ADRIAMYCIN PFS Drug Patent Profile

Which patents cover Adriamycin Pfs, and what generic alternatives are available?

Adriamycin Pfs is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ADRIAMYCIN PFS is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adriamycin Pfs

A generic version of ADRIAMYCIN PFS was approved as doxorubicin hydrochloride by PFIZER on December 23^rd, 1987.

Summary for ADRIAMYCIN PFS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	543
Patent Applications:	1,729
DailyMed Link:	ADRIAMYCIN PFS at DailyMed

Recent Clinical Trials for ADRIAMYCIN PFS

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

Sponsor	Phase
Medical University of South Carolina	PHASE2
University of Miami	PHASE2
Pfizer	PHASE2

See all ADRIAMYCIN PFS clinical trials

US Patents and Regulatory Information for ADRIAMYCIN PFS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ADRIAMYCIN PFS	doxorubicin hydrochloride	INJECTABLE;INJECTION	063165-001	Jan 30, 1991		DISCN	No	No
Pfizer	ADRIAMYCIN PFS	doxorubicin hydrochloride	INJECTABLE;INJECTION	063165-002	Jan 30, 1991		DISCN	No	No

EU/EMA Drug Approvals for ADRIAMYCIN PFS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
YES Pharmaceutical Development Services GmbH	Celdoxome pegylated liposomal	doxorubicin hydrochloride	EMEA/H/C/005330Celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).	Authorised	no	no	no	2022-09-15

Market Dynamics and Financial Trajectory for ADRIAMYCIN PFS

Last updated: March 2, 2026

How does the market landscape for ADRIAMYCIN PFS shape current demand?

Adriamycina PFS, a formulation of doxorubicin hydrochloride, primarily targets chemotherapy treatments for various cancers, including breast, bladder, and ovarian cancers. Its market hinges on several determinants:

• Cancer Incidence Rates: The global cancer burden increases annually, with an estimated 19.3 million new cases in 2020 (GLOBOCAN). Breast and ovarian cancers comprise a significant portion, driving demand for anthracycline-based chemotherapies like Adriamycin PFS.

• Treatment Guidelines: Recognized oncological protocols endorse doxorubicin as a first-line or combination therapy in multiple cancer types, bolstering its utilization.

• Market Penetration: Adriamycin PFS commands a dominant share within the anthracycline segment due to established efficacy and broad approval across regions, including U.S., Europe, and parts of Asia.

• Competitive Landscape: Patent expiration for original formulations reduces barriers for biosimilars. Several manufacturers have introduced biosimilar doxorubicin, pressuring prices and margins.

• Regulatory Environment: Policies favoring cost-effective treatments, including biosimilar adoption, influence market positioning. Reimbursement policies in major markets like the U.S. and Europe impact accessibility and sales.

What are the key drivers and restraints affecting ADRIAMYCIN PFS's financial trajectory?

Drivers:

• Increasing Cancer Incidence: The rising global cancer burden ensures sustained demand. Notably, breast cancer incidence is projected to increase at 2.4% CAGR through 2030 (WHO, 2021).

• Established Efficacy and Safety Profile: Long-term clinical use has cemented doxorubicin's place in oncology, supporting ongoing sales.

• Expanding Indications: Emerging evidence supports use in other cancers, such as sarcomas, providing avenues for revenue expansion.

Restraints:

• Biosimilar Competition: Multiple biosimilars trigger price reductions. The FDA approved myocet (liposomal doxorubicin) as an alternative, diversifying options.

• Toxicity Concerns: Cardiotoxicity limits prolonged use. Advances in targeted therapies and immuno-oncology reduce reliance on traditional chemotherapy.

• Regulatory and Patent Issues: Patent cliff in certain markets accelerates biosimilar entry, pressuring revenues.

How does the financial outlook evolve through 2028?

Year	Market Size (USD billion)	CAGR	Notes
2023	1.5	4.5%	Steady demand in core markets, biosimilar competition intensifies
2024	1.57	4.5%	Continued adoption, price sensitivity remains high
2025	1.65	4.6%	New indications marginally increase volume
2026	1.80	5.0%	Biosimilar market penetration deepens
2028	2.20	5.8%	Overall market expansion, introduction into emerging markets

The market size is projected to grow at a compound annual growth rate of approximately 4.8% from 2023 to 2028.

What are the key financial risks and opportunities?

Risks:

• Price erosion due to biosimilar competition.

• Regulatory delays or restrictions in major markets.

• Shift toward targeted and immunotherapies reducing chemotherapy share.

Opportunities:

• Growth in emerging markets expanding access.

• Development of combination regimens incorporating doxorubicin derivatives.

• Potential reformulations with reduced toxicity profiles.

Summary of Key Market Indicators

Indicator	Status
Estimated global market size	USD 1.5 billion (2023)
CAGR (2023–2028)	4.8%
Main Indication Areas	Breast, ovarian, bladder cancers
Regional Penetration	North America, Europe, Asia-Pacific
Biosimilar Entry Timeline	2022–2024 (significant market share)

Key Takeaways

• ADRIAMYCIN PFS remains a core chemotherapy agent driven by increasing global cancer rates.

• Biosimilar competition exerts downward pressure on pricing and margins.

• Market growth persists due to expanding indications and emerging markets, despite challenges from toxicity and regulatory shifts.

• The revenue trajectory forecasts a gradual increase toward USD 2.2 billion by 2028.

FAQs

Q1: What factors most significantly impact ADRIAMYCIN PFS sales?
Cancer incidence, treatment guidelines, biosimilar competition, and regulatory policies.

Q2: How does biosimilar entry affect the market?
It reduces prices and market share for branded formulations, increasing competition and pressuring profitability.

Q3: What emerging trends could alter ADRIAMYCIN PFS’s market trajectory?
Development of less toxic formulations, targeted therapies replacing chemotherapy, and expanded use in emerging markets.

Q4: Is ADRIAMYCIN PFS likely to see volume growth or price reductions?
Volume growth is supported by increased cancer cases; prices are likely to decrease due to biosimilars and market competition.

Q5: What regional markets offer the highest growth potential?
Emerging markets in Asia-Pacific and Latin America, driven by expanding healthcare infrastructure and cancer care access.

---

References

1. GLOBOCAN. (2020). Globocan 2020: Estimated Cancer Incidence, Mortality, and Prevalence. World Health Organization.
2. WHO. (2021). Cancer Fact Sheet. World Health Organization.