PANDEL Drug Patent Profile

Which patents cover Pandel, and what generic alternatives are available?

Pandel is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in PANDEL is hydrocortisone probutate. There are sixty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrocortisone probutate profile page.

Summary for PANDEL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	1
Patent Applications:	1,169
Drug Prices:	Drug price information for PANDEL
What excipients (inactive ingredients) are in PANDEL?	PANDEL excipients list
DailyMed Link:	PANDEL at DailyMed

See drug prices for PANDEL

Recent Clinical Trials for PANDEL

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

Sponsor	Phase
Fougera Pharmaceuticals Inc.	Phase 4

See all PANDEL clinical trials

Pharmacology for PANDEL

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for PANDEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997		DISCN	Yes	No

Expired US Patents for PANDEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997

International Patents for PANDEL

See the table below for patents covering PANDEL around the world.

Country	Patent Number	Title	Estimated Expiration
France	2539992	CREME DU TYPE HUILE-DANS-L'EAU COMPRENANT DU BUTYRO-PROPIONATE D'HYDROCORTISONE, SON PROCEDE DE PREPARATION ET SON APPLICATION THERAPEUTIQUE
Portugal	78031	PROCESS FOR THE PREPARTION OF A CREAM BASED IN 17ALPHA-BUTYRILOXY-21-PROPIONILOXY-11BETA-HYDROXI-4-PREGNENE-3,20-DIONE
Canada	1207668	CREME DE TYPE HUILE-DANS-L'EAU CONTENANT DU PROPIONATE BUTYRATE D'HYDROCORTISONE (OIL-IN-WATER CREAM CONTAINING HYDROCORTISONE BUTYRATE PROPIONATE)
Spain	529278
South Africa	8400527
United Kingdom	8402025

Supplementary Protection Certificates for PANDEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112

PANDEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pharmaceutical Drugs: A Comprehensive Overview

Introduction to Pharmaceutical Drug Market Dynamics

The pharmaceutical drug market is a complex and dynamic sector, influenced by a myriad of factors including technological advancements, demographic changes, regulatory environments, and economic conditions. Here, we will delve into the key market dynamics and financial trajectories that shape the industry.

Global Market Growth Outlook

The global pharmaceutical drug delivery market is projected to experience significant growth, transitioning from USD 1,949.4 billion in 2024 to USD 2,546.0 billion by 2029, with a Compound Annual Growth Rate (CAGR) of 5.5%[1].

Drivers of Market Growth

Several factors are driving this growth:

• Increasing Incidence of Chronic Diseases: The rising global incidence of chronic diseases such as diabetes, hypertension, cancer, and infectious diseases is a major driver.
• Launch of New Products: Continuous innovation and the launch of new pharmaceutical products contribute to market expansion.
• R&D Investments: Increased investment in pharmaceutical research and development (R&D) is crucial for the development of new therapies.
• Patient Comfort and Compliance: Emphasis on patient comfort and compliance, particularly through self-administration and home care trends, is another significant factor.
• Government Initiatives: Government initiatives to provide affordable drug delivery products and supportive reimbursement policies also play a vital role[1].

Impact of Demographic Changes

Aging Population

The growing geriatric population is a key demographic factor influencing the pharmaceutical market. Older populations are more prone to chronic conditions, which increases the demand for pharmaceuticals. For instance, the pain management drugs market is driven by an aging global population prone to chronic conditions[4].

Rising Prevalence of Diseases

The rising prevalence of diseases such as Parkinson's, cancer, and other chronic conditions also drives market growth. The Parkinson's disease drug market, for example, is expected to grow from USD 4.61 billion in 2023 to USD 11.98 billion by 2031, with a CAGR of 12.1%[3].

Technological Advancements

Modernization of Drug Delivery Technologies

Advancements in drug delivery technologies are transforming the market. Innovations such as oral administration routes, which are more patient-friendly, and minimally invasive procedures are gaining traction. For instance, the oral route of administration dominates the Parkinson's disease drug market due to factors like patient compliance and convenience[3].

Innovative Formulations

Technological advancements in formulations, such as the development of new molecules and delivery systems, are also driving market growth. The pain management drugs market, for example, benefits from innovative pain therapies and advanced drug delivery systems[4].

Financial Performance and Projections

Revenue Growth

Companies in the pharmaceutical sector are experiencing significant revenue growth. For instance, Servier Group's consolidated revenue increased by 9.2% to €5.327 billion in the 2022-2023 financial year, driven by growth in brand-name and generic medicines[2].

EBITDA and Profit Margins

The financial performance of pharmaceutical companies is also reflected in their EBITDA and profit margins. Servier Group's EBITDA stood at €1.015 billion with a margin of 19.1% in the 2022-2023 financial year, indicating strong financial health[2].

Regional Performance

Regional performance varies, with significant growth seen in international markets. For Servier, international revenue accounted for 56.6% of consolidated revenue, with the US subsidiary being the leading entity[2].

Market Segments and Distribution Channels

Distribution Channels

The distribution channels for pharmaceutical drugs are evolving. Hospital pharmacies currently dominate the market, especially for diseases like Parkinson's, due to the availability of diagnostic laboratories and qualified neurologists[3].

Market Segments

Different market segments, such as brand-name, generic, and specialty drugs, operate differently and have distinct growth trajectories. The generic market, for instance, has seen diminishing profits due to government price caps and fewer new generics entering the market[5].

Regulatory and Healthcare Reforms

Government Initiatives

Government initiatives and regulatory reforms significantly impact the pharmaceutical market. For example, supportive reimbursement policies and healthcare reforms like the U.S. Patient Protection and Affordable Care Act of 2010 contribute to market growth[4].

Access and Affordability

Regulatory environments also affect access and affordability. In emerging economies, rapid urbanization and improving healthcare infrastructure enhance access to pharmaceuticals, although challenges like limited healthcare access in rural areas and affordability issues persist[4].

Challenges and Opportunities

Challenges

The pharmaceutical industry faces several challenges, including patent expirations, regulatory hurdles, and affordability issues. The return on generic profits has diminished, and retail pharmacies have seen significant decreases in profitability[5].

Opportunities

Despite these challenges, there are lucrative opportunities. The patent expiration of branded pharmaceuticals and a robust drug pipeline offer growth prospects. Additionally, increasing healthcare expenditure and government initiatives to improve healthcare services are expected to propel market growth[3][4].

Expert Insights and Statistics

Expert Views

Industry experts emphasize the need for adaptability in the face of changing market dynamics. For example, Bill Roth from the Blue Fin Group highlights the importance of preparing for new distribution channels and business models that are disrupting traditional pharmacy industry practices[5].

Illustrative Statistics

• The global pain management drugs market is projected to reach $109.6 billion by 2033, growing at a CAGR of 4.2% from 2024 to 2033[4].
• The Parkinson's disease drug market is expected to grow from USD 4.61 billion in 2023 to USD 11.98 billion by 2031, with a CAGR of 12.1%[3].

Key Takeaways

• The global pharmaceutical drug delivery market is expected to grow significantly, driven by chronic disease incidence, R&D investments, and patient comfort.
• Technological advancements in drug delivery and formulations are key drivers.
• Demographic changes, such as an aging population, significantly impact market dynamics.
• Financial performance is strong, with companies like Servier experiencing substantial revenue and EBITDA growth.
• Regulatory and healthcare reforms play a crucial role in shaping market access and affordability.
• Despite challenges, the industry offers numerous opportunities driven by patent expirations and robust drug pipelines.

Frequently Asked Questions (FAQs)

1. What is the projected growth rate of the global pharmaceutical drug delivery market?

The global pharmaceutical drug delivery market is forecasted to grow at a CAGR of 5.5% from 2024 to 2029[1].

2. Which demographic factor is significantly influencing the pharmaceutical market?

The growing geriatric population is a key demographic factor driving the demand for pharmaceuticals due to their increased susceptibility to chronic conditions[4].

3. How are technological advancements impacting the pharmaceutical market?

Technological advancements in drug delivery technologies and formulations are transforming the market by offering more patient-friendly and effective treatment options[3][4].

4. What are the major distribution channels for pharmaceutical drugs?

Hospital pharmacies currently dominate the market, especially for diseases like Parkinson's, due to the availability of diagnostic laboratories and qualified neurologists[3].

5. How do government initiatives impact the pharmaceutical market?

Government initiatives and regulatory reforms significantly impact the market by providing supportive reimbursement policies, improving access to healthcare, and influencing affordability[4].

Cited Sources:

1. MarketsandMarkets, Pharmaceutical Drug Delivery Market Growth, Drivers & Opportunities.
2. Servier, Servier confirms its 2025 trajectory to achieve its 2030 ambition.
3. SkyQuestT, Parkinson's Disease Drug Market Size, Share, Trends & Forecast.
4. Allied Market Research, Pain Management Drugs Market Size, Share | Forecast - 2033.
5. ASHP, Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs.