PENICILLAMINE - Generic Drug Details

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

Penicillamine is the generic ingredient in four branded drugs marketed by Valeant Pharms Intl, Ani Pharms, Apotex, Breckenridge, Dr Reddys, Endo Operations, Granules, Invagen Pharms, Navinta Llc, Watson Labs Inc, Mylan Speciality Lp, Lupin Ltd, and Teva Pharms Usa, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for penicillamine. Fourteen suppliers are listed for this compound.

Summary for PENICILLAMINE

US Patents:	0
Tradenames:	4
Applicants:	13
NDAs:	14
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	17
Patent Applications:	7,057
Drug Prices:	Drug price trends for PENICILLAMINE
What excipients (inactive ingredients) are in PENICILLAMINE?	PENICILLAMINE excipients list
DailyMed Link:	PENICILLAMINE at DailyMed

See drug prices for PENICILLAMINE

Recent Clinical Trials for PENICILLAMINE

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

Sponsor	Phase
Nanfang Hospital, Southern Medical University	Phase 2
Alexion Pharmaceuticals	Phase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University	Early Phase 1

See all PENICILLAMINE clinical trials

Pharmacology for PENICILLAMINE

Drug Class

Antirheumatic Agent

Medical Subject Heading (MeSH) Categories for PENICILLAMINE

Antidotes

Antirheumatic Agents

Chelating Agents

Anatomical Therapeutic Chemical (ATC) Classes for PENICILLAMINE

M01CC	Penicillamine and similar agents
M01C	SPECIFIC ANTIRHEUMATIC AGENTS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for PENICILLAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	PENICILLAMINE	penicillamine	TABLET;ORAL	211497-001	Feb 13, 2020		DISCN	No	No
Lupin Ltd	PENICILLAMINE	penicillamine	TABLET;ORAL	212933-001	Nov 30, 2020	AB	RX	No	No
Apotex	PENICILLAMINE	penicillamine	CAPSULE;ORAL	213310-001	Apr 28, 2020	AB	RX	No	No
Endo Operations	PENICILLAMINE	penicillamine	TABLET;ORAL	211196-001	Dec 23, 2019	AB	RX	No	No

PENICILLAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Penicillamine

Introduction

Penicillamine is a chelating agent used primarily in the treatment of Wilson's disease, a rare genetic disorder that causes copper to accumulate in the body, and in some cases, for the treatment of rheumatoid arthritis and cystinuria. Here, we delve into the market dynamics and financial trajectory of penicillamine.

Market Size and Growth

The global penicillamine market has been steadily growing, albeit at a moderate pace. As of 2023, the market size was valued at approximately US$ 83 million[1][4].

• Forecasted Growth: The market is expected to reach US$ 91 million by 2030, with a Compound Annual Growth Rate (CAGR) of 1.3% during the forecast period of 2024-2030[1][4].

Driving Factors

Several factors are driving the growth of the penicillamine market:

Increasing Awareness and Diagnosis

• Growing awareness among people about Wilson's disease and other conditions treated by penicillamine is a significant driver. Organizations such as the Wilson's Disease Association are actively promoting awareness, leading to more diagnoses and treatments[3].

Pharmaceutical Demand

• The demand for penicillamine, along with other drugs like trientine and zinc, has seen a significant increase, particularly in retail pharmacies. This is due to the rising incidence of Wilson's disease and the need for effective treatments[3].

Research and Development

• Ongoing research initiatives and the deployment of innovative technologies by key players in the pharmaceutical industry are also boosting market growth. Significant government and private sector funding in Wilson's disease research further supports this trend[3].

Market Segmentation

The penicillamine market can be segmented in several ways:

By Drug Type

• Penicillamine is available in various forms, including capsules and tablets. The segmentation based on type helps in understanding the preferences and needs of different patient groups[4].

By Application

• The market is segmented based on application into hospitals, drug stores, and other healthcare facilities. Retail pharmacies have been the major revenue contributors due to the increasing number of independent pharmacies and chain stores[3][4].

By Distribution Channel

• The distribution channels include retail pharmacies, hospital pharmacies, and online pharmacies. Retail pharmacies dominate this segment due to the convenience and accessibility they offer to patients[3].

Regional Insights

The global penicillamine market is geographically diverse, but some regions stand out:

North America

• North America, particularly the United States, holds the largest share of the Wilson's disease drugs market, including penicillamine. Factors such as rising geriatric demand for long-term disease management and advancements in the field contribute to this dominance[3].

Other Regions

• Europe, Asia Pacific, Middle East and Africa, and South America also contribute to the market, though to a lesser extent. The growth in these regions is driven by increasing healthcare spending and government support for research and development[3].

Challenges and Restraints

Despite the growth, the penicillamine market faces several challenges:

Side Effects and Alternatives

• Penicillamine can have significant side effects, which may lead patients to opt for alternative treatments like trientine and zinc. The approval of new drugs by regulatory authorities can also shift market dynamics[3].

Lower Shelf Life

• The lower shelf life of penicillamine tablets can be a restraint, as it affects the supply chain and inventory management for pharmacies and healthcare providers[4].

Financial Trajectory

The financial trajectory of the penicillamine market is characterized by steady, though modest, growth.

• Revenue Forecast: The market is expected to grow from US$ 83 million in 2023 to US$ 91 million by 2030, with a CAGR of 1.3% during the forecast period[1][4].

• Investment and Funding: Significant investments in research and development, along with government and private sector funding, are crucial for sustaining this growth[3].

Key Players and Competitive Landscape

The competitive landscape of the penicillamine market includes several key players involved in the manufacture, distribution, and research of the drug.

• Research Initiatives: Companies are engaged in ongoing research to improve the efficacy and safety of penicillamine, as well as to develop new treatments for Wilson's disease[3].

• Strategic Collaborations: Strategic collaborations, such as the one between Biohaven Pharmaceutical Holding Company Ltd and Pfizer Inc., are also shaping the market by enhancing the commercialization and distribution of these drugs[3].

Conclusion

The penicillamine market, driven by increasing awareness, pharmaceutical demand, and research initiatives, is expected to continue its steady growth. However, it faces challenges such as side effects and the lower shelf life of the drug. Understanding these dynamics is crucial for stakeholders looking to navigate and capitalize on this market.

Key Takeaways

• The global penicillamine market was valued at US$ 83 million in 2023 and is expected to reach US$ 91 million by 2030.
• The market is growing at a CAGR of 1.3% during the forecast period of 2024-2030.
• Increasing awareness and diagnosis of Wilson's disease are key drivers.
• Retail pharmacies dominate the distribution channel segment.
• North America, particularly the United States, holds the largest market share.

Frequently Asked Questions

Q: What is the expected market size of the penicillamine market by 2030? A: The penicillamine market is expected to reach US$ 91 million by 2030[1][4].

Q: What is the CAGR of the penicillamine market during the forecast period? A: The penicillamine market is expected to grow at a CAGR of 1.3% during the forecast period of 2024-2030[1][4].

Q: What are the primary drivers of the penicillamine market? A: The primary drivers include increasing awareness and diagnosis of Wilson's disease, pharmaceutical demand, and ongoing research initiatives[3].

Q: Which region dominates the penicillamine market? A: North America, particularly the United States, holds the largest share of the penicillamine market[3].

Q: What are the challenges faced by the penicillamine market? A: The market faces challenges such as side effects, lower shelf life of the drug, and the availability of alternative treatments[3][4].

Cited Sources

1. Global Penicillamine Market Research Report 2024 - Valuates Reports
2. Penicillamine Market Report 2024 (Global Edition) - Cognitive Market Research
3. Wilson Disease Drugs Market: Global Industry Analysis and Forecast - Maximize Market Research
4. Penicillamine Market Size, Share, Trend, Global Research, 2031 - Business Research Insights
5. This report examines the demand for Penicillamine market, key vendors and key geographic areas from 2023 to 2030 - Prime PR Wire