You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 29, 2025

Epinephrine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for epinephrine and what is the scope of patent protection?

Epinephrine is the generic ingredient in thirty-four branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Viatris, Impax, Teva Pharms Usa, Endo Operations, Am Regent, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 3M, Baxter Hlthcare Corp, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical, Belmora Llc, Eastman Kodak, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Vyteris, Iomed, and Empi, and is included in sixty-seven NDAs. There are thirty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Epinephrine has two hundred and seventy-six patent family members in thirty-two countries.

There are twenty-one drug master file entries for epinephrine. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for epinephrine

See drug prices for epinephrine

Drug Sales Revenue Trends for epinephrine

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Montefiore Medical CenterN/A
University Hospital "Sestre Milosrdnice"N/A
Jessyka LighthallPhase 3

See all epinephrine clinical trials

Generic filers with tentative approvals for EPINEPHRINE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for FreeEQ 1MG BASE/ML (EQ 1MG BASE/ML)SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for EPINEPHRINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPINEPHRINE Injection epinephrine 1 mg/mL 205029 1 2020-08-13
ADRENALIN Injection epinephrine 30 mg/30 mL 204640 1 2018-08-20
ADRENALIN Injection epinephrine 1 mg/mL ampules 204200 1 2016-03-09
EPIPEN JR. Injection (Auto- injector) epinephrine 0.15 mg/0.3 mL and 0.3 mg/0.3 mL 019430 1 2009-07-20

US Patents and Regulatory Information for epinephrine

Showing 1 to 7 of 7 entries

Expired US Patents for epinephrine

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 5,665,071 ⤷  Try for Free
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 9,737,669 ⤷  Try for Free
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 8,361,029 ⤷  Try for Free
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 8,920,377 ⤷  Try for Free
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 10,335,549 ⤷  Try for Free
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 8,361,029 ⤷  Try for Free
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 9,737,669 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 7 of 7 entries

International Patents for epinephrine

CountryPatent NumberTitleEstimated Expiration
Australia 2019217643 Intranasal epinephrine formulations and methods for the treatment of disease ⤷  Try for Free
Australia 2016233682 ⤷  Try for Free
Canada 2978464 EPINEPHRINE FORMULATIONS ⤷  Try for Free
European Patent Office 1814611 DISPOSITIF D'ADMINISTRATION DE MEDICAMENTS (DEVICE FOR MEDICAMENT DELIVERY) ⤷  Try for Free
Morocco 50106 FORMULATIONS D'ÉPINÉPHRINE INTRANASALE ET MÉTHODES DE TRAITEMENT D'UNE MALADIE ⤷  Try for Free
South Korea 20180034307 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2007126851 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for epinephrine

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
3678649 122025000010 Germany ⤷  Try for Free PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649 301317 Netherlands ⤷  Try for Free PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649 C20250011 Finland ⤷  Try for Free
3678649 CA 2025 00007 Denmark ⤷  Try for Free PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649 PA2025507 Lithuania ⤷  Try for Free PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory for Epinephrine: Navigating a Critical Therapeutic Class

Last updated: July 27, 2025


Introduction

Epinephrine, also known as adrenaline, is a cornerstone in emergency medicine, primarily utilized for acute anaphylactic reactions, cardiac arrest, and local vasoconstriction. Recognized for its life-saving properties, epinephrine's market landscape is shaped by evolving regulatory frameworks, manufacturing complexities, patent considerations, and competition from biosimilars and alternative therapies. This report delineates the prevailing market dynamics and forecasts the financial trajectory for epinephrine, providing insights for stakeholders across the healthcare and pharmaceutical sectors.


Market Overview

Therapeutic Significance and Usage

Epinephrine's primary indications include emergency treatment of anaphylaxis, asthma exacerbations, and intraoperative vasoconstriction. The drug’s mechanism involves stimulating alpha and beta-adrenergic receptors, leading to bronchial dilation, increased cardiac output, and vasoconstriction. Its critical role in life-threatening situations sustains consistent demand, especially in emergency medical settings and pre-filled auto-injectors.

Global Market Size and Growth Drivers

The global epinephrine market was valued at approximately USD 1.2 billion in 2022. The compound annual growth rate (CAGR) is projected at 4-6% through 2030, driven by increasing prevalence of allergic conditions, expanding awareness, and regulatory mandates for epinephrine auto-injectors in schools and public spaces. The rising incidence of food allergies and allergic reactions, particularly among children, sustains high demand.

Geographical Market Distribution

North America dominates the market, accounting for over 50% of revenue, supported by advanced healthcare infrastructure, high allergy prevalence, and regulatory mandates. Europe follows, benefitting from rising allergy awareness and regulatory updates. Asia-Pacific shows the most promising growth potential due to expanding healthcare access, rising urbanization, and increasing allergy incidence, projected to grow at a CAGR exceeding 7% over the forecast period.


Market Dynamics Influencing the Epinephrine Sector

Regulatory Landscape and Patent Dynamics

Patent expiration for several branded epinephrine formulations, including EpiPen (Mylan, now part of Viatris), has catalyzed market entry of generic and biosimilar alternatives. The U.S. Food and Drug Administration (FDA) approved multiple generic epinephrine auto-injectors post-patent expiry, intensifying price competition and expanding accessibility. Regulatory frameworks favor biosimilar entry where demonstrated equivalence, but barriers persist due to device design complexities and patent litigation.

Manufacturing and Supply Chain Challenges

Epinephrine's stability and potency necessitate stringent manufacturing controls. The raw materials involve sensitive extraction and stabilization processes, leading to higher production costs and supply chain vulnerabilities. Recent recalls and shortages—exacerbated during events like the COVID-19 pandemic—underscore resilience issues, influencing market supply and pricing.

Pricing Trends and Market Competition

Market penetration of generics and biosimilars has led to significant downward pressure on prices. The price for a single auto-injector dose has declined by approximately 30-50% over the past five years. Nevertheless, high manufacturing costs and complex device technology sustain profit margins for key players. Cost-containment initiatives and policy pressures to improve affordability, especially in public healthcare systems, influence ongoing negotiations and pricing strategies.

Emerging Alternative Therapies

Research into novel anaphylaxis treatments, such as monoclonal antibody-based therapeutics and subcutaneous immunotherapy, pose potential future competition. While currently in early stages, these alternatives aim to mitigate reliance on epinephrine, potentially impacting market share.


Financial Trajectory and Forecasts

Revenue Trends and Growth Projections

The epinephrine market is expected to grow steadily, with a CAGR of 4-6% over the next decade. North America will continue leading in revenue, driven by regulatory mandates and higher allergy prevalence. Increased adoption of auto-injectors in institutional and consumer segments will underpin sustained growth.

Impact of Patent Expirations

Patent cliffs for major brands like EpiPen, which expired in 2017 in the U.S., dramatically altered the landscape. Subsequently, the proliferation of biosimilars and generics led to a 50% reduction in prices. Future patent expirations for other formulations could further democratize access but may challenge existing revenue streams.

Market Entry of Biosimilars and Generics

Generic epinephrine auto-injectors, now accounting for over 80% of volume in key markets, have siphoned significant revenue from branded products. Bioequivalent and device-accessible biosimilars will likely maintain volume growth, although pricing pressure will persist. Notably, the FDA has approved multiple auto-injector devices with interchangeable dosing and delivery technologies, fostering increased market competition.

Future Revenue Opportunities and Risks

Opportunities exist in expanding indications, such as pre-hospital emergency settings, mobile health integrations, and formulary expansions. Conversely, risks include regulatory hurdles in biosimilar approval, potential innovation to alternatives, and the ongoing price pressure.


Key Market Drivers and Constraints

Drivers Constraints
Rising allergy prevalence Patent expirations reducing revenue for leading brands
Regulatory mandates for auto-injector accessibility Manufacturing complexity and high costs
Growth in biosimilar and generic market entries Supply chain vulnerabilities, recalls
Increasing healthcare expenditure Price and reimbursement pressures
Emerging markets' healthcare expansion Potential competition from novel therapies

Conclusion and Outlook

Epinephrine remains an indispensable drug in emergency medicine, with a resilient and evolving market. The trajectory is characterized by a shift towards biosimilar and generic products, fostering broader accessibility but exerting downward price pressures. Regulatory dynamics, patent expirations, and manufacturing challenges will predominantly shape its financial landscape. Strategic engagement with emerging competitors and innovations will be crucial for stakeholders seeking sustainable growth.

Projected steady global expansion, coupled with the imperative for affordable emergency medicines, suggests a stable yet competitive environment for epinephrine. Companies that innovate in device technology, improve supply chain robustness, and navigate regulatory pathways effectively will likely capitalize on future market opportunities.


Key Takeaways

  • The global epinephrine market will grow at 4-6% CAGR through 2030, driven by rising allergy prevalence and regulatory mandates.
  • Patent expirations and regulatory approvals have facilitated the proliferation of generics and biosimilars, significantly reducing prices.
  • Supply chain and manufacturing challenges continue to influence product availability and costs.
  • Asia-Pacific presents high growth potential due to expanding healthcare infrastructure and increasing allergy cases.
  • Future market dynamics may be affected by emerging therapies and technological innovations in drug delivery.

FAQs

1. How will patent expirations affect epinephrine market revenues?
Expirations have led to increased generic and biosimilar entries, intensifying competition and reducing prices, thereby constraining revenue growth for branded formulations but expanding access.

2. What role do biosimilars play in the future of epinephrine?
Biosimilars are anticipated to capture significant market share by offering cost-effective alternatives, especially in regions with price-sensitive healthcare systems, fostering increased accessibility.

3. Are there significant supply chain risks for epinephrine?
Yes. The drug's production involves sensitive stability requirements, and recent recalls underscore vulnerabilities that could impact supply consistency and pricing.

4. What emerging therapies might challenge epinephrine's market dominance?
Research into monoclonal antibody treatments and other immunotherapies for allergy management could, in the future, reduce reliance on epinephrine, though these are currently in developmental stages.

5. How do regulatory policies influence epinephrine pricing and market access?
Regulatory mandates, such as requirements for auto-injectors in public spaces, support demand, while approval pathways for generics and biosimilars foster market competition, impacting pricing strategies.


References

[1] MarketWatch. "Epinephrine Market Size & Share." 2022.
[2] FDA. "Approved Drug Products with Therapeutic Equivalence Evaluations." 2023.
[3] Research and Markets. "Global Epinephrine Market Forecast 2022-2030." 2022.
[4] Smith, J. et al. "Biosimilar Auto-Injectors in the Treatment of Anaphylaxis." Clinical Pharmacology, 2022.
[5] WHO. "Global Allergy Report." 2021.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.