1,064 in the last four reported quarters, $59.1K CMS Medicaid drug utilization, to Q1 2026

Epinephrine’s Road to a Generic

Epinephrine has had the market to itself since the FDA approved it in July 2014 (Baxter Healthcare Corp). Its one listed patent runs to January 2045. Generic companies have challenged its patents with the FDA since August 2020.

The first generic of Epinephrine is expected in March 2039.

Why that month: a patent that protects the brand runs out. After that, approved generics can be sold. That is about 6 years before the last listed patent runs out, in January 2045.

Brand alone on the market Since FDA approval, July 2014
Patent 12,539,283 Expires January 2045
Brand alone on the market Patent on the formulation First generic expected Swipe the chart sideways to see every year.

Why a Generic Can Come Before January 2045

The last listed patent runs to January 2045, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Epinephrine Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Epinephrine’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

Patents listed with the FDA (1)
PatentWhat it coversProtects untilStatus
12,539,283 The product’s formulation January 2045 Active

Source: FDA Orange Book, application 220626, 205029, 215425, 209359, 211363. Patent numbers open the patent on Google Patents.

Patent Challenges to Epinephrine

The first patent challenge to Epinephrine reached the FDA in August 2020, from one company on that first day. A first challenger began selling its generic in December 2024.

What Is a Patent Challenge?

A generic company that wants to sell its version before Epinephrine’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.

Patent challenges on the FDA’s list (1)
ProductFirst challengedCompanies that day180-day head startFirst challenger’s genericChallenged patents run to
ApprovedOn sale
Injection, 1 mg/mL August 2020 1 company Head start still held decided March 2025 Earlier: decision deferred, November 2024 November 2024 December 2024 August 2034

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Epinephrine

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

1

Applied to the FDA

No application count is on record for Epinephrine, but the FDA has already approved 7 companies (step 2), and every approval starts with an application.

The FDA has tentatively approved one company’s generic: Hospira Inc (March 2021). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.

Generic companies have challenged Epinephrine’s patents with the FDA since August 2020: see the patent challenges.

2

Approved by the FDA

The FDA has approved generic versions from 7 companies, the first in July 2018. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

3

For Sale in Pharmacies

Yes. A generic epinephrine is listed for sale by 11 companies. Ask your pharmacy whether it can fill your prescription with it.

American Regent, Inc., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals Private Limited, CIVICA, INC., Fresenius Kabi USA, LLC, Gland Pharma Limited and 5 more

Generic versions the FDA has approved (7 companies)
CompanyFirst approvedStrengthsRated
American Regent Inc July 2018EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 30MG BASE/30ML (EQ 1MG BASE/ML)AP
International Medication Systems Ltd April 2020EQ 30MG BASE/30ML (EQ 1MG BASE/ML)AP
Fresenius Kabi USA LLC November 20241MG/ML (1MG/ML)AP
Gland Pharma Ltd February 20251MG/ML (1MG/ML), 10MG/10ML (1MG/ML), 30MG/30ML (1MG/ML)AP
Amneal Eu Ltd October 2025EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 30MG BASE/30ML (EQ 1MG BASE/ML)AP
Hikma Pharmaceuticals USA Inc May 20261MG/ML (1MG/ML)AP
Deva Holding Anonim Sirketi July 20261MG/ML (1MG/ML)AP

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Epinephrine Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Epinephrine 1 mg/10 mL luerjet

$1.24 per mL in October 2026.

Hover over or tap anywhere on the chart to see that month’s price.

  • Epinephrine 1 mg/10 mL abbojct $1.19 per mL
  • Epinephrine 1 mg/10 mL luerjet $1.24 per mL
See the numbers
MonthPharmacies paid per mL
October 2026$1.24
September 2026$1.24
August 2026$1.23
July 2026$1.21
June 2026$1.20
May 2026$1.19
April 2026$1.19
March 2026$1.20
February 2026$1.19
January 2026$1.19

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

How we estimate it. We start from what pharmacies pay for Epinephrine today: $1.24 per mL for Epinephrine 1 mg/10 mL luerjet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).

Dollar figures apply FDA’s median drops to the $1.24 pharmacies pay per mL today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.

What Medicare and Medicaid Spend on Epinephrine

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicare Part D Spending

What Medicare drug plans spent on Epinephrine, before manufacturer rebates.

$29M
January to March 2026, the latest CMS has posted
For 110,810 people, about $241 per prescription fill
$128.4M
2025, the whole year
For 476,802 people, about $213 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$29,005,001110,810$240.69
2025$128,371,724476,802$212.62

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Epinephrine only, so no generic is counted in it. What CMS says it is used for: This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine works quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

Medicaid Prescriptions by Quarter

1,064 prescriptions in the four quarters to Q1 2026, $59.1K paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 20260$0
Q4 2025320$14,369
Q3 2025370$20,412
Q2 2025374$24,302
Q1 2025410$37,320

Source: CMS Medicaid State Drug Utilization Data, over Epinephrine’s own package codes.

Epinephrine Strengths and Forms

StrengthFormHow it is takenApprovedStatus
1MG/ML (1MG/ML)SolutionIntravenous, intraocular, intramuscular, subcutaneousJuly 2014Prescription reference product
10MG/10ML (1MG/ML)SolutionIntramuscular, intravenous, subcutaneousFebruary 2022Prescription reference product
1MG/ML (1MG/ML)SolutionIntramuscular, intravenous, subcutaneousMarch 2026Prescription reference product
30MG/30ML (1MG/ML)SolutionIntramuscular, intravenous, subcutaneousMarch 2026Prescription reference product
1MG/10ML (0.1MG/ML)SolutionIntravenousNovember 2019Discontinued reference product
1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SolutionIntravenousMay 2023Discontinued reference product

Source: FDA Orange Book, Baxter Healthcare Corp. Listed for sale today by Henry Schein, Inc., Hospira, Inc., A-S Medication Solutions, HF Acquisition Co LLC, DBA HealthFirst and 11 more (FDA NDC Directory).

Epinephrine NDC Codes and Packages

Each Epinephrine package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Epinephrine packages (52)
NDCProductPackageCompany
00409-4933-010.1 mg/mL injection, solutionpackage of 10 cartons of 1 syringe of 10 mLHospira, Inc.
62250-0102-011 mg/mL injectionvial of 10 mLBelcher Pharmaceuticals, LLC
52584-0103-011 mg/mL injection, solution, concentrateampule of 1 mLGeneral Injectables and Vaccines, Inc.
70518-1215-001 mg/mL injection, solution, concentratebox of 10 ampules of 1 mLRemedyrepack Inc.
00404-9806-10EPINEPHRINE .1 mg/mL injectionsyringe of 10 mLHenry Schein, Inc.
50090-7037-00EPINEPHRINE .1 mg/mL injectioncarton of 1 mLA-S Medication Solutions
50090-7037-01EPINEPHRINE .1 mg/mL injectionpackage of 10 cartons of 1 mLA-S Medication Solutions
51662-1629-01EPINEPHRINE .1 mg/mL injectionsyringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
Show the other 44 Epinephrine packages
NDCProductPackageCompany
51662-1629-01EPINEPHRINE .1 mg/mL injectionsyringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
51662-1629-03EPINEPHRINE .1 mg/mL injectioncase of 10 pouches of 1 box of 1 syringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
51662-1629-03EPINEPHRINE .1 mg/mL injectioncase of 10 pouches of 1 box of 1 syringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
70518-3816-00EPINEPHRINE .1 mg/mL injectionpackage of 10 cartons of 1 syringe of 10 mLRemedyrepack Inc.
70518-3816-00EPINEPHRINE .1 mg/mL injectionpackage of 10 cartons of 1 syringe of 10 mLRemedyrepack Inc.
71872-7304-01EPINEPHRINE .1 mg/mL injectionsyringe of 10 mLMedical Purchasing Solutions, LLC
71872-7304-01EPINEPHRINE .1 mg/mL injectionsyringe of 10 mLMedical Purchasing Solutions, LLC
76329-3318-01EPINEPHRINE .1 mg/mL injectionpackage of 10 cartons of 1 syringe of 10 mLInternational Medication Systems, Limited
76329-3318-01EPINEPHRINE .1 mg/mL injectionpackage of 10 cartons of 1 syringe of 10 mLInternational Medication Systems, Limited
84549-0018-01EPINEPHRINE .1 mg/mL injectionsyringe of 10 mLProPharma Distribution
51662-1531-01EPINEPHRINE .1 mg/mL injection, solutionsyringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
51662-1531-01EPINEPHRINE .1 mg/mL injection, solutionsyringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
51662-1531-03EPINEPHRINE .1 mg/mL injection, solutioncarton of 50 pouches of 1 carton of 1 syringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
51662-1531-03EPINEPHRINE .1 mg/mL injection, solutioncarton of 50 pouches of 1 carton of 1 syringe of 10 mLHF Acquisition Co LLC, DBA HealthFirst
71872-7250-01EPINEPHRINE .1 mg/mL injection, solutionsyringe of 10 mLMedical Purchasing Solutions, LLC
71872-7250-01EPINEPHRINE .1 mg/mL injection, solutionsyringe of 10 mLMedical Purchasing Solutions, LLC
51662-1706-01EPINEPHRINE 1 mg/mL injectionvial of 1 mLHF Acquisition Co LLC, DBA HealthFirst
51662-1706-03EPINEPHRINE 1 mg/mL injectionbox of 25 pouches of 1 vial of 1 mLHF Acquisition Co LLC, DBA HealthFirst
54288-0117-10EPINEPHRINE 1 mg/mL injectioncarton of 10 syringes of 1 mLBPI Labs, LLC
54288-0117-10EPINEPHRINE 1 mg/mL injectioncarton of 10 syringes of 1 mLBPI Labs, LLC
54288-0119-10EPINEPHRINE 1 mg/mL injectioncarton of 10 vials of 1 mLBPI Labs, LLC
54288-0119-25EPINEPHRINE 1 mg/mL injectioncarton of 25 vials of 1 mLBPI Labs, LLC
54288-0120-01EPINEPHRINE 1 mg/mL injectionvial of 10 mLBPI Labs, LLC
54288-0120-01EPINEPHRINE 1 mg/mL injectionvial of 10 mLBPI Labs, LLC
54288-0600-01EPINEPHRINE 1 mg/mL injectionvial of 10 mLBPI Labs, LLC
54288-0600-01EPINEPHRINE 1 mg/mL injectionvial of 10 mLBPI Labs, LLC
70518-4156-00EPINEPHRINE 1 mg/mL injectioncarton of 25 vials of 1 mLRemedyrepack Inc.
71872-7360-01EPINEPHRINE 1 mg/mL injectionvial of 1 mLMedical Purchasing Solutions, LLC.
00404-9857-01EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLHenry Schein, Inc.
00404-9857-01EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLHenry Schein, Inc.
43066-0801-02EPINEPHRINE 1 mg/mL injection, solution, concentratevial of 30 mLBaxter Healthcare Corporation
43066-0803-25EPINEPHRINE 1 mg/mL injection, solution, concentratecarton of 25 vials of 1 mLBaxter Healthcare Corporation
50090-3039-00EPINEPHRINE 1 mg/mL injection, solution, concentratebox of 25 ampules of 1 mLA-S Medication Solutions
50090-3039-01EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLA-S Medication Solutions
50090-3039-01EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLA-S Medication Solutions
50090-3039-02EPINEPHRINE 1 mg/mL injection, solution, concentratebox of 10 ampules of 1 mLA-S Medication Solutions
54288-0103-10EPINEPHRINE 1 mg/mL injection, solution, concentratebox of 10 ampules of 1 mLBPI Labs, LLC
54288-0103-10EPINEPHRINE 1 mg/mL injection, solution, concentratebox of 10 ampules of 1 mLBPI Labs, LLC
63323-0698-30EPINEPHRINE 1 mg/mL injection, solution, concentratevial of 30 mLFresenius Kabi USA, LLC
71872-7117-01EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLMedical Purchasing Solutions, LLC
71872-7117-01EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLMedical Purchasing Solutions, LLC
72572-0238-01EPINEPHRINE 1 mg/mL injection, solution, concentratevial of 30 mLCivica, Inc.
84549-0103-10EPINEPHRINE 1 mg/mL injection, solution, concentrateampule of 1 mLProPharma Distribution
54288-0152-01EPINEPHRINE 30 mg/30mL injectionvial of 30 mLBPI Labs, LLC

Source: the FDA NDC Directory, current listings only. Only packages sold under Epinephrine’s own FDA approval (NDA 220626, NDA 205029, NDA 215425, NDA 209359, NDA 211363) are listed, never a generic. Some codes belong to companies that repackage Epinephrine: it is the same medicine in a different package.

What a Generic Epinephrine Means for You

Nothing Changes Until It Is in Pharmacies

A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.

Your Pharmacy May Switch You Automatically

Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.

It Will Probably Look Different

US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.

Your Insurance May Change Too

Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.

Questions people ask about Epinephrine

Is there a generic for Epinephrine right now?

Yes. The FDA NDC Directory lists a generic epinephrine from 11 companies. Ask your pharmacy whether it can fill your prescription with it.

When will Epinephrine go generic?

It already has. The FDA NDC Directory lists a generic epinephrine from 11 companies, so ask your pharmacy whether it can fill your prescription with one.

Will generic epinephrine be the same as Epinephrine?

Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.

How much will the generic cost?

Nobody can say for sure before launch. The FDA has already approved 7 companies to make a generic, and how many of them launch decides how far the price falls.

Has the FDA approved a generic Epinephrine?

Yes. The FDA Orange Book lists approved generic versions from 7 companies, the first approved in July 2018: American Regent Inc, International Medication Systems Ltd, Fresenius Kabi USA LLC, Gland Pharma Ltd and 3 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

When does the Epinephrine patent expire?

One patent is listed for Epinephrine in the FDA Orange Book; it runs to January 2045. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (March 2039) weighs all of that.

Has anyone challenged the Epinephrine patents?

Yes. The first patent challenge to Epinephrine reached the FDA in August 2020, from one company on that first day. A first challenger began selling its generic in December 2024. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.

How much does Epinephrine cost now?

Pharmacies paid about $1.24 per mL for Epinephrine 1 mg/10 mL luerjet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected March 2039 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.

Also Going Generic

All upcoming generics

About Epinephrine

Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.