PLATINOL-AQ Drug Patent Profile

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

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

The generic ingredient in PLATINOL-AQ 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-aq

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

Summary for PLATINOL-AQ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	343
DailyMed Link:	PLATINOL-AQ at DailyMed

Recent Clinical Trials for PLATINOL-AQ

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-AQ clinical trials

Pharmacology for PLATINOL-AQ

Drug Class

Platinum-based Drug

US Patents and Regulatory Information for PLATINOL-AQ

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-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984		DISCN	Yes	No

Expired US Patents for PLATINOL-AQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984	4,177,263
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984	5,562,925
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984	4,310,515

International Patents for PLATINOL-AQ

See the table below for patents covering PLATINOL-AQ 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
Switzerland	619141
Argentina	218134	PROCEDIMIENTO PARA LA PREPARACION DE UNA SOLUCION ACUOSA,ESTERIL Y ESTABLE,DE CISPLATINA
Hong Kong	37982	PHARMACEUTICAL FORMULATIONS CONTAINING CIS-PLATINUM (II) DIAMMINEDICHLORIDE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PLATINOL-AQ

Last updated: July 30, 2025

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Introduction

PLATINOL-AQ (cisplatin injection) stands as a cornerstone chemotherapeutic agent, primarily employed in the treatment of various cancers, including ovarian, lung, bladder, and testicular cancers. Its global market dynamics are shaped by evolving oncological treatment paradigms, regulatory landscapes, manufacturing considerations, and emerging competition. This analysis dissects PLATINOL-AQ’s current market position, delineates key drivers impacting its financial trajectory, and forecasts future trends within this specialized pharmaceutical segment.

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Overview of PLATINOL-AQ

Developed and marketed by pharmaceutical giants, PLATINOL-AQ is an aqueous complex of cisplatin, a platinum-based chemotherapeutic agent approved by authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It has enjoyed decades of clinical use due to its proven efficacy, cost viability, and established manufacturing processes. Innovations aimed at enhancing formulation stability and patient tolerability have been incremental, but the core molecule remains unchanged.

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Market Dynamics

1. Oncology Treatment Landscape and Clinical Adoption

Cancer treatment increasingly embraces targeted therapies and immuno-oncology, which challenge the dominance of traditional chemotherapeutics like cisplatin. Nonetheless, PLATINOL-AQ remains integral, frequently used as a first-line agent due to its broad-spectrum activity and established benefit-risk profile. Its role persists especially in developing markets, where cost considerations favor traditional chemotherapeutics over expensive biologics.

The clinical adoption of PLATINOL-AQ is influenced by evolving treatment guidelines. For example, recent updates to NCCN and ESMO guidelines continue to endorse cisplatin-based regimens for specific cancer types, though with increasing consideration of alternative agents in cases of resistance or adverse effects.

2. Competition from Alternative Platinum Compounds

Second-generation platinum agents, such as carboplatin and oxaliplatin, offer comparable efficacy with differing toxicity profiles, impacting PLATINOL-AQ’s market share. Carboplatin, in particular, has gained preference due to its ease of administration and reduced nephrotoxicity, gradually encroaching on PLATINOL-AQ’s territory in some indications.

3. Regulatory and Patent Landscapes

Although PLATINOL-AQ’s primary patents have expired, regulatory exclusivities and manufacturing patents still influence market dynamics. Generic versions have entered various markets, intensifying price competition and affecting profitability. Patent expirations, particularly in key regions like North America and Europe, have facilitated price reductions and increased market penetration.

4. Manufacturing and Supply Chain Considerations

Cisplatin’s complex synthesis and stability issues require specialized manufacturing facilities, impacting costs and supply reliability. The advent of biosimilar-like generic formulations has spurred efforts to optimize production, but capacity constraints and quality control remain barriers to rapid market expansion.

5. Geographical Market Trends

• United States and Europe: Mature markets characterized by high drug penetration, strict regulatory standards, and increasing shift toward personalized medicine. Though price pressures exist, PLATINOL-AQ remains relevant owing to longstanding clinical familiarity.
• Emerging Markets: Rapidly growing markets, especially in Asia and Latin America, where affordability and manufacturing capacity favor older chemotherapies. Despite competition from generics, market growth is robust, driven by rising cancer incidence and healthcare infrastructure improvement.

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Financial Trajectory

1. Revenue Trends and Market Size

The global cisplatin market was valued at approximately USD 300 million in 2022 with a CAGR of around 5% projected through 2030 [1]. PLATINOL-AQ’s share is influenced by drug aging, competition, and regional dynamics.

In mature markets, revenues plateau or decline marginally due to generic erosion, but in emerging markets, revenues are projected to grow, propelled by increasing cancer prevalence and improved healthcare access.

2. Pricing Dynamics and Cost-Containment Strategies

Pricing pressures owing to generics and healthcare reforms necessitate strategic pricing and value demonstration. Institutions favor lower-cost generic formulations, often compelling branded manufacturers to implement cost-reduction strategies. The net effect presses margins, particularly in highly competitive territories.

3. Regulatory Impact on Investment and Innovation

Authorized uses and indications significantly affect revenue streams. Expansion into new indications is limited due to high regulatory costs, whereas existing approvals sustain baseline revenues. Limited innovation within cisplatin formulations constrains growth potential, emphasizing the importance of lifecycle management and adjunct therapy development.

4. Impact of Therapeutic Alternatives

The advent of immunotherapies, such as checkpoint inhibitors (e.g., pembrolizumab), has shifted treatment standards for certain cancers, marginally reducing reliance on traditional agents, including PLATINOL-AQ. Although cisplatin remains a backbone in some regimens, the competitive landscape portends a gradual decline in its share, unless combination therapies or novel formulations enhance its efficacy.

5. Future Financial Outlook

Forecasts suggest moderate revenue growth in developing markets, offset by stagnation or decline in mature regions. The overall global market could see a CAGR of approximately 3-4% over the next decade, with the potential for localized surges driven by policy shifts and cancer incidence rates [2].

Innovation, such as nanoparticle delivery systems or combination therapies, may rejuvenate PLATINOL-AQ’s market prospects, provided these strategies demonstrate substantial clinical benefits that justify investment.

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Key Market Drivers

• Growing global cancer burden, especially lung, ovarian, and bladder cancers.
• Cost-effectiveness and established clinical profile of cisplatin.
• Ongoing generic competition lowering prices and expanding access.
• Regional healthcare infrastructure improvements fostering market penetration.
• Potential for novel formulations and combination regimens to sustain relevance.

Key Market Challenges

• Shift toward targeted and immune therapies, reducing reliance on traditional chemotherapeutics.
• Toxicity profiles limiting cisplatin’s applicability, especially nephrotoxicity and ototoxicity.
• Patent expirations and price erosion impacting profitability.
• Emerging competition from biosimilars and generics.
• Regulatory hurdles in expanding indications or obtaining new approvals.

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Conclusion

PLATINOL-AQ occupies a transitional space in the oncology pharmacopeia. Its enduring presence stems from proven efficacy, cost advantages, and clinical familiarity, particularly in developing markets. However, evolving treatment guidelines, competition, and technological innovations are reshaping its financial landscape. The trajectory suggests steady mature-market decline complemented by growth opportunities in emerging markets and potential rejuvenation through formulation innovations.

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Key Takeaways

• Market maturity and competition are dampening PLATINOL-AQ’s growth prospects in established regions, emphasizing the importance of cost management and lifecycle strategies.
• Emerging markets present significant upside, driven by rising cancer incidence and healthcare infrastructure development.
• Innovation opportunities, such as combination regimens or delivery formulations, are critical to extending PLATINOL-AQ’s relevance.
• Regulatory and patent landscapes will continue to influence pricing, market access, and competitive positioning.
• Strategic positioning within integrated oncology treatment frameworks will determine long-term financial outcomes for PLATINOL-AQ.

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FAQs

Q1: What factors are primarily affecting PLATINOL-AQ’s market share?
A: Competition from carboplatin and oxaliplatin, regulatory expirations leading to generics, shifting treatment paradigms toward targeted and immunotherapies, and toxicity profile limitations are primary factors influencing its market share.

Q2: How are emerging markets impacting the future of PLATINOL-AQ?
A: Emerging markets exhibit rising cancer prevalence, improving healthcare infrastructure, and affordability factors favoring older chemotherapies like cisplatin. This demographic trend sustains demand and offers growth opportunities.

Q3: What role do innovations and formulations play in PLATINOL-AQ’s trajectory?
A: Novel formulations and combination therapies could restore or enhance its utility, overcoming toxicity issues and expanding indications, thus positively influencing its financial outlook.

Q4: How might regulatory changes influence PLATINOL-AQ’s revenue?
A: Regulatory approvals, restrictions on indications, and patent status will impact market access, pricing, and competitiveness, directly affecting revenues.

Q5: What strategies can manufacturers adopt to sustain profitability?
A: Strategies include cost-efficiency in manufacturing, expanding into new or underserved markets, developing adjunct therapies, and innovating formulations to improve tolerability and efficacy.

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References

[1] Market Research Future. "Global Cisplatin Market Analysis." 2022.

[2] Grand View Research. "Oncology Drugs Market Size, Share & Trends." 2023.