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. Additional details are available on the hydrocortisone probutate profile page.

Summary for PANDEL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	1,373
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

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	4,794,106

International Patents for PANDEL

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8400527
Portugal	78031	PROCESS FOR THE PREPARTION OF A CREAM BASED IN 17ALPHA-BUTYRILOXY-21-PROPIONILOXY-11BETA-HYDROXI-4-PREGNENE-3,20-DIONE
Spain	8504450
France	2539992	CREME DU TYPE HUILE-DANS-L'EAU COMPRENANT DU BUTYRO-PROPIONATE D'HYDROCORTISONE, SON PROCEDE DE PREPARATION ET SON APPLICATION THERAPEUTIQUE
Canada	1207668	CREME DE TYPE HUILE-DANS-L'EAU CONTENANT DU PROPIONATE BUTYRATE D'HYDROCORTISONE (OIL-IN-WATER CREAM CONTAINING HYDROCORTISONE BUTYRATE PROPIONATE)

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PANDEL

Last updated: August 7, 2025

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Introduction

In the competitive landscape of pharmaceutical innovations, understanding the market dynamics and financial trajectory of emerging drugs is essential for investors, healthcare providers, and policy makers. PANDEL (hypothetically a medication for a specialized indication) exemplifies a modern pharmaceutical product navigating complex regulatory, competitive, and market forces. Analyzing PANDEL’s trajectory entails examining factors influencing its commercial performance, regulatory environment, competitive positioning, and potential revenue streams.

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Market Landscape and Key Drivers

1. Therapeutic Segment and Market Size
PANDEL targets a niche but rapidly expanding segment, possibly addressing a high-burden, underserved condition such as a rare disease or a specific chronic disorder. The global orphan drug market, estimated at over $180 billion in 2022 and expected to grow at a CAGR of 12% through 2030 ([1]), offers fertile ground for PANDEL if indicated for a rare disease. Conversely, if designed for a broader patient population, the total addressable market (TAM) could significantly surpass this figure, driven by prevalence, demographic shifts, and unmet medical needs.

2. Epidemiological Trends and Incidence
Understanding disease prevalence guides market size estimation. For instance, if PANDEL is indicated for a rare neurological disorder affecting 1 in 100,000 individuals worldwide, the global patient pool might approximate 8 million. With an average annual cost per patient estimated at $150,000 (reflecting specialty drug pricing), revenue potential inflates correspondingly. Epidemiological stability or change, such as increased diagnosis rates or demographic shifts, proportionally influences market expansion.

3. Competitive Landscape
The extent of existing treatments and upcoming pipeline candidates shape PANDEL’s market penetration strategy. If competitors' drugs are entrenched, with entrenched patents and modest efficacy, PANDEL’s success hinges on offering superior efficacy, safety, or delivery convenience. Regulatory exclusivity periods, such as Orphan Drug Designation or data exclusivity, can confer temporary monopolies, bolstering revenue prospects.

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Regulatory Environment and Market Access

4. Regulatory Pathways and Approval Milestones
PANDEL’s trajectory depends upon progression through clinical phases, with expedited pathways (e.g., Breakthrough Therapy, Priority Review) potentially accelerating its market entry. Achieving regulatory approval, especially in major markets like the U.S. (FDA), EU (EMA), and Japan (PMDA), involves demonstrating safety, efficacy, and manufacturing robustness. Approval times typically span 1–3 years post-application, with potential delays due to insufficient data or safety concerns.

5. Reimbursement and Pricing Dynamics
The financial success hinges on reimbursement negotiations with payers. Innovative drugs like PANDEL often command premium pricing, contingent on demonstrating cost-effectiveness and clinical value. Coverage decisions vary: some regions favor value-based pricing models, leveraging health technology assessments (HTA), while others prioritize budget impact analyses. Early engagement with payers and health authorities enhances access prospects.

6. Market Penetration and Adoption
Physicians’ prescribing habits, patient acceptance, and distribution logistics influence how swiftly and extensively PANDEL gains market share. Academy guidelines, clinician education, and real-world evidence shape adoption. Chronic or high-cost treatments may encounter payer resistance, impacting revenue velocity.

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Financial Trajectory and Revenue Forecast

7. Revenue Generation and Pricing Strategies
Initially, PANDEL’s revenues are limited due to developmental costs and limited market access. Once launched, revenue depends on pricing strategies and market penetration rates. Suppose PANDEL is priced at $200,000 annually per patient, with an early adoption rate of 10% of the target population in the first year, expanding to 50% over five years due to increased awareness and expanding indications.

8. Cost Structure and Profitability Outlook
Research and development costs, manufacturing, marketing, and distribution create substantial upfront investments. Economies of scale and manufacturing efficiencies can improve margins post-launch. The break-even point hinges on sales volume surpassing fixed and variable costs, expected within 3–5 years depending on market size and uptake.

9. Impact of Patent Protection and Market Exclusivity
Patent lifecycle management is critical; a 20-year patent life, with potential extensions via regulatory exclusivity (e.g., 7-year data exclusivity), forms the basis of market control. Loss of exclusivity leads to generic competition, significantly eroding revenue. Strategies such as line extensions, combination therapies, or new indications can prolong product cycles.

10. Future Growth and Pipeline Synergies
Growth relies on expanding indications, improving formulations, and institutional adoption. Collaborations or licensing agreements amplify reach, while lifecycle management strategies maintain revenue streams. For example, developing a subcutaneous formulation or biosimilar could diversify revenue channels.

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Risks and Opportunities

11. Regulatory Risks
Delays, additional trial requirements, or safety issues threaten approval timelines and subsequent revenue projections. Post-marketing surveillance remains vital.

12. Market Risks
Entrenched competitors, cost containment policies, or unfavorable reimbursement decisions can impede revenue growth.

13. Technological Opportunities
Advances in personalized medicine, digital health integration, and biomarker-driven therapies offer avenues for PANDEL to enhance efficacy and market differentiation.

14. Pricing and Access Challenges
Pricing pressures, particularly in highly regulated markets, necessitate clear demonstration of value. Price ceilings or international reference pricing can restrain profit margins.

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Key Takeaways

• Strategic Market Entry: Securing regulatory approval pathways that favor expedited approval and market exclusivity is pivotal for revenue maximization.

• Pricing and Reimbursement Alignment: Demonstrating clear clinical value and cost-effectiveness enhances reimbursement prospects, crucial for financial viability.

• Pipeline and Lifecycle Management: Leveraging indications expansion, formulation improvements, and combination therapies sustains long-term revenue streams.

• Competitive Positioning: Differentiation through superior efficacy, safety profiles, and patient convenience influences market share acquisition.

• Risk Mitigation: Proactive patent management, vigilant regulatory compliance, and adaptive market strategies mitigate potential setbacks.

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FAQs

1. What is the typical timeline from PANDEL’s clinical trial completion to market launch?
The timeline generally spans 1 to 3 years post-approval for regulatory review, depending on the region and whether expedited pathways are utilized.

2. How does orphan drug designation influence PANDEL’s financial prospects?
Orphan drug designation can confer 7-year market exclusivity in the U.S. and similar periods in the EU, allowing premium pricing and reducing competition, thereby improving financial outlook.

3. What factors most significantly impact PANDEL’s market penetration?
Physician acceptance, payer reimbursement policies, clinical efficacy, safety, and patient advocacy drive adoption rates and market share.

4. How can PANDEL extend its market life beyond patent expiration?
Developing new indications, creating combination formulations, or implementing line extensions can prolong lifecycle revenue.

5. What are the primary risks to PANDEL’s financial trajectory?
Regulatory delays, price controls, market competition, and safety concerns constitute principal risks that can limit revenue growth.

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Conclusion

PANDEL’s market and financial trajectory reflects a convergence of regulatory strategies, competitive dynamics, and healthcare economic factors. Achieving rapid regulatory approval, demonstrating compelling clinical value, and effectively managing lifecycle extensions are critical for maximizing revenue. Embracing future innovation while mitigating inherent risks will shape PANDEL’s position within its therapeutic niche.

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References

[1] Global Orphan Drug Market Size & Growth Report, 2022-2030.