ANGIOMAX Drug Patent Profile

When do Angiomax patents expire, and when can generic versions of Angiomax launch?

Angiomax is a drug marketed by Sandoz and Maia Pharms Inc and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Angiomax

A generic version of ANGIOMAX was approved as bivalirudin by FRESENIUS KABI USA on October 28^th, 2016.

Summary for ANGIOMAX

US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	19
Patent Applications:	4,423
Drug Prices:	Drug price information for ANGIOMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANGIOMAX
What excipients (inactive ingredients) are in ANGIOMAX?	ANGIOMAX excipients list
DailyMed Link:	ANGIOMAX at DailyMed

See drug prices for ANGIOMAX

Recent Clinical Trials for ANGIOMAX

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

Sponsor	Phase
Legacy Health System	Phase 4
Pacific University	Phase 4
Qian Gong	Phase 2

See all ANGIOMAX clinical trials

Pharmacology for ANGIOMAX

Drug Class	Anti-coagulant Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Paragraph IV (Patent) Challenges for ANGIOMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANGIOMAX	For Injection	bivalirudin	250 mg/vial	020873	1	2009-09-01

US Patents and Regulatory Information for ANGIOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes					Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes					Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes

Expired US Patents for ANGIOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000

EU/EMA Drug Approvals for ANGIOMAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
The Medicines Company UK Ltd	Angiox	bivalirudin	EMEA/H/C/000562 Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel.	Withdrawn	no	no	no	2004-09-20

International Patents for ANGIOMAX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9102750
Germany	122004000042
Australia	6284190
Denmark	0529031

Supplementary Protection Certificates for ANGIOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0489070	SPC/GB04/035	United Kingdom		PRODUCT NAME: H-(D-PHE)-PRO-ARG-PRO-(GLY)4-ASN-GLY-ASP-PHE-GLU-GLU-ILE-PRO-GLU-GLU-TYR-LEU-OH, OPTIONALLY IN THE FORM OF ITS PHARMACEUTICALLY ACCEPTABLE SALT (BIVALIRUDIN); REGISTERED: UK EU/1/04/289/001 20040920
0489070	C00489070/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0489070	91119	Luxembourg		91119, EXPIRES: 20150817
0489070	300162	Netherlands		PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920

ANGIOMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Angiomax (Bivalirudin)

Introduction to Angiomax (Bivalirudin)

Angiomax, known generically as bivalirudin, is a direct thrombin inhibitor used primarily as an anticoagulant in medical procedures such as percutaneous coronary intervention (PCI) and percutaneous transluminal coronary angioplasty (PTCA). Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Growth Projections

The global market for bivalirudin is anticipated to experience significant growth. As of 2023, the market was valued at US$ 596 million and is forecasted to reach US$ 887.2 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.5% during the forecast period of 2024-2030[1].

Key Players in the Market

The bivalirudin market is dominated by several key players, including The Medicines Company, Sandoz, Fresenius Kabi, Pfizer, Mylan, Dr. Reddy's Laboratories, Apotex, Accord Healthcare, and Aurobindo Pharma. These companies play a crucial role in the production, distribution, and marketing of bivalirudin[1][4].

Market Segmentation

The bivalirudin market is segmented based on several criteria:

• Types: The market is segmented into ready-to-use solutions and powder for reconstitution. Each form has its own set of advantages and is used based on clinical requirements[4].
• Applications: Bivalirudin is used in various settings, including drug stores and hospitals. The drug's versatility in different healthcare environments contributes to its market growth[4].
• End Use: The primary end uses are in PCI and PTCA procedures. Bivalirudin's efficacy in these procedures has made it a preferred choice over traditional anticoagulants like heparin[4].

Competitive Landscape

The competitive landscape of the bivalirudin market is dynamic, with several companies vying for market share. Recent developments include:

• Accord Healthcare's license agreement with Foresee Pharma to commercialize bivalirudin in various regions.
• Aurobindo Pharma's acquisition of Apotex’s commercial operations in several European countries.
• Beximo Pharmaceuticals Limited's plan to acquire ANDAs from Sandoz Inc., expanding its product portfolio[4].

Financial Performance of Key Players

The Medicines Company

Historically, The Medicines Company has seen significant revenue from Angiomax sales. For instance, in the third quarter of 2009, U.S. sales of Angiomax increased by 9% to $92.2 million compared to the previous year. International sales also saw a substantial increase of 74% to $5.5 million. Despite strong sales, the company still reported net losses, although these were reduced from $13.2 million to $3.2 million in the same period[5].

In 2017, the company reported a total net revenue of $44.8 million from Angiomax sales, which included both royalty revenues from authorized generic sales by Sandoz and worldwide Angiomax/Angiox net product sales. However, the company incurred significant losses, partly due to impairment charges and other operational costs[2].

Revenue and Cost Dynamics

The revenue from bivalirudin is influenced by several factors, including the drug's high cost and its advantages over other anticoagulants. Despite its benefits, the high cost of bivalirudin restricts its use among patients with low or moderate risk of bleeding. Healthcare institutions are focusing on cost-saving initiatives to reduce the overall drug budget impacted by bivalirudin[4].

Challenges and Opportunities

High Cost and Accessibility

One of the major challenges facing the bivalirudin market is the high cost of the drug. This restricts its use, particularly among patients who cannot afford it. Efforts by healthcare organizations to reduce costs and optimize dosage based on patient conditions are ongoing[4].

Clinical Advantages

Bivalirudin offers several clinical advantages over traditional anticoagulants, such as reduced complications including hemorrhagic and ischemic events. This makes it a preferred choice in certain medical procedures, driving its market growth[4].

Regulatory and Licensing Agreements

The market is also influenced by regulatory and licensing agreements. For example, Accord Healthcare's agreement with Foresee Pharma and Aurobindo Pharma's acquisition of Apotex’s operations are significant moves that impact market dynamics[4].

Future Outlook

The future outlook for the bivalirudin market is positive, driven by increasing demand for anticoagulants with fewer complications. The forecasted growth to US$ 887.2 million by 2030 indicates a strong market trajectory. However, addressing the high cost and ensuring accessibility will be crucial for sustained growth[1].

Key Takeaways

• Market Growth: The global bivalirudin market is expected to grow from US$ 596 million in 2023 to US$ 887.2 million by 2030.
• Key Players: The Medicines Company, Sandoz, Fresenius Kabi, Pfizer, Mylan, Dr. Reddy's Laboratories, Apotex, Accord Healthcare, and Aurobindo Pharma are major players.
• Market Segmentation: Segmented by types, applications, and end use, with a focus on PCI and PTCA procedures.
• Financial Performance: Strong sales but significant operational costs and losses for some key players.
• Challenges and Opportunities: High cost and clinical advantages are key factors influencing market dynamics.

FAQs

Q: What is the forecasted market size for bivalirudin by 2030?

A: The global market for bivalirudin is forecasted to reach US$ 887.2 million by 2030[1].

Q: Who are the main players in the bivalirudin market?

A: The main players include The Medicines Company, Sandoz, Fresenius Kabi, Pfizer, Mylan, Dr. Reddy's Laboratories, Apotex, Accord Healthcare, and Aurobindo Pharma[1][4].

Q: What are the primary end uses of bivalirudin?

A: The primary end uses are in PCI and PTCA procedures[4].

Q: Why is the high cost of bivalirudin a significant issue?

A: The high cost restricts its use among patients with low or moderate risk of bleeding and impacts the overall drug budget of healthcare institutions[4].

Q: How does bivalirudin compare to other anticoagulants?

A: Bivalirudin offers reduced complications including hemorrhagic and ischemic events compared to traditional anticoagulants like heparin[4].

Sources

1. Valuates Reports: Bivalirudin Drug - Market Size.
2. Business Wire: The Medicines Company Reports Fourth-Quarter and Full-Year 2017 Business and Financial Results.
3. Access to Medicine Foundation: Antimicrobial Resistance Benchmark 2018.
4. Biospace: Bivalirudin Drug Market New Development and Competitive Analysis Report.
5. Cardiovascular Business: Strong Angiomax sales continue to lower losses for Medicines in Q3.