Apixaban - Generic Drug Details

What are the generic sources for apixaban and what is the scope of patent protection?

Apixaban is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Indoco, Micro Labs, Mylan, Zydus Pharms, and Bristol Myers Squibb, and is included in eleven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apixaban has one hundred and seventy-one patent family members in forty-two countries.

There are thirty drug master file entries for apixaban. Ten suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for apixaban

International Patents:	171
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	211
Patent Applications:	4,911
Drug Sales Revenues:	Drug sales revenues for apixaban
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apixaban
What excipients (inactive ingredients) are in apixaban?	apixaban excipients list
DailyMed Link:	apixaban at DailyMed

See drug sales revenues for apixaban

Recent Clinical Trials for apixaban

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

Sponsor	Phase
Centre Hospitalier Universitaire Vaudois	Phase 2
Imperial College London	Phase 4
Janssen Research & Development, LLC	Phase 3

See all apixaban clinical trials

Generic filers with tentative approvals for APIXABAN

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL
		2.5MG	TABLET; ORAL
		5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for apixaban

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for apixaban

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for APIXABAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELIQUIS	Tablets	apixaban	2.5 mg and 5 mg	202155	25	2016-12-28

US Patents and Regulatory Information for apixaban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-001	Dec 23, 2019		DISCN	No	No
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-002	Sep 11, 2020	AB	RX	No	No
Apotex	APIXABAN	apixaban	TABLET;ORAL	210091-002	Feb 16, 2024		DISCN	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No	6,967,208		Y	Y

Expired US Patents for apixaban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	6,413,980
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	6,413,980

EU/EMA Drug Approvals for apixaban

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb / Pfizer EEIG	Eliquis	apixaban	EMEA/H/C/002148 For Eliquis 2.5 mg film-coated tablets:Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).For Eliquis 5 mg film-coated tablets:Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).	Authorised	no	no	no	2011-05-18
Accord Healthcare S.L.U.	Apixaban Accord	apixaban	EMEA/H/C/005358 Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).	Authorised	yes	no	no	2020-07-23

International Patents for apixaban

Country	Patent Number	Title	Estimated Expiration
Spain	2767848
Portugal	2538925
Chile	2008002717
Hungary	E047139

Supplementary Protection Certificates for apixaban

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
1427415	122011100050	Germany		PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	91888	Luxembourg		91888, EXPIRES: 20260518
1427415	443	Finland

Apixaban Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Apixaban

Introduction to Apixaban

Apixaban, marketed under the brand name Eliquis, is a novel oral anticoagulant (NOAC) used to prevent and treat various cardiovascular conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke in patients with atrial fibrillation. Here, we delve into the market dynamics and financial trajectory of apixaban.

Market Size and Growth

The apixaban market has been experiencing robust growth. In 2023, the market size was valued at $2.69 billion and is projected to increase to $2.92 billion in 2024, with a compound annual growth rate (CAGR) of 8.7%[1].

By 2028, the market is expected to expand to $4.12 billion, driven by a CAGR of 9.0%. This growth is attributed to the increasing incidence of cardiovascular diseases, aging populations, and advancements in drug delivery systems[1].

Drivers of Market Growth

Rising Prevalence of Cardiovascular Diseases

The growing prevalence of cardiovascular diseases, including coronary artery disease, stroke, and heart failure, is a significant driver. Factors such as sedentary lifestyles, poor dietary habits, tobacco use, obesity, high blood pressure, and diabetes contribute to this trend. For instance, according to the American Heart Association, cardiovascular diseases resulted in 931,578 deaths in the U.S. in 2023, highlighting the need for effective anticoagulants like apixaban[1].

Aging Population

The global aging population is another key driver. As the population ages, the incidence of conditions requiring anticoagulation therapy increases, thereby boosting the demand for apixaban[1].

Regulatory Approvals and Expansions

Regulatory approvals and expansions have played a crucial role in the market's growth. Apixaban's approval by the FDA for various indications, including the prevention and treatment of DVT and PE, has expanded its therapeutic reach[3].

Shift from Warfarin to NOACs

The shift from traditional anticoagulants like warfarin to NOACs is also driving growth. NOACs, including apixaban, offer more favorable clinical outcomes and easier management compared to warfarin, making them a preferred choice for many patients and healthcare providers[1].

Market Segmentation

By Dosage Form

The apixaban market is segmented by dosage form into capsules and tablets. Both forms are widely used, with tablets being a more common dosage form due to their ease of administration and patient compliance[1][4].

By Application

Apixaban is used for several applications, including the prevention and treatment of DVT and PE, and the reduction of the risk of recurrent PE and DVT following initial treatment. These applications are critical in managing venous thromboembolism-related illnesses[1][3].

By End-Users

The market is segmented by end-users into hospitals, homecare, specialty clinics, and other end-users. Hospitals and homecare settings are significant segments due to the widespread use of apixaban in these environments[1][4].

Regional Analysis

North America

North America was the largest region in the apixaban market in 2023, driven by high healthcare investments and awareness. The U.S. is a key market within this region, with significant revenue contributions[1][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market during the forecast period. This growth is driven by developing healthcare facilities, a large number of generic manufacturers, and increasing government initiatives[1][4].

Financial Impact of Regulatory Changes

The Inflation Reduction Act (IRA) of 2022 has introduced significant changes that impact the pricing and revenue of apixaban. The maximum fair price (MFP) for a 30-day supply of Eliquis, set at $231, will affect Medicare reimbursement rates starting January 1, 2026. This change is expected to influence U.S. and worldwide revenues, with projected revenue ranges for 2026 and 2027 between $8.5 billion to $12.5 billion[2][5].

Competitive Landscape and Acquisitions

The apixaban market is marked by significant competitive activities. For example, the acquisition of Apotex Pharmaceutical Holdings Inc. by SK Capital Partners in 2022 could transform the pharmaceutical sector, influencing drug manufacturing, distribution channels, and research endeavors[1].

Challenges and Risks

Despite the growth, the market faces several challenges. Side effects such as an increased risk of thrombotic events upon premature withdrawal and bleeding can stymie apixaban's adoption. Additionally, the impact of generic entry, regulatory changes, and competitive products in the Medicare market pose risks to future revenue[3][5].

Innovations and Collaborations

Advancements in drug delivery systems, increasing research and development, and innovation through collaborations are expected to drive the market forward. Digital health and telemedicine are also emerging trends that could enhance the accessibility and effectiveness of apixaban treatment[1].

Key Takeaways

• The apixaban market is projected to grow significantly, driven by the rising prevalence of cardiovascular diseases and an aging population.
• Regulatory approvals and the shift from warfarin to NOACs are key drivers.
• The market is segmented by dosage form, application, and end-users, with North America and Asia-Pacific being significant regions.
• Regulatory changes under the IRA will impact pricing and revenue.
• Innovations and collaborations are expected to continue driving market growth.

FAQs

1. What are the primary drivers of the apixaban market growth?

The primary drivers include the rising prevalence of cardiovascular diseases, an aging population, regulatory approvals, and the shift from warfarin to NOACs.

2. How does the Inflation Reduction Act (IRA) impact the apixaban market?

The IRA sets a maximum fair price for a 30-day supply of Eliquis, affecting Medicare reimbursement rates and influencing U.S. and worldwide revenues.

3. Which regions are expected to be the largest and fastest-growing in the apixaban market?

North America is currently the largest region, while the Asia-Pacific region is expected to be the fastest-growing during the forecast period.

4. What are the common dosage forms of apixaban?

Apixaban is available in both capsule and tablet forms, with tablets being more commonly used.

5. What are the potential challenges facing the apixaban market?

Challenges include side effects such as bleeding and thrombotic events, generic entry, and regulatory changes that could impact revenue.

Cited Sources:

1. The Business Research Company. Global Apixaban Market Report 2024.
2. Bristol-Myers Squibb Company. Investor Statement on Eliquis Revenue Under IRA.
3. PharmiWeb. Global Apixaban {Eliquis} Market is expected to grow significantly with a CAGR of 7.5% during the forecast period.
4. Data Bridge Market Research. Global Apixaban Market – Industry Trends and Forecast to 2030.
5. Pfizer. Pfizer Statement on Publication of ELIQUIS® Maximum Fair Price.