PLATINOL Drug Patent Profile

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

Platinol is a drug marketed by Hq Spclt Pharma and is included in one NDA.

The generic ingredient in PLATINOL is cisplatin. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Platinol

A generic version of PLATINOL was approved as cisplatin by PHARMACHEMIE BV on May 16^th, 2000.

Summary for PLATINOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	343
DailyMed Link:	PLATINOL at DailyMed

Recent Clinical Trials for PLATINOL

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
AstraZeneca	Phase 3
Wuhan Union Hospital, China	Phase 2

See all PLATINOL clinical trials

Pharmacology for PLATINOL

Drug Class

Platinum-based Drug

US Patents and Regulatory Information for PLATINOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984		DISCN	Yes	No

Expired US Patents for PLATINOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982	4,177,263
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982	5,562,925

International Patents for PLATINOL

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

Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	142293	VERFAHREN ZUR HERSTELLUNG EINES PHARMAZEUTISCHEN MITTELS
Hungary	177557	PROCESS FOR PREPARING STABLE AEQUOUS STERILE SOLUTION OF CYS-PLATINIC/II/-DIAMINE-DICHLORIDE
New Zealand	189556	STABILISED AQUEOUS SOLUTIONS OF CISPLATIN

Market Dynamics and Financial Trajectory of PLATINOL (cisplatin)

Last updated: July 30, 2025

Introduction

PLATINOL, the brand designation for cisplatin, remains one of the most historically significant chemotherapeutic agents used in oncology. Approved in the 1970s, cisplatin revolutionized cancer treatment, particularly for testicular, ovarian, lung, and bladder cancers. Despite the emergence of newer compounds, PLATINOL's market presence persists due to its established efficacy, cost-effectiveness, and regulatory approvals. This analysis explores current market dynamics and projects the financial trajectory of PLATINOL amidst evolving oncology therapeutics.

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Market Overview and Current Position

Cisplatin (PLATINOL) maintains a substantial role in oncology, particularly in regimes where it demonstrates superior survival outcomes. Its generic status, following patent expiration, has facilitated widespread adoption and affordability, especially in low- and middle-income countries (LMICs). According to IQVIA data, cisplatin's global sales in 2022 exceeded $400 million, reflecting its enduring clinical relevance[1].

However, newer platinum-based agents like carboplatin and oxaliplatin have expanded therapeutic options, often with improved safety profiles. This transition has slightly diminished PLATINOL's market share in some regions but not diminished its core role in protocols requiring cisplatin's specific benefits, such as its unique DNA-binding properties and higher potency in certain cancers.

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Market Drivers

1. Established Efficacy and Clinical Guidelines

   PLATINOL remains a standard of care in multiple clinical guidelines, including NCCN and ESMO, especially in first-line regimens for testicular and ovarian cancers. Its proven track record sustains demand, particularly in settings where cost is a major consideration.

2. Global Oncology Burden

   With a rising incidence of cancers treatable with cisplatin (e.g., lung, head and neck, cervical), demand is projected to remain stable or grow modestly. The WHO estimates that cancer cases are increasing globally, notably in LMICs where access to cost-effective chemotherapy remains critical[2].

3. Patent Status and Generic Competition

   The expiration of patents has fueled competition among generic manufacturers, broadening access and driving prices downward but maintaining volume-based revenues for producers (e.g., Teva, Sun Pharmaceutical).

4. Regulatory Approvals and Expanded Indications

   Ongoing clinical trials exploring cisplatin in new therapeutic contexts or combination therapies could extend its market lifespan. Additionally, regulatory approvals in emerging markets bolster regional sales.

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Market Challenges

1. Toxicity Profile and Safety Concerns

   Cisplatin's significant side effects, including nephrotoxicity, ototoxicity, and neurotoxicity, have prompted clinicians to prefer alternatives like carboplatin in certain settings, impacting overall volume growth.

2. Emergence of Targeted and Immunotherapies

   The advent of targeted agents and immune checkpoint inhibitors has shifted the treatment landscape. For example, in non-small cell lung cancer (NSCLC), immunotherapies often supplant platinum-based chemotherapy alone, potentially reducing cisplatin's usage.

3. Manufacturing and Supply Chain Considerations

   Production complexity, supply chain disruptions (notably during COVID-19), and raw material constraints affect availability and pricing stability.

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Financial Trajectory and Forecast

Short-term Outlook (Next 2-3 Years):

Post-pandemic recovery is expected to stabilize demand, supported by ongoing treatments in oncology centers globally. The generic market is highly competitive, exerting downward pressure on prices, but steady procurement volumes ensure sustained revenue streams for established manufacturers. Regional disparities will persist, with LMICs increasingly relying on affordable, generic cisplatin.

Medium to Long-term Outlook (3-10 Years):

• Market Maturation and Potential Decline: As personalized medicine advances, the share of cisplatin in combination regimens may diminish in favor of precision therapies, especially in high-income countries.

• Market Stabilization in Certain Indications: Diseases like testicular cancer, where cisplatin remains foundational, will preserve demand.

• Innovation and New Formulations: Slight innovations, such as nanoparticle delivery systems to mitigate toxicity, could rejuvenate interest and expand indications.

• Pricing and Reimbursement Trends: Governments and payers' emphasis on affordability suggest continued price pressures, especially as biosimilars and generics mature.

• Regional Growth: Increased access in LMICs promises volume growth outpacing value erosion, maintaining PLATINOL's significance.

Projected Market Value (2023-2033):

Based on current data, the global cisplatin market could grow at an annual compound growth rate (CAGR) of around 3-4%, primarily driven by emerging markets. The market valuation may plateau or decline marginally (~2% CAGR) as newer therapies gain favor in developed markets yet sustain a niche role in global chemotherapy protocols.

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Competitive Landscape

While multiple generic manufacturers distribute cisplatin, few proprietary entrants compete due to the drug’s generic nature. The primary competition comes from carboplatin and oxaliplatin, which have captured market segments through better tolerability. Major generic players include:

• Teva Pharmaceuticals
• Sandoz (Novartis)
• Sun Pharmaceutical Industries
• Mylan (now part of Viatris)

Supply chain robustness, manufacturing quality, and regional regulatory approvals influence market shares.

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Regulatory and Intellectual Property Considerations

Cisplatin patents have long expired, enabling widespread generic manufacture. Regulatory agencies, including the FDA and EMA, maintain rigorous standards, ensuring safety and efficacy but presenting limited barriers to market entry. Ongoing patent litigations or exclusivity for specific formulations are unlikely, allowing supply to remain competitive.

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Conclusion

PLATINOL retains a stable, if gradually declining, market due to its clinical efficacy, affordability, and global oncology needs. Its financial trajectory hinges on regional demand dynamics, evolving treatment standards, and innovations in formulation or combination strategies. While targeted therapies and immunotherapies are reshaping oncology, cisplatin’s role in combination regimens and in resource-constrained settings sustains its relevance.

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Key Takeaways

• Stable Core Role: Despite competition, PLATINOL remains a critical chemotherapy agent, especially for specific indications like testicular and ovarian cancers.

• Market Growth Driven by Global Cancer Burden: Increasing cancer prevalence worldwide, particularly in LMICs, sustains demand for cost-effective chemotherapeutics like cisplatin.

• Pricing Pressure and Competition: Generic proliferation drives prices downward but ensures steady-volume revenues, with supply chain resilience being critical.

• Emerging Therapeutic Paradigms: Advances in targeted therapy and immunotherapy may eventually curtail cisplatin’s usage in some indications, potentially leading to a gradual decline.

• Regional Dynamics: Developing markets will likely see increased cisplatin adoption due to affordability, securing long-term revenues.

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FAQs

1. What determines PLATINOL's continued market relevance despite new therapies?
   Its proven efficacy, affordability, and status as a standard treatment in key indications sustain demand, especially where healthcare budgets are constrained.

2. How does the expiration of patents impact PLATINOL?
   Patent expiry facilitates widespread generic manufacturing, increasing access and reducing prices, thus maintaining high volume sales.

3. What factors could threaten PLATINOL’s market position?
   Advances in targeted therapies, better tolerability chemotherapies, and personalized medicine approaches could reduce its usage in certain cancers.

4. Are there ongoing innovations or formulations to extend PLATINOL's market life?
   Research into nanoparticle delivery systems and toxicity mitigation strategies may enhance its therapeutic profile, potentially revitalizing its role.

5. How significant is PLATINOL’s role in emerging markets?
   Very significant; cost-effectiveness and established clinical protocols ensure wide adoption, making these markets vital for future revenue streams.

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References

[1] IQVIA. (2022). Global Oncology Market Data.
[2] World Health Organization. (2021). Global Cancer Incidence and Mortality.