Epinephrine - Generic Drug Details

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

Epinephrine is the generic ingredient in thirty-five branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Viatris, Impax, Teva Pharms Usa, Ph Health, Am Regent, Amneal, Apotex, Baxter Hlthcare Corp, Bpi Labs, Deva Hlding, Fresenius Kabi Usa, Gland, Hikma, Intl Medication Sys, Zydus Pharms, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 3M, 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 seventy-five NDAs. There are twenty-eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Thirty-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for epinephrine

International Patents:	239
US Patents:	28
Tradenames:	35
Applicants:	40
NDAs:	72
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	824
Patent Applications:	6,198
Drug Prices:	Drug price trends for epinephrine
Drug Sales Revenues:	Drug sales revenues for epinephrine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for epinephrine
What excipients (inactive ingredients) are in epinephrine?	epinephrine excipients list
DailyMed Link:	epinephrine at DailyMed

See drug prices for epinephrine

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

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

Sponsor	Phase
University of California, San Francisco	PHASE2
Hospital del Trabajador de Santiago	NA
Goldman, Butterwick, Fitzpatrick and Groff	PHASE4

See all epinephrine clinical trials

Generic filers with tentative approvals for EPINEPHRINE

Applicant	Application No.	Strength	Dosage Form
		EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
		EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS
		EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION;INTRAVENOUS

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

Pharmacology for epinephrine

Drug Class	Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for epinephrine

Adrenergic alpha-Agonists

Adrenergic beta-Agonists

Bronchodilator Agents

Mydriatics

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for epinephrine

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for EPINEPHRINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEFFY	Nasal Spray	epinephrine	1 mg/spray	214697	1	2025-12-29
NEFFY	Nasal Spray	epinephrine	2 mg/spray	214697	1	2025-06-30
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes	8,226,610		Y
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-002	Mar 5, 2025		RX	Yes	Yes	11,918,655
Amneal	EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	217485-001	Oct 14, 2025	AP	RX	No	No
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013	AP	RX	Yes	Yes	9,295,657
Intl Medication Sys	EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS	211363-001	Aug 15, 2022		RX	Yes	Yes
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No	8,206,360		Y
Astrazeneca	DURANEST	epinephrine bitartrate; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for epinephrine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	8,926,594
Viatris	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	8,048,035
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	9,737,669
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017	7,731,686
Impax	TWINJECT	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003	7,621,891
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	7,731,686
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	9,056,170

International Patents for epinephrine

Country	Patent Number	Title	Estimated Expiration
Australia	2016233682	Epinephrine formulations
Canada	2978464	FORMULATIONS D'EPINEPHRINE (EPINEPHRINE FORMULATIONS)
China	107614017	肾上腺素制剂 (EPINEPHRINE FORMULATIONS)
European Patent Office	3268045	FORMULATIONS D'ÉPINÉPHRINE (EPINEPHRINE FORMULATIONS)
Japan	2018507915	エピネフリン製剤
South Korea	20180034307	에피네프린 제형
World Intellectual Property Organization (WIPO)	2016149028

Supplementary Protection Certificates for epinephrine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211
3678649	C20250011	Finland
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823

Epinephrine Market Dynamics, Financial Trajectory, Patent Risk, and Competitive Outlook

Last updated: November 8, 2026

Epinephrine is a large, fragmented emergency-medicine market dominated by generic injectable products and differentiated delivery systems. The commercial center of gravity shifted from Mylan’s EpiPen franchise to a multi-product market that includes authorized generics, AUVI-Q, prefilled syringes, vials, auto-injectors, and ARS Pharmaceuticals’ neffy intranasal epinephrine. Financial growth depends less on the active ingredient than on device design, portability, reimbursement, institutional purchasing, and supply reliability.

How large is the epinephrine market?

No single company reports global epinephrine revenue as a standalone category. Market estimates vary based on whether they include hospital injectables, auto-injectors, nasal products, veterinary products, and international sales.

The U.S. market has four commercially important segments:

Segment	Principal products	Main customers	Commercial characteristics
Auto-injectors	EpiPen, EpiPen Jr., generic epinephrine auto-injectors, AUVI-Q	Retail pharmacies, schools, families, emergency kits	Highest unit prices and strongest brand differentiation
Intranasal epinephrine	neffy	Patients, caregivers, schools, emergency systems	New delivery category; no needle required
Prefilled syringes	Various hospital products	Hospitals, emergency departments, ambulances	Institutional procurement and shortage sensitivity
Vials and ampules	Generic epinephrine injection	Hospitals, clinics, emergency services	Lowest-cost, mature generic segment

Auto-injectors generate the greatest branded revenue per treatment unit. Injectable epinephrine remains essential in hospitals but has limited pricing power because multiple generic suppliers compete for institutional contracts.

The market is structurally defensive. Epinephrine is a first-line treatment for anaphylaxis, has no therapeutic substitute in acute emergency use, and is commonly prescribed in pairs because a second dose may be needed before emergency services arrive. Demand is supported by food allergies, insect-sting allergies, medication reactions, public-access programs, school stocking laws, and broader allergy awareness.[1]

What is the financial trajectory of epinephrine?

The financial trajectory has three phases: premium auto-injector expansion, post-EpiPen pricing correction, and delivery-system diversification.

EpiPen revenue peaked before generic competition

Mylan’s EpiPen franchise generated more than $1 billion in annual revenue at its peak, driven by price increases, replacement prescriptions, two-pack dispensing, and broad physician and school adoption.[2] The product’s financial performance was substantially larger than the underlying cost of epinephrine because the value proposition rested on the delivery device, packaging, distribution, and brand recognition.

Public criticism of EpiPen pricing accelerated payer intervention and political scrutiny in 2016. Mylan responded with an authorized generic and patient assistance initiatives. Teva received FDA approval for a generic EpiPen in 2018, increasing competitive pressure.[3]

The result was a sharp decline in EpiPen pricing power. Generic competition reduced the addressable premium for the Mylan/Viatris product, while pharmacies and payers increased substitution toward lower-cost options.

Generic competition has lowered revenue per prescription

Generic epinephrine auto-injectors compete primarily on:

• Wholesale acquisition cost
• Pharmacy coverage
• Supply reliability
• Device familiarity
• Training materials
• School and institutional purchasing terms

The active pharmaceutical ingredient is inexpensive relative to the complete product. Manufacturers incur costs for device engineering, assembly, human-factors testing, packaging, stability, regulatory compliance, and distribution. These factors limit the extent to which retail prices can fall toward the cost of injectable epinephrine.

New delivery systems create premium pricing opportunities

AUVI-Q differentiates itself through compact design, voice instructions, and automated operation. Kaleo has used a specialty-pharmacy and direct-distribution model to target patients who value device usability and portability.[4]

neffy creates a separate commercial category. The FDA approved neffy in August 2024 for emergency treatment of allergic reactions, including anaphylaxis, in adults and pediatric patients weighing at least 30 kilograms.[5] Its nasal delivery avoids injection, which may improve acceptance among children, needle-averse patients, caregivers, and public-access programs.

ARS Pharmaceuticals has not yet established a long-term commercial revenue record for neffy. Its financial trajectory depends on four factors:

1. Whether prescribers view nasal delivery as interchangeable with auto-injectors.
2. Whether insurers place neffy on preferred formularies.
3. Whether patients carry and use the product reliably.
4. Whether regulators and clinicians expand confidence in nasal administration during severe reactions.

How does the epinephrine competitive landscape compare?

Company or product	Delivery system	Commercial position	Principal risk
Viatris EpiPen	Auto-injector	Established brand with global recognition	Generic erosion and payer substitution
Generic EpiPen equivalents	Auto-injector	Price-driven retail competition	Manufacturing and supply consistency
Kaleo AUVI-Q	Auto-injector	Differentiated compact device with voice prompts	Reimbursement and niche scale
ARS Pharmaceuticals neffy	Nasal spray	First FDA-approved intranasal epinephrine product	Adoption, education, and clinical preference
Hospital generic suppliers	Syringe, vial, ampule	Institutional standard products	Shortages, procurement pricing, manufacturing interruptions

EpiPen retains brand equity, but brand recognition no longer guarantees premium pricing. AUVI-Q competes through device experience rather than ingredient differentiation. neffy has the greatest category-expansion potential because it removes the needle from emergency epinephrine administration.

What is the FDA regulatory status of epinephrine products?

Epinephrine products use several FDA regulatory pathways:

• 505(b)(1) or abbreviated pathways for conventional injectable products.
• Abbreviated new drug applications for generic auto-injectors and injections.
• 505(b)(2) strategies for products using an established active ingredient with a new delivery system or formulation.
• New drug applications for proprietary devices or delivery technologies.

The FDA approved generic EpiPen products after requiring evidence that the device and drug product performed consistently. For auto-injectors, regulatory risk includes dose accuracy, activation force, needle deployment, injection depth, labeling, storage, and human-factors performance.[3]

neffy’s approval demonstrates that intranasal delivery can obtain FDA authorization for emergency anaphylaxis treatment. Its approval was based on pharmacokinetic and pharmacodynamic evidence, including comparisons with approved injectable epinephrine products.[5]

Epinephrine is not a biologic. Biosimilar regulation does not apply. The relevant competitive pathways are generic drug applications, device-enabled combination products, and 505(b)(2) products.

What patents protect epinephrine products?

The core epinephrine molecule is long off patent. Commercial protection depends on device architecture, formulation, manufacturing processes, packaging, and regulatory exclusivity.

EpiPen patent position

EpiPen’s historic patent estate included auto-injector mechanisms, cartridge arrangements, dose delivery systems, and related device configurations. Key protection expired or weakened over time, allowing generic auto-injector entry. The product’s commercial moat was therefore based more on market scale and brand adoption than on durable composition-of-matter protection.

The most relevant patent risks for an EpiPen competitor have involved:

• Device geometry
• Needle concealment and deployment
• Cartridge and plunger structures
• Automatic dose delivery
• Two-pack packaging
• Manufacturing and assembly processes

Once generic manufacturers secured FDA approval, the remaining patent estate did not prevent meaningful substitution.

AUVI-Q and device patents

AUVI-Q has relied on proprietary device features, including compact form factor, electronic voice guidance, and automated instructions. Those features can support patent protection and trade-secret protection, but they also create manufacturing and lifecycle-management costs.

The commercial value of AUVI-Q depends on whether the device’s usability advantages justify reimbursement above generic auto-injector prices.

neffy patent and regulatory protection

neffy’s protection is expected to center on nasal delivery, formulation, absorption, device configuration, dosing, and methods of treating anaphylaxis with intranasal epinephrine. The principal competitive barrier is not the epinephrine molecule. It is the combination of formulation performance, delivery technology, clinical evidence, FDA approval, and manufacturing know-how.

Patent durability will depend on the breadth and enforceability of issued claims. A competing nasal product could attempt to design around formulation, spray-device, dose, or treatment-method claims.

When does epinephrine lose exclusivity?

Epinephrine itself has no meaningful remaining molecule exclusivity. Product-level exclusivity differs by delivery system.

Product category	Exclusivity position
Injectable epinephrine	Mature generic market
EpiPen auto-injector	Generic competition established
AUVI-Q	Device and product differentiation remain relevant
neffy	New-product regulatory and patent protection began with 2024 approval
New nasal competitors	Potential future 505(b)(2) or other approval pathways

The practical loss of exclusivity for EpiPen occurred when approved generic auto-injectors reached the market, not when every device patent expired. In this category, FDA-approved substitution and payer behavior can erode revenue before a complete patent expiration analysis is available.

What Orange Book and Paragraph IV risks affect epinephrine?

Orange Book exposure is product-specific. Injectable epinephrine products generally have limited patent barriers because they are mature generics. Auto-injectors and newer delivery systems may have listed patents covering device or formulation elements.

Paragraph IV risk is most relevant to proprietary products such as neffy and any future branded auto-injector with listed patents. A generic or follow-on applicant could allege that patents are invalid, unenforceable, or not infringed. The patent holder could then file an infringement action within the statutory period, potentially triggering a 30-month stay of approval under the Hatch-Waxman framework.[6]

For EpiPen, Paragraph IV litigation did not prevent eventual generic entry. The commercial outcome showed that patent disputes could delay competition but could not preserve the original premium indefinitely.

What generic launch scenarios exist for epinephrine?

Scenario 1: Continued generic price erosion

Generic auto-injector prices continue to decline as additional suppliers enter and payers standardize preferred products. This scenario benefits Medicaid, commercial insurers, schools, and public-access programs but compresses manufacturer margins.

Scenario 2: Branded-device segmentation

EpiPen, AUVI-Q, and neffy retain differentiated segments based on ease of use, portability, training, and patient preference. Pricing remains higher for products with measurable adherence or usability advantages.

Scenario 3: Nasal product expansion

neffy gains adoption in children, schools, workplaces, and public emergency kits. Competitors pursue additional nasal epinephrine products, potentially creating a new generic and branded market.

Scenario 4: Supply-driven repricing

Manufacturing interruptions or shortages shift demand among suppliers. FDA shortage records have shown that injectable epinephrine supply can be vulnerable to manufacturing and distribution problems.[7] A reliable supplier can gain share even without the lowest price.

What manufacturing and intellectual-property barriers affect the market?

Epinephrine has a relatively simple active ingredient but a demanding finished-product profile. Manufacturers must control:

• Oxidative degradation
• Light sensitivity
• Dose uniformity
• Container closure integrity
• Device activation and injection performance
• Nasal spray plume and droplet distribution
• Stability through labeled shelf life
• Cold-chain or storage requirements where applicable

The principal barrier for auto-injectors is combination-product manufacturing. The principal barrier for nasal epinephrine is consistent intranasal absorption during emergency use, including patients with congestion, vomiting, or compromised nasal conditions.

Manufacturing scale is commercially important. Product shortages can cause rapid prescription switching, while unreliable supply can eliminate the advantage of a lower price.

Which companies are most exposed to epinephrine revenue changes?

Viatris has the largest historical exposure through EpiPen, but its portfolio is diversified and it does not report EpiPen as an independent current financial segment.[8] Kaleo is more concentrated in AUVI-Q and related specialty products. ARS Pharmaceuticals is highly exposed to neffy’s launch trajectory because the product is central to its commercial strategy.[9]

Hospitals and public-health systems have lower financial exposure but greater operational exposure. Shortages can affect emergency preparedness, formulary continuity, and ambulance stocking.

What patent litigation and settlement activity affect epinephrine?

The most consequential historical disputes involved EpiPen pricing, generic entry, and competition rather than long-term exclusion from the market. Mylan faced extensive scrutiny over EpiPen pricing practices and market conduct, while generic competition proceeded through FDA approvals and commercial substitution.[2][3]

There is no biosimilar litigation pathway for epinephrine. Future disputes are more likely to concern:

• Patent validity for nasal formulations
• Auto-injector device claims
• Orange Book patent listings
• Regulatory exclusivity
• Product-specific labeling
• Antitrust or access claims related to school and emergency markets

Key Takeaways

• Epinephrine is a mature active-ingredient market with substantial value in delivery systems.
• EpiPen revenue exceeded $1 billion annually at its peak but declined after generic entry and pricing scrutiny.
• Generic auto-injectors have structurally reduced retail pricing power.
• AUVI-Q competes through device usability and patient experience.
• neffy, approved by the FDA in 2024, is the main new growth platform and the first major needle-free U.S. epinephrine product.
• Biosimilar risk does not apply because epinephrine is a small-molecule drug.
• The strongest remaining barriers are device patents, nasal formulation know-how, manufacturing reliability, and regulatory execution.
• Future revenue growth depends on product differentiation, payer access, and expansion of public-access epinephrine programs.
• Generic launch risk is highest for mature injectable and auto-injector products and lower, but rising, for newer nasal delivery systems.

FAQs

Is epinephrine a profitable pharmaceutical product?

Yes, but profitability varies sharply by delivery system. Injectable epinephrine is heavily commoditized, while branded auto-injectors and nasal products can command higher prices because of device and usability differentiation.

Why did EpiPen revenue decline?

Revenue declined because of generic competition, payer substitution, public pricing scrutiny, lower net prices, and the availability of authorized and independent generic alternatives.

Can a generic company copy neffy?

A generic or follow-on company could pursue an FDA pathway if it can meet regulatory requirements and avoid or invalidate applicable patents. The main barriers would involve formulation, nasal-device performance, clinical evidence, and patent claims.

Does epinephrine have biosimilar competition?

No. Epinephrine is a small-molecule drug, so competitors enter through generic drug applications, device-enabled products, or 505(b)(2) applications rather than biosimilar applications.

Will nasal epinephrine replace auto-injectors?

Nasal epinephrine is more likely to expand the market and capture selected segments than immediately replace auto-injectors. Patient preference, clinical confidence, insurance coverage, storage, and performance during severe reactions will determine the balance.

References

1. Centers for Disease Control and Prevention. (2023). Food allergies in schools and early care and education programs. U.S. Department of Health and Human Services.

2. U.S. Securities and Exchange Commission. (2017). Mylan N.V. annual report on Form 10-K for fiscal year 2016.

3. U.S. Food and Drug Administration. (2018). FDA approves first generic version of EpiPen. U.S. Department of Health and Human Services.

4. Kaleo, Inc. (2023). AUVI-Q product information and company materials.

5. U.S. Food and Drug Administration. (2024). FDA approves first nasal spray for emergency treatment of allergic reactions, including anaphylaxis. U.S. Department of Health and Human Services.

6. U.S. Food and Drug Administration. (2023). Guidance for industry: 180-day exclusivity when multiple ANDAs are submitted on the same day. U.S. Department of Health and Human Services.

7. U.S. Food and Drug Administration. (2024). Drug shortages: Epinephrine injection. U.S. Department of Health and Human Services.

8. Viatris Inc. (2023). Annual report on Form 10-K for fiscal year 2023.

9. ARS Pharmaceuticals, Inc. (2023). Annual report on Form 10-K for fiscal year 2023.