ALFENTANIL HYDROCHLORIDE - Generic Drug Details

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

Alfentanil hydrochloride is the generic ingredient in two branded drugs marketed by Rising and Hospira, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for alfentanil hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ALFENTANIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	50
Patent Applications:	532
What excipients (inactive ingredients) are in ALFENTANIL HYDROCHLORIDE?	ALFENTANIL HYDROCHLORIDE excipients list
DailyMed Link:	ALFENTANIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ALFENTANIL HYDROCHLORIDE

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Region Jönköping County	Phase 4
Region Östergötland	Phase 4

See all ALFENTANIL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ALFENTANIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.5MG BASE/ML	INJECTABLE;INJECTION

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 ALFENTANIL HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for ALFENTANIL HYDROCHLORIDE

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for ALFENTANIL HYDROCHLORIDE

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for ALFENTANIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986	AP	RX	Yes	Yes
Hospira	ALFENTANIL	alfentanil hydrochloride	INJECTABLE;INJECTION	075221-001	Oct 28, 1999	AP	RX	No	No

Expired US Patents for ALFENTANIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986	4,167,574

ALFENTANIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alfentanil Hydrochloride

Introduction to Alfentanil Hydrochloride

Alfentanil hydrochloride is a synthetic, short-acting opioid analgesic, classified as a small-molecule derivative of fentanyl. It is widely used in medical settings for its potent analgesic and anesthetic properties, particularly during surgical procedures and as a primary anesthetic agent in cardiac surgery[2].

Market Overview

The global opioids market, which includes alfentanil hydrochloride, is projected to grow significantly over the coming years. As of 2023, the global opioids market size was valued at approximately $22.74 billion and is expected to reach around $26.78 billion by 2034, growing at a CAGR of 1.5% from 2024 to 2034[4].

Applications and End-Uses

Alfentanil hydrochloride is primarily used in several key medical applications:

• General Anesthesia: It is used as a general anesthetic agent in high doses during cardiac surgery and other surgical procedures.
• Monitored Anesthesia Care: Approved by the FDA for use in monitored anesthesia care, it serves as an analgesic supplement.
• Pain Relief: Used as an analgesic adjunct in various medical settings, including post-surgical pain management[2].

Market Segmentation

The opioids market, including alfentanil hydrochloride, can be segmented in several ways:

• By Application: The pain relief segment holds a significant market share, but the anesthesia segment is expected to grow at the fastest CAGR during the forecast period.
• By Route of Administration: The injectable segment currently holds the highest revenue share, but the oral segment is anticipated to expand at a CAGR of 2.5% over the predicted period.
• By Distribution Channel: Retail pharmacies lead the market with the maximum market share, followed by hospital pharmacies[4].

Key Players and Manufacturers

Several major pharmaceutical companies are involved in the production and distribution of alfentanil hydrochloride:

• Teva Pharmaceuticals Inc.
• Mallinckrodt Pharmaceuticals LLC
• Purdue Pharmaceuticals L.P.
• Sun Pharmaceutical Industries Ltd
• Johnson and Johnson
• AbbVie Inc (Allergan PLC)
• Hikma Pharmaceuticals PLC

These companies play a crucial role in the manufacturing, pricing, and distribution of alfentanil hydrochloride[4].

Pricing and Cost Considerations

The pricing of alfentanil hydrochloride can vary based on several factors, including the route of administration, dosage, and geographical location. The cost is generally higher for injectable forms compared to oral forms. For instance, certified reference materials of alfentanil hydrochloride can range from $97.40 to several hundred dollars per unit, depending on the concentration and volume[5].

Market Trends and Forecast

The market for alfentanil hydrochloride is influenced by several trends:

• Growing Demand for Pain Management: The increasing need for effective pain management solutions drives the demand for opioids like alfentanil hydrochloride.
• Abuse-Deterrent Formulations: The FDA's support for abuse-deterrent formulations (ADFs) is expected to spur innovations in opioid formulations, potentially expanding market growth while addressing public health concerns[4].

Regulatory Environment

The use of alfentanil hydrochloride is heavily regulated due to its potential for abuse and addiction. FDA-approved indications include its use in general anesthesia and monitored anesthesia care. Off-label uses, such as acute pain management in children through nasal administration, are also noted but require careful clinical judgment[2].

Pharmacokinetics and Safety Considerations

Understanding the pharmacokinetics of alfentanil hydrochloride is crucial for its safe and effective use:

• Absorption and Distribution: Alfentanil is completely absorbed after intravenous administration, with a volume of distribution ranging from 0.4 to 1 L/kg and 92% protein binding.
• Metabolism and Elimination: It undergoes extensive hepatic metabolism via the CYP3A4 enzyme and is primarily excreted in the urine.
• Special Populations: Dosing adjustments are recommended for patients with hepatic or renal impairment, and careful consideration is needed for pregnant and breastfeeding patients[2].

Financial Implications

The financial trajectory of alfentanil hydrochloride is tied to the broader opioids market:

• Market Size and Growth: The projected growth of the opioids market to $26.78 billion by 2034 indicates a stable and growing financial outlook for alfentanil hydrochloride.
• Revenue Segments: The injectable segment, which includes alfentanil hydrochloride, holds a significant revenue share, contributing substantially to the overall market revenue[4].

Recent Developments and Initiatives

Several recent developments and initiatives impact the market dynamics of alfentanil hydrochloride:

• Emergency Opioid Overdose Treatment: Launches of over-the-counter naloxone hydrochloride nasal sprays by companies like Emergent BioSolutions and Amneal enhance accessibility to emergency treatment, indirectly influencing the use and regulation of opioids like alfentanil hydrochloride.
• Government Initiatives: The Biden-Harris Administration's initiative to support opioid treatment and recovery services in rural communities highlights ongoing efforts to address opioid misuse and addiction, which can impact market trends[4].

Challenges and Opportunities

The market for alfentanil hydrochloride faces several challenges and opportunities:

• Opioid Crisis: The ongoing opioid crisis, particularly the fentanyl crisis, poses significant challenges to the market, including regulatory scrutiny and public health concerns.
• Innovative Formulations: The development of abuse-deterrent formulations and other innovative technologies presents opportunities for market growth and safer opioid products[3][4].

Key Takeaways

• Alfentanil hydrochloride is a critical component of the opioids market, used primarily for anesthesia and pain relief.
• The global opioids market is projected to grow to $26.78 billion by 2034.
• Key players include major pharmaceutical companies like Teva and Mallinckrodt.
• Pricing and cost considerations vary by route of administration and geographical location.
• Regulatory environment and pharmacokinetics play crucial roles in the safe use of alfentanil hydrochloride.
• Recent developments and initiatives focus on addressing opioid misuse and improving treatment accessibility.

FAQs

What are the primary uses of alfentanil hydrochloride?

Alfentanil hydrochloride is primarily used as a general anesthetic agent and as an analgesic supplement during surgical procedures and monitored anesthesia care[2].

How does the FDA regulate alfentanil hydrochloride?

The FDA has approved alfentanil hydrochloride for use in general anesthesia and monitored anesthesia care, with specific guidelines for its administration and dosing[2].

What are the key market segments for alfentanil hydrochloride?

The market can be segmented by application (pain relief, anesthesia), route of administration (injectable, oral), and distribution channel (retail pharmacy, hospital pharmacy)[4].

How does the opioid crisis impact the market for alfentanil hydrochloride?

The opioid crisis, particularly the fentanyl crisis, poses significant challenges to the market, including regulatory scrutiny and public health concerns, but also drives the need for safer opioid formulations[3][4].

What are the future growth prospects for the alfentanil hydrochloride market?

The market is expected to grow as part of the broader opioids market, driven by increasing demand for pain management solutions and innovations in abuse-deterrent formulations[4].

Sources:

1. Research and Markets: Alfentanil (CAS 71195-58-9) Global Market Research Report 2024.
2. NCBI Bookshelf: Alfentanil - StatPearls.
3. House.gov: THE CCP'S ROLE IN THE FENTANYL CRISIS.
4. Biospace: Opioids Market Size to Worth Around USD 26.78 Billion by 2034.
5. Cerilliant: Alfentanil HCl - Certified Reference Materials.