Methadone hydrochloride - Generic Drug Details

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

Methadone hydrochloride is the generic ingredient in five branded drugs marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Sandoz, Vistapharm, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for methadone hydrochloride. Seventeen suppliers are listed for this compound.

Summary for methadone hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	16
NDAs:	33
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	372
Patent Applications:	7,709
Drug Prices:	Drug price trends for methadone hydrochloride
What excipients (inactive ingredients) are in methadone hydrochloride?	methadone hydrochloride excipients list
DailyMed Link:	methadone hydrochloride at DailyMed

See drug prices for methadone hydrochloride

Recent Clinical Trials for methadone hydrochloride

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	Phase 2
BC Centre on Substance Use	Phase 2
The University of Texas Health Science Center, Houston	Phase 4

See all methadone hydrochloride clinical trials

Pharmacology for methadone hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for methadone hydrochloride

Analgesics, Opioid

Antitussive Agents

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for methadone hydrochloride

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for methadone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	POWDER;FOR RX COMPOUNDING	006383-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Vistapharm Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	204166-001	Mar 16, 2020	AA	RX	No	No
Vistapharm	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET, FOR SUSPENSION;ORAL	075082-001	Mar 25, 1998	AA	RX	No	No
Sandoz	WESTADONE	methadone hydrochloride	TABLET, EFFERVESCENT;ORAL	017108-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Vistapharm Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	SOLUTION;ORAL	090707-002	Jun 30, 2010		DISCN	No	No
Specgx Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	CONCENTRATE;ORAL	207368-001	Aug 22, 2019	AA	RX	No	No
Long Grove Pharms	METHADONE HYDROCHLORIDE	methadone hydrochloride	INJECTABLE;INJECTION	208306-001	Oct 27, 2017	AP	RX	No	No

Methadone hydrochloride Market Analysis and Financial Projection Experimental

Methadone Hydrochloride Market Dynamics and Financial Trajectory

Introduction to Methadone Hydrochloride

Methadone hydrochloride, a synthetic opioid, is widely used for treating chronic pain and opioid use disorder. It is sold under various brand names, including Dolophine and Methadose. Understanding the market dynamics and financial trajectory of methadone hydrochloride is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth Projections

The global methadone hydrochloride market is anticipated to experience significant growth over the coming years. Here are some key projections:

• Current Market Size: As of 2024, the global methadone hydrochloride market size is estimated to be around $67 million[1][4].
• Forecasted Market Size: By 2030, the market is expected to reach $89 million, growing at a Compound Annual Growth Rate (CAGR) of 4.8% during the forecast period from 2024 to 2030[1][4].
• Alternative Projections: Another forecast suggests the market could reach $184.8 million by 2030, growing at a CAGR of around 5.5% from 2023[3].

Drivers of Market Growth

Several factors are driving the growth of the methadone hydrochloride market:

Increasing Prevalence of Chronic Pain

The rising prevalence of chronic pain associated with therapeutic and post-surgical treatments, particularly in cancer and other chronic diseases, is a significant driver. Patients who require long-term pain management often turn to methadone when alternative options are not viable[4].

Methadone Maintenance Therapy

Methadone maintenance therapy (MMT) for opioid use disorder is another major driver. MMT involves long-term administration of methadone to help patients manage withdrawal symptoms and reduce cravings for illicit opioids[5].

Global Drug Use Trends

The increasing global use of opioids and the subsequent need for treatment and maintenance therapies also contribute to the market's growth[4].

Regional Insights

The methadone hydrochloride market is geographically diverse, with different regions contributing significantly:

North America

This region is expected to hold a leading position in the global methadone hydrochloride market. The high prevalence of chronic pain in the United States, where over 1 in 5 people reported chronic pain in 2018, drives the demand for methadone. The presence of key vendors in North America also supports market growth[4].

Asia Pacific

While North America leads, the Asia Pacific region is also significant due to the higher frequency of chronic pain associated with cancer and post-surgical treatments[4].

Key Industry Players

Several companies are prominent in the methadone hydrochloride market:

• Roxane Laboratories
• Mallinckrodt
• Siegfried Ltd
• MACFARLAN SMITH
• Tianjin Central Pharma[1][4].

Financial Trajectory

The financial trajectory of the methadone hydrochloride market is characterized by steady growth:

• Revenue Forecast: The market is projected to grow from $67 million in 2024 to $89 million by 2030, or alternatively to $184.8 million by 2030, depending on the forecast model[1][3].
• CAGR: The expected CAGR ranges from 4.8% to 5.5% over the forecast period, indicating a stable and growing market[1][3][4].

Challenges and Risks

Despite the growth, the methadone hydrochloride market faces several challenges:

Mortality and Adverse Effects

Methadone is associated with a high risk of overdose, especially when combined with other drugs like benzodiazepines. In the U.S., deaths linked to methadone more than quadrupled between 1999 and 2004, highlighting the need for careful dosing and monitoring[2].

Diversion and Misuse

Methadone can be diverted and misused, leading to health dangers such as overdose, respiratory depression, and heart rhythm disruptions. This nonmedical use can further complicate addiction issues[5].

Conclusion

The methadone hydrochloride market is poised for significant growth driven by the increasing prevalence of chronic pain and the need for opioid use disorder treatment. However, it is crucial to address the challenges associated with methadone use, such as overdose risks and diversion.

Key Takeaways

• The global methadone hydrochloride market is expected to grow from $67 million in 2024 to $89 million by 2030 at a CAGR of 4.8%.
• The market is driven by the increasing prevalence of chronic pain and the demand for methadone maintenance therapy.
• North America is expected to lead the market, followed by the Asia Pacific region.
• Key industry players include Roxane Laboratories, Mallinckrodt, and Siegfried Ltd.
• The market faces challenges such as overdose risks and diversion.

FAQs

What is the current market size of the methadone hydrochloride market?

The current market size of the methadone hydrochloride market is estimated to be around $67 million as of 2024[1][4].

What is the forecasted market size of the methadone hydrochloride market by 2030?

The forecasted market size of the methadone hydrochloride market by 2030 is expected to be around $89 million[1].

What is the CAGR of the methadone hydrochloride market from 2024 to 2030?

The CAGR of the methadone hydrochloride market from 2024 to 2030 is expected to be around 4.8%[1][4].

What are the primary drivers of the methadone hydrochloride market?

The primary drivers of the methadone hydrochloride market include the increasing prevalence of chronic pain and the demand for methadone maintenance therapy for opioid use disorder[4].

Which region is expected to lead the methadone hydrochloride market?

North America is expected to lead the methadone hydrochloride market due to the high prevalence of chronic pain and the presence of key vendors in the region[4].

Sources

1. Global Methadone Hydrochloride Market Insights, Forecast to 2030 - Valuates Reports
2. Methadone - Wikipedia
3. Methadone Market Set for Strong Growth Trajectory, Projected to Reach $184.8 Million by 2030 - GlobeNewswire
4. Methadone Hydrochloride Market | Global Industry Report, 2031 - Business Research Insights
5. Methadone Treatment - Greenhouse Treatment Center