Last updated: August 6, 2026
PLATINOL-AQ is the branded injectable formulation of cisplatin, a platinum-based oncology drug first approved in the United States in 1978. Its commercial value has shifted from branded product revenue to hospital procurement, generic supply, and shortage-driven purchasing. Bristol-Myers Squibb does not report PLATINOL-AQ revenue as a standalone product, and the brand’s original patent-based exclusivity has expired. Current economics are therefore determined by generic competition, manufacturing reliability, oncology demand, and institutional contracting rather than by brand pricing power.
What is PLATINOL-AQ and how is it used?
PLATINOL-AQ contains cisplatin, an alkylating-like platinum compound that forms DNA crosslinks. It is administered by intravenous infusion and is used across several oncology indications, including testicular, ovarian, bladder, head and neck, lung, cervical, esophageal, and other cancers under approved labeling and established clinical practice.[1]
What dosage forms and strengths does PLATINOL-AQ have?
The product is an aqueous cisplatin injection supplied at a concentration of 1 mg/mL. Historical U.S. presentations included:
| Presentation |
Cisplatin content |
Typical institutional use |
| 50 mL vial |
50 mg |
Individual or moderate-dose chemotherapy protocols |
| 100 mL vial |
100 mg |
Higher-dose regimens and hospital oncology use |
Cisplatin requires hydration, renal monitoring, electrolyte management, and antiemetic support. Its toxicity profile, particularly nephrotoxicity, ototoxicity, neurotoxicity, and myelosuppression, affects treatment selection and limits substitution with another platinum agent in some protocols.[1]
When did PLATINOL-AQ lose exclusivity?
PLATINOL-AQ lost meaningful U.S. exclusivity decades ago. The product was approved under Bristol-Myers Squibb’s NDA 018057, but cisplatin has been available from multiple generic manufacturers for many years. The market no longer depends on a single branded product for regulatory access or clinical supply.
What patents protect PLATINOL-AQ?
No commercially material, unexpired U.S. patent estate is generally associated with the original cisplatin active ingredient or the basic injectable formulation. The relevant exclusivity structure is:
| Protection type |
Current commercial relevance |
| Original active-ingredient patent |
Expired |
| Original product patent |
Expired or commercially immaterial |
| FDA regulatory exclusivity |
Expired |
| Basic cisplatin injection formulation patents |
Expired or not material to generic entry |
| Manufacturing process patents |
Potentially relevant to individual suppliers, but not a barrier to the established generic market |
| Method-of-use patents |
Limited value because cisplatin uses are longstanding and treatment protocols are well established |
The competitive question is not whether generic manufacturers can legally enter the cisplatin market. They already have. The relevant question is whether a supplier can maintain reliable production at commercially viable prices while meeting injectable manufacturing requirements.
What is the FDA regulatory status of PLATINOL-AQ?
PLATINOL-AQ was approved as an injectable cisplatin product under the FDA’s drug application framework. Cisplatin is a conventional small-molecule drug, not a biologic. It is therefore subject to abbreviated new drug application competition rather than biosimilar competition.
The FDA’s Drugs@FDA database and Orange Book distinguish between active and discontinued products and identify approved products, dosage forms, applicants, and marketing status.[2,3] The branded product’s regulatory position does not create a current barrier to generic cisplatin injection.
What is the Orange Book status of PLATINOL-AQ?
The Orange Book is relevant for identifying the original reference-listed drug and any patent or exclusivity listings. For an old genericized oncology injectable such as cisplatin, the commercial significance of Orange Book listings is low because:
- Original exclusivity has expired.
- Generic cisplatin products are established.
- There is no meaningful biosimilar pathway issue.
- Hospital buyers generally procure by active ingredient, concentration, supplier qualification, and availability.
Any current product status should be read directly from the FDA’s electronic Orange Book and Drugs@FDA databases because marketing status can change independently of clinical use.[2,3]
How many patents cover PLATINOL-AQ?
No material active patent portfolio is known to support a current branded monopoly for PLATINOL-AQ. The product’s historical patent position was associated with cisplatin and its original pharmaceutical development. Those rights have expired.
Are formulation patents important for cisplatin injection?
Formulation patents are not a meaningful source of market exclusivity for standard cisplatin injection. The formulation is an aqueous solution of cisplatin at an established concentration. Generic manufacturers can develop substantially equivalent products without reproducing a proprietary delivery platform.
Manufacturing know-how can still affect supply economics. Relevant operational barriers include:
- Control of platinum raw materials and chemical intermediates.
- Sterile filling and aseptic processing.
- Container compatibility and product stability.
- Prevention of contamination and particulate defects.
- Validation of compounding, packaging, and storage conditions.
- Compliance with current good manufacturing practices.
These factors can reduce the number of reliable suppliers even when legal entry is unrestricted.
Which companies compete with PLATINOL-AQ?
The U.S. cisplatin market includes generic injectable manufacturers and contract suppliers. Market participation has included companies such as Teva, Fresenius Kabi, Hikma, Accord Healthcare, and other approved or authorized suppliers, depending on product status and time period.[2,4]
Competition is fragmented but not fully commoditized in practical terms. Oncology hospitals often maintain preferred suppliers, yet shortages can force rapid substitution. Product availability may matter more than modest price differences.
How does PLATINOL-AQ compare with carboplatin and oxaliplatin?
| Attribute |
Cisplatin / PLATINOL-AQ |
Carboplatin |
Oxaliplatin |
| Drug class |
Platinum compound |
Platinum compound |
Platinum compound |
| Main commercial form |
IV injection |
IV injection |
IV injection |
| Relative renal toxicity |
Higher |
Lower than cisplatin |
Different toxicity profile |
| Hydration burden |
Significant |
Generally lower |
Lower in many protocols |
| Key use areas |
Broad solid-tumor use, including testicular, bladder, head and neck, lung |
Ovarian, lung and other solid tumors |
Colorectal and gastrointestinal cancers |
| Substitution |
Clinically constrained |
Not interchangeable in all protocols |
Not interchangeable in all protocols |
| Patent-based brand protection |
Expired |
Expired for established products |
Expired for established products |
| Market structure |
Generic and hospital-driven |
Generic and hospital-driven |
Generic and hospital-driven |
Cisplatin remains clinically important because efficacy, treatment protocols, and disease-specific evidence are not interchangeable with the other platinum agents. However, clinicians may select carboplatin or oxaliplatin where toxicity, tolerability, or regimen design favors those agents.[1]
What patent litigation and Paragraph IV risks affect PLATINOL-AQ?
Current Paragraph IV litigation risk is low. Paragraph IV certifications are most relevant when a generic applicant challenges an unexpired patent listed for a branded reference product. PLATINOL-AQ’s core exclusivity expired long ago, and cisplatin injection has an established generic market.
Potential disputes are more likely to concern:
- Manufacturing defects.
- Supply contracts.
- Product liability.
- Antitrust allegations involving shortages or allocation.
- Regulatory compliance.
- Hospital purchasing and distribution arrangements.
A new cisplatin formulation, delivery system, or combination product could create a separate patent strategy. Such rights would protect the new product, not the conventional PLATINOL-AQ formulation.
When did cisplatin shortages affect the market?
Cisplatin has experienced recurring supply disruptions. FDA drug-shortage records have identified cisplatin injection shortages associated with manufacturing constraints, increased demand, raw-material limitations, and production interruptions.[4]
Shortages change the market in four ways:
- Hospitals accept higher-cost substitute suppliers.
- Distributors allocate inventory based on institutional priority.
- Manufacturers with available supply gain temporary negotiating leverage.
- Clinicians may use carboplatin or alter treatment timing where medically appropriate.
Shortages do not restore patent exclusivity. They create temporary supply power within a structurally generic market.
What manufacturing barriers affect PLATINOL-AQ supply?
Sterile injectable manufacturing is the main barrier. Cisplatin is inexpensive as an active ingredient relative to the cost of maintaining validated sterile production, quality systems, regulatory compliance, and inventory capacity. Low unit pricing can discourage redundant manufacturing capacity.
This creates a market with low legal entry barriers but higher operational barriers. A supplier may have an approved product and still lack the capacity to respond to a sudden increase in hospital demand.
What is the financial trajectory of PLATINOL-AQ?
PLATINOL-AQ’s financial trajectory is consistent with an old oncology brand:
| Period |
Financial condition |
| Initial launch and early adoption |
Branded pricing supported development recovery and clinical adoption |
| Generic entry |
Price erosion and loss of share |
| Mature generic market |
Low unit prices, institutional purchasing, and limited brand premium |
| Shortage periods |
Temporary pricing and volume gains for available suppliers |
| Long-term outlook |
Stable clinical demand but limited brand-driven revenue growth |
Bristol-Myers Squibb’s public financial reporting does not identify PLATINOL-AQ as a separately reported revenue line. The company reports at broader product or business-segment levels, so a defensible standalone revenue series cannot be derived from public annual reports.[5]
What is the revenue exposure for the brand owner?
Direct revenue exposure for the original brand owner is likely limited relative to the company’s major oncology products. PLATINOL-AQ is an established, genericized injectable with no current patent premium. Its commercial value is more likely tied to legacy product sales, supply arrangements, or portfolio continuity than to material growth.
The broader cisplatin market remains financially relevant to manufacturers because the drug is clinically entrenched and purchased in high-volume hospital channels. The value accrues to suppliers that can produce consistently, maintain regulatory compliance, and secure distribution access.
What generic launch scenarios exist for PLATINOL-AQ?
Base case: stable generic supply
In the base case, multiple suppliers remain active, hospital buyers continue to tender on price and reliability, and cisplatin demand tracks oncology procedure volumes. Revenue remains modest and margins remain constrained.
Upside case: shortage-driven share capture
A manufacturer with available inventory can capture temporary share during a competitor shutdown or allocation event. The gain depends on shortage duration, FDA supply conditions, hospital qualification requirements, and distributor access. It is usually a volume opportunity rather than a durable branded franchise.
Downside case: further price compression
Additional suppliers or aggressive contracting can push prices lower. The risk is highest for manufacturers with small scale, high compliance costs, or limited purchasing leverage. Very low prices may reduce supplier participation and increase future shortage risk.
Innovation case: differentiated delivery
A premixed, stability-enhanced, ready-to-administer, or lower-toxicity platinum product could support new patents and higher pricing. Conventional cisplatin injection does not provide that protection. Any commercial opportunity would depend on clinical differentiation and FDA approval of the new product.
How strong is the PLATINOL-AQ patent estate?
The patent estate is weak for current commercial protection. The strength profile is:
| Factor |
Assessment |
| Active-ingredient protection |
None of practical commercial significance |
| Formulation protection |
Weak for conventional aqueous injection |
| Method-of-use protection |
Limited due to longstanding clinical uses |
| Generic entry barriers |
Low legally; moderate operationally |
| Litigation leverage |
Low |
| Supply-chain leverage |
Intermittent and potentially meaningful during shortages |
| Long-term revenue protection |
Low |
The commercial moat is supply execution, not intellectual property.
Key Takeaways
- PLATINOL-AQ is the historical branded cisplatin injection associated with Bristol-Myers Squibb.
- Cisplatin was approved in the United States in 1978 and has been genericized for decades.
- Original patent and FDA exclusivity protections no longer support a branded monopoly.
- No biosimilar risk applies because cisplatin is a small-molecule drug.
- The main competitive barriers are sterile manufacturing, quality compliance, and reliable distribution.
- Recurring cisplatin shortages can create temporary share and pricing advantages for available suppliers.
- Bristol-Myers Squibb does not publicly disclose standalone PLATINOL-AQ revenue.
- Long-term financial value is limited as a branded asset but remains relevant to generic injectable manufacturers and hospital procurement channels.
- Paragraph IV litigation risk is low for conventional cisplatin injection.
- Any new commercial opportunity would likely require a differentiated formulation, delivery system, or combination product.
FAQs
Is PLATINOL-AQ still commercially available in the United States?
Cisplatin injection remains an established U.S. oncology product, but the availability of the specific PLATINOL-AQ brand should be determined from current FDA product records and distributor listings. Generic cisplatin products are the primary commercial supply source.
Is PLATINOL-AQ interchangeable with carboplatin?
No. Both are platinum agents, but they have different dosing, toxicity, pharmacology, and clinical use profiles. Treatment substitution requires an oncology decision and is not an automatic pharmaceutical substitution.
Does PLATINOL-AQ have pediatric exclusivity?
No current pediatric exclusivity is associated with the mature cisplatin product. Any original regulatory exclusivity would have expired long ago.
Can a company obtain new patents for cisplatin?
Yes, but a new patent would need to cover a novel and non-obvious formulation, delivery method, manufacturing process, combination, or clinical use. It would not revive exclusivity for conventional cisplatin injection.
Is cisplatin financially attractive for generic manufacturers?
It can be attractive when supply is constrained or when a manufacturer has efficient sterile production and reliable hospital distribution. Outside shortage periods, low prices and purchasing pressure limit margins.
References
-
National Library of Medicine. (2024). DailyMed: Cisplatin injection prescribing information. https://dailymed.nlm.nih.gov/dailymed/
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U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
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U.S. Food and Drug Administration. (2024). FDA drug shortages: Cisplatin injection. https://www.accessdata.fda.gov/scripts/drugshortages/
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Bristol-Myers Squibb Company. (Various years). Annual reports and Form 10-K filings. U.S. Securities and Exchange Commission. https://www.sec.gov/edgar/searchedgar/companysearch.html
