CERUBIDINE Drug Patent Profile

When do Cerubidine patents expire, and what generic alternatives are available?

Cerubidine is a drug marketed by Hikma, Sanofi Aventis Us, and Wyeth Ayerst. and is included in three NDAs.

The generic ingredient in CERUBIDINE is daunorubicin hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cerubidine

A generic version of CERUBIDINE was approved as daunorubicin hydrochloride by HIKMA on January 30^th, 1998.

Summary for CERUBIDINE

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	70
DailyMed Link:	CERUBIDINE at DailyMed

Recent Clinical Trials for CERUBIDINE

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
PrECOG, LLC.	Phase 2
Astellas Pharma Inc	Phase 2

See all CERUBIDINE clinical trials

US Patents and Regulatory Information for CERUBIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	CERUBIDINE	daunorubicin hydrochloride	INJECTABLE;INJECTION	064103-001	Feb 3, 1995	AP	RX	No	Yes
Sanofi Aventis Us	CERUBIDINE	daunorubicin hydrochloride	INJECTABLE;INJECTION	061876-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	CERUBIDINE	daunorubicin hydrochloride	INJECTABLE;INJECTION	050484-001	Approved Prior to Jan 1, 1982		DISCN	No	No

CERUBIDINE Market Dynamics, Patent Status, and Financial Trajectory

Last updated: August 12, 2026

CERUBIDINE is the branded injectable form of daunorubicin hydrochloride, an anthracycline used primarily in combination chemotherapy for acute myeloid leukemia and acute lymphoblastic leukemia. Its commercial profile is that of a mature hospital generic molecule rather than an actively protected branded drug. Revenue is driven by protocol-based demand, hospital purchasing, generic availability, sterile-injectable manufacturing capacity, and periodic shortages. Sanofi does not publicly report standalone CERUBIDINE revenue, so the product’s financial trajectory must be assessed through market structure and utilization rather than brand-level sales data.

What is CERUBIDINE and who markets it?

CERUBIDINE contains daunorubicin hydrochloride, an anthracycline that inhibits topoisomerase II and interferes with DNA and RNA synthesis. The FDA label covers combination use in acute nonlymphocytic leukemia and acute lymphocytic leukemia, subject to regimen-specific dosing and safety restrictions.[1]

Attribute	CERUBIDINE profile
Active ingredient	Daunorubicin hydrochloride
Drug class	Anthracycline cytotoxic
Dosage form	Sterile intravenous injection
Primary indications	Acute myeloid leukemia and acute lymphoblastic leukemia
FDA pathway	New drug application and subsequent generic ANDAs
Originator brand	CERUBIDINE
Originator company	Sanofi, following legacy ownership transfers
Current market type	Mature branded-generic injectable
Main purchasers	Hospitals, health systems, oncology distributors and group purchasing organizations
Biosimilar exposure	None; CERUBIDINE is a small-molecule drug
Principal commercial risk	Generic substitution and sterile injectable supply disruption

The brand has historically been supplied in single-dose vials. Hospital pharmacies generally evaluate daunorubicin products on availability, contract price, vial configuration, supplier reliability and compliance with institutional oncology protocols.

What patents protect CERUBIDINE?

No meaningful unexpired composition-of-matter patent barrier is associated with CERUBIDINE. Daunorubicin is an old anthracycline, and the relevant compound, use and basic formulation rights expired many years ago.

The FDA Orange Book is the principal source for patents and regulatory exclusivities associated with approved small-molecule products. For a mature daunorubicin injection, the commercial question is not whether a pioneer patent blocks generic entry. It is whether an approved supplier can manufacture and distribute a sterile injectable product at sufficient scale.[2]

Are there formulation patents for CERUBIDINE?

Any historical formulation or manufacturing patents would not normally prevent current generic competition. Daunorubicin injection has a relatively conventional parenteral presentation compared with long-acting injectables, liposomal products or complex delivery systems.

Potentially protectable technical subject matter could include:

• Stabilized aqueous or lyophilized formulations
• Vial and reconstitution systems
• Manufacturing processes
• Impurity-control methods
• Packaging and storage conditions
• Combination regimens

These categories do not create a commercially significant CERUBIDINE exclusivity position unless they are linked to an active, enforceable patent and a product-specific Orange Book listing. Public FDA records do not indicate that CERUBIDINE’s commercial position depends on such a barrier.

Does CERUBIDINE have method-of-use patent protection?

The principal therapeutic uses of daunorubicin in leukemia are longstanding clinical uses. They are not protected by a modern, high-value method-of-use estate comparable to newer oncology drugs with biomarker-defined indications.

Clinical protocols may differ by leukemia subtype, patient age, cytogenetic risk, induction regimen and combination partner. Protocol variation affects demand but does not create meaningful patent exclusivity for the legacy brand.

When does CERUBIDINE lose exclusivity?

CERUBIDINE lost practical market exclusivity decades ago. Generic daunorubicin hydrochloride injections are approved through abbreviated new drug applications, allowing reliance on the reference product’s safety and efficacy findings rather than requiring a new full clinical development program.[3]

Exclusivity element	CERUBIDINE status
New chemical entity exclusivity	Expired
Composition-of-matter exclusivity	Expired
Pediatric exclusivity	No material current effect
Orphan-drug exclusivity	Not a current commercial barrier
Orange Book patent barrier	No meaningful current barrier identified
Generic competition	Established
Biosimilar competition	Not applicable

The product’s effective loss of exclusivity occurred before the modern period of high-value oncology patenting. Current market economics therefore reflect generic competition, not patent expiry timing.

What is the Orange Book status of CERUBIDINE?

The Orange Book remains relevant for the reference product and approved generic equivalents, but it does not create a durable brand moat for CERUBIDINE. The key regulatory facts are:

1. Daunorubicin hydrochloride injection is an established small-molecule product.
2. Generic versions may be approved through ANDA pathways.
3. The reference product does not depend on a current patent term to exclude competitors.
4. A Paragraph IV challenge has limited strategic importance once multiple generic suppliers are already active.
5. Hospital substitution can occur through formulary and procurement processes rather than retail pharmacy substitution.

FDA product records and labeling identify the reference product, approved indications, dosing, warnings and administration requirements. They do not imply that the brand retains market exclusivity.[1,3]

Which companies compete with CERUBIDINE?

Competition comes from generic daunorubicin manufacturers and from clinically substitutable leukemia therapies.

Generic daunorubicin suppliers

Generic competition has historically included large injectable manufacturers and specialty sterile-product companies. Supplier participation can change because of manufacturing economics, quality actions, shortages, acquisitions or product discontinuations. The most relevant competitor set is therefore the group of FDA-approved manufacturers with active commercial supply, rather than every company that has ever received an ANDA approval.

The competitive structure is often concentrated. Sterile injectable production requires validated aseptic processing, qualified facilities, controlled raw materials and regulatory compliance. A product can have several approved ANDAs but only a smaller number of dependable commercial suppliers.

Therapeutic alternatives

CERUBIDINE competes clinically with:

• Idarubicin-containing induction regimens
• Doxorubicin in selected hematologic protocols
• Cytarabine-based combination therapy
• Liposomal daunorubicin and cytarabine, including Vyxeos for specified AML populations
• Salvage and targeted therapies selected according to disease biology and treatment line

Vyxeos is not a direct generic equivalent to CERUBIDINE. It is a liposomal fixed combination with a distinct formulation, dosing schedule and regulatory profile. Its higher treatment cost can shift institutional treatment economics even where conventional daunorubicin remains clinically available.[4]

What drives CERUBIDINE demand?

Demand is tied to leukemia treatment volume and protocol selection rather than broad outpatient prescribing. The principal drivers are:

• Incidence of AML and ALL
• Number of induction chemotherapy episodes
• Use of daunorubicin-containing protocols
• Academic-center treatment patterns
• Pediatric and adult oncology formularies
• Availability of alternatives such as idarubicin or Vyxeos
• Hospital inventory and shortage conditions

The product is administered in controlled clinical settings, so demand is relatively inelastic at the patient level but can be highly sensitive to institutional protocol decisions. A hospital can reduce daunorubicin purchases by adopting an alternative regimen without waiting for patent expiry or generic launch.

Daunorubicin demand also depends on cumulative anthracycline exposure. Cardiotoxicity risk can limit use in patients with prior anthracycline therapy, underlying cardiac disease or substantial cumulative dose exposure.[1]

How strong is the CERUBIDINE patent estate?

CERUBIDINE’s patent estate is weak from a present-day commercial perspective.

Patent-estate factor	Assessment
Active compound patent	No current barrier
Long-term formulation exclusivity	No material barrier identified
Method-of-use protection	Limited practical relevance
Delivery-system differentiation	Minimal
Patent litigation leverage	Low
Generic entry deterrence	Low
Manufacturing complexity	Moderate
Regulatory switching friction	Moderate in hospitals

The remaining barriers are operational rather than legal. A new supplier must demonstrate bioequivalence where applicable, meet injectable manufacturing standards, maintain reliable supply and obtain hospital acceptance. Those requirements can delay entry or limit the number of viable suppliers, but they do not provide the originator with exclusivity.

Are there Paragraph IV challenges to CERUBIDINE?

Paragraph IV litigation is not a central current issue for CERUBIDINE. Paragraph IV certifications matter most when an ANDA applicant challenges an unexpired Orange Book patent and seeks to enter before patent expiration. CERUBIDINE’s commercial market matured after the relevant core exclusivities expired, and generic daunorubicin supply is already established.

The more material legal issues for the category are likely to involve:

• FDA manufacturing actions
• Product recalls
• Sterility and contamination investigations
• Supply contracts
• Shortage allocation
• Hospital purchasing disputes
• Patent disputes involving newer formulations or combination products

A Paragraph IV strategy would have limited value unless linked to a specific active patent covering a distinct product presentation.

What patent litigation affects CERUBIDINE?

No major current patent litigation is central to CERUBIDINE’s market position. Litigation involving other anthracycline products, liposomal delivery systems or fixed combinations should not be treated as litigation affecting conventional daunorubicin injection.

The distinction matters commercially. Vyxeos-related intellectual property, for example, may protect a liposomal daunorubicin-cytarabine product without protecting CERUBIDINE or conventional generic daunorubicin. A patent dispute involving a reformulated oncology product does not restore exclusivity to the legacy injection.

What is the financial trajectory for CERUBIDINE?

Standalone CERUBIDINE revenue is not publicly disclosed in Sanofi’s reporting. Sanofi’s financial statements aggregate products into broad business categories and do not identify CERUBIDINE sales as a separate material line item.[5]

The likely financial trajectory is:

Period	Financial profile
Launch and protected period	Higher branded pricing and exclusivity-supported margins
Generic-entry period	Rapid price and share erosion
Mature generic period	Low unit economics, institutional purchasing
Shortage periods	Temporary price or volume volatility
Current outlook	Stable-to-declining brand economics with episodic supply-driven upside

Revenue exposure is likely modest for the originator relative to Sanofi’s major oncology and specialty-care products. The product may still produce recurring sales where hospitals retain the branded item, where procurement contracts favor the originator, or where generic supply is unreliable. That revenue should not be interpreted as evidence of a strong patent position.

For generic manufacturers, the opportunity is a low-growth, low-differentiation market with potential value during supply disruptions. Margins depend on manufacturing utilization, contract terms, raw-material costs, quality compliance and the number of active suppliers.

What generic launch risks exist for CERUBIDINE?

A new generic entrant faces several risks despite the absence of patent barriers:

1. Sterile manufacturing failure can lead to costly recalls and lost hospital contracts.
2. Small market size can make commercial scale difficult.
3. Existing suppliers may respond through aggressive contract pricing.
4. Oncology shortages can create demand but also trigger regulatory scrutiny.
5. Hospitals may qualify only a limited number of vendors.
6. A shortage-driven launch window may close when supply normalizes.
7. Daunorubicin demand can shift when treatment guidelines favor alternative regimens.

The primary barrier is dependable supply, not intellectual property. FDA drug-shortage records should be monitored because injectable oncology products can experience disruptions tied to manufacturing capacity, component shortages and quality events.[6]

How does CERUBIDINE compare with newer AML therapies?

CERUBIDINE is cheaper and more established than newer branded AML therapies, but it has less differentiation and lower pricing power.

Factor	CERUBIDINE	Vyxeos and newer AML products
Product type	Conventional daunorubicin injection	Reformulated or targeted therapy
Patent position	Mature and weak	Potentially active, product-specific
Clinical use	Established leukemia protocols	Defined populations or differentiated regimens
Pricing power	Low	Higher
Generic substitution	Established	Limited or absent for protected products
Manufacturing risk	Sterile injectable supply	Complex formulation or specialty manufacturing
Revenue outlook	Mature, low growth	Dependent on clinical differentiation

CERUBIDINE remains relevant where conventional induction therapy is clinically selected and available. Its commercial ceiling is constrained by generic pricing and protocol substitution.

Key Takeaways

• CERUBIDINE is the branded daunorubicin hydrochloride injection product.
• Its core patents and regulatory exclusivities expired long ago.
• Generic competition, not patent protection, determines current market economics.
• No material current Paragraph IV or patent-litigation threat defines the product.
• The main barriers to competition are sterile injectable manufacturing, regulatory compliance and hospital contracting.
• Sanofi does not publicly disclose standalone CERUBIDINE revenue.
• The brand’s financial trajectory is mature to declining, with temporary volatility during shortages.
• Newer products such as Vyxeos compete through formulation and clinical differentiation rather than direct patent coverage of conventional daunorubicin.
• Biosimilar risk is not applicable because daunorubicin is a small-molecule drug.
• The most relevant diligence items are active commercial suppliers, FDA shortage records, hospital procurement contracts and protocol-level utilization.

FAQs

Is CERUBIDINE still protected by patents?

No meaningful current patent barrier protects conventional CERUBIDINE daunorubicin injection. Generic competition has existed for many years.

Is CERUBIDINE interchangeable with Vyxeos?

No. Vyxeos is a liposomal fixed combination of daunorubicin and cytarabine with distinct dosing, formulation, labeling and clinical use. It is not a generic equivalent to CERUBIDINE.

Can a generic company launch daunorubicin without a patent settlement?

Generally, yes, provided it obtains FDA approval and satisfies applicable ANDA, manufacturing and supply requirements. There is no central current patent settlement controlling conventional daunorubicin entry.

Does CERUBIDINE have biosimilar competition?

No. Biosimilar regulation applies to biological products. CERUBIDINE is a small-molecule anthracycline.

What is the most important investment risk for a CERUBIDINE supplier?

The principal risk is commercial and operational: low market growth, thin margins, hospital price pressure and sterile-injectable supply failures. Patent expiry is not the main risk.

References

1. U.S. Food and Drug Administration. (2010). Cerubidine (daunorubicin hydrochloride) injection prescribing information.
2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application approvals.
4. U.S. Food and Drug Administration. (2017). Vyxeos (daunorubicin and cytarabine) liposome prescribing information.
5. Sanofi. (2024). Universal registration document and annual financial report 2023.
6. U.S. Food and Drug Administration. (n.d.). Drug shortages database.