Epinephrine bitartrate; prilocaine hydrochloride - Generic Drug Details

What are the generic sources for epinephrine bitartrate; prilocaine hydrochloride and what is the scope of patent protection?

Epinephrine bitartrate; prilocaine hydrochloride is the generic ingredient in three branded drugs marketed by Astrazeneca, Dentsply Pharm, and Septodont Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for epinephrine bitartrate; prilocaine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
DailyMed Link:	epinephrine bitartrate; prilocaine hydrochloride at DailyMed

Pharmacology for epinephrine bitartrate; prilocaine hydrochloride

Drug Class	Amide Local Anesthetic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for epinephrine bitartrate; prilocaine hydrochloride

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

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous 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

US Patents and Regulatory Information for epinephrine bitartrate; prilocaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CITANEST FORTE	epinephrine bitartrate; prilocaine hydrochloride	INJECTABLE;INJECTION	014763-008	Approved Prior to Jan 1, 1982		DISCN	No	No
Septodont Inc	PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	epinephrine bitartrate; prilocaine hydrochloride	INJECTABLE;INJECTION	078959-001	Aug 30, 2011	AP	RX	No	No
Dentsply Pharm	CITANEST FORTE DENTAL	epinephrine bitartrate; prilocaine hydrochloride	INJECTABLE;INJECTION	021383-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

Epinephrine bitartrate; prilocaine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinephrine and Related Drugs

Introduction

Epinephrine, a crucial medication for treating severe allergic reactions, cardiac arrest, and other emergency conditions, is a significant player in the pharmaceutical market. This article delves into the market dynamics and financial trajectory of epinephrine and related drugs, such as epinephrine bitartrate and prilocaine hydrochloride.

Global Market Size and Growth

The global epinephrine market has been experiencing substantial growth. As of 2023, the market size was valued at $1.92 billion and is projected to grow to $4.60 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 10.2% during the forecast period[3].

Regional Dominance

North America, particularly the U.S., dominates the global epinephrine market, holding a significant share of 63.54% in 2023. The U.S. epinephrine market is expected to reach an estimated value of $2.81 billion by 2032, driven by the increasing prevalence of cardiac arrest and allergic reactions[3].

Market Segments

The market is segmented into various channels, with the retail and online pharmacy segment dominating in 2023. This segment's growth is attributed to the increasing number of retail and online pharmacy stores globally, along with easy accessibility of products such as auto-injectors. The hospital pharmacy segment is also expected to grow substantially due to the rising number of emergency hospital visits for severe allergic reactions, cardiac arrest, and respiratory conditions[3].

Product Forms and Uses

Epinephrine is administered through various forms, including intramuscular, subcutaneous, intravenous, and inhalation. It is used to treat anaphylaxis, asthma attacks, hypotension, shock, and other critical conditions. The versatility and critical nature of epinephrine contribute significantly to its market demand[4].

Competitive Landscape

The market for epinephrine and related drugs is characterized by a mix of competition and consolidation. For instance, the generic drug market has seen significant consolidation through mergers and acquisitions, which can impact the availability and pricing of drugs. Companies like Mylan, Teva, and Takeda have been involved in major acquisitions, affecting the competitive landscape[1].

Pricing and Accessibility

The pricing of epinephrine products has been a subject of concern. For example, the price of EpiPen, a widely used epinephrine auto-injector, has seen significant increases over the years, making it less accessible to some consumers. Similar issues have been observed with other drugs like Praziquantel, where the lack of generic competition allowed Bayer to increase prices substantially[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of epinephrine. FDA approvals and regulatory requirements can significantly impact the launch and continued availability of epinephrine products. For instance, the FDA's review process for new epinephrine products, such as Adamis Pharmaceuticals' epinephrine injection, involves rigorous safety and efficacy evaluations[5].

Financial Impact of Consolidation

The consolidation in the generic drug market has financial implications, including reduced competition and potential price increases. For example, the acquisition of smaller companies by larger pharmaceutical firms can lead to reduced generic competition, allowing the remaining players to increase prices. This trend has been observed in the generic market, with significant mergers and acquisitions in recent years[1].

Reimbursement Policies

Favorable reimbursement policies have also been a driving factor in the growth of the epinephrine market. Easy reimbursement processes for epinephrine products, especially through retail and online pharmacies, have increased their accessibility and contributed to market growth[3].

Future Outlook

The future outlook for the epinephrine market is promising, driven by increasing demand for emergency treatments and advancements in product formulations. The growing prevalence of allergic reactions and cardiac arrest, coupled with new product launches and favorable reimbursement policies, is expected to sustain market growth over the forecast period[3].

Key Takeaways

• The global epinephrine market is projected to grow significantly, driven by increasing demand and favorable market conditions.
• North America, particularly the U.S., dominates the global market.
• The retail and online pharmacy segment is a major driver of market growth.
• Regulatory approvals and reimbursement policies play critical roles in market dynamics.
• Consolidation in the generic drug market can impact pricing and accessibility.

FAQs

Q: What is the projected growth rate of the global epinephrine market? A: The global epinephrine market is projected to grow at a CAGR of 10.2% from 2024 to 2032[3].

Q: Which region dominates the global epinephrine market? A: North America, particularly the U.S., dominates the global epinephrine market[3].

Q: What are the primary uses of epinephrine? A: Epinephrine is used to treat severe allergic reactions (anaphylaxis), asthma attacks, hypotension, shock, and other critical conditions[4].

Q: How has consolidation affected the generic drug market? A: Consolidation has reduced competition and led to potential price increases in the generic drug market[1].

Q: What role do reimbursement policies play in the epinephrine market? A: Favorable reimbursement policies have increased the accessibility of epinephrine products, contributing to market growth[3].

Sources

1. Congresswoman Jan Schakowsky. Costly Cures: The Human and Economic Costs of the Broken Biotech Patent System. December 2019.
2. FDA. 204200Orig1s000 204200Orig2s000. accessdata.fda.gov.
3. Fortune Business Insights. Epinephrine Market Size, Share, Growth & Forecast [2032]. fortunebusinessinsights.com.
4. UMB Digital Archive. Epinephrine hydrochloride. archive.hshsl.umaryland.edu.
5. FDA. 207534Orig1s000. accessdata.fda.gov.