ELIQUIS Drug Patent Profile

Which patents cover Eliquis, and when can generic versions of Eliquis launch?

Eliquis is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the apixaban profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eliquis

A generic version of ELIQUIS was approved as apixaban by ACCORD HLTHCARE on July 28^th, 2020.

Summary for ELIQUIS

International Patents:	171
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	72
Patent Applications:	3,007
Drug Prices:	Drug price information for ELIQUIS
Drug Sales Revenues:	Drug sales revenues for ELIQUIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIQUIS
What excipients (inactive ingredients) are in ELIQUIS?	ELIQUIS excipients list
DailyMed Link:	ELIQUIS at DailyMed

See drug prices for ELIQUIS

See drug sales revenues for ELIQUIS

Recent Clinical Trials for ELIQUIS

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

Sponsor	Phase
Centre Hospitalier Universitaire Vaudois	Phase 2
Regeneron Pharmaceuticals	Phase 2
Laval University	Phase 2

See all ELIQUIS clinical trials

Pharmacology for ELIQUIS

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Paragraph IV (Patent) Challenges for ELIQUIS

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 ELIQUIS

ELIQUIS is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No	6,967,208		Y	Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No	9,326,945		Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	AB	RX	Yes	Yes	9,326,945		Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	AB	RX	Yes	Yes	6,967,208		Y	Y

Expired US Patents for ELIQUIS

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 ELIQUIS

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 ELIQUIS

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

Country	Patent Number	Title	Estimated Expiration
Serbia	59576	FORMULACIJE APIKSABANA (APIXABAN FORMULATIONS)
Canada	2791171	FORMULATIONS D'APIXABAN (APIXABAN FORMULATIONS)
Hungary	E047139
European Patent Office	1140941	HETEROBICYCLIQUES CONTENANT DE L'AZOTE UTILISES COMME INHIBITEURS DU FACTEUR XA (NITROGEN CONTAINING HETEROBICYCLES AS FACTOR XA INHIBITORS)

Supplementary Protection Certificates for ELIQUIS

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

ELIQUIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eliquis

Introduction

Eliquis, known generically as apixaban, is a potent anticoagulant developed by Bristol-Myers Squibb and Pfizer. It has become a crucial player in the pharmaceutical market, particularly in the treatment and prevention of conditions such as atrial fibrillation, deep vein thrombosis, and pulmonary embolism. Here, we delve into the market dynamics and financial trajectory of Eliquis.

Market Size and Forecast

The Eliquis market has shown significant growth and is projected to continue this trend. As of 2023, the market size was valued at USD 31.04 billion and is expected to reach USD 75.53 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9.3% during the forecast period from 2024 to 2031[1].

Key Growth Drivers

Increasing Awareness and Diagnoses

Growing awareness of atrial fibrillation and other thromboembolic conditions is leading to more diagnoses, thereby increasing the patient population that might be prescribed Eliquis. This increased diagnosis rate is a significant driver of market growth[1].

Healthcare Expenditure and Access to Medications

Rising healthcare expenditures and the increasing availability of medications in various markets facilitate greater access to Eliquis. This trend is particularly evident in regions with robust healthcare systems and growing healthcare infrastructure[1].

Market Exclusivity and Patent Protection

The patent protection of Eliquis limits generic competition, allowing for sustained revenue generation for the manufacturers. However, this protection is set to expire, which could lead to the introduction of generic alternatives and impact Eliquis’s market share and pricing[1][4].

Partnerships and Marketing Strategies

Effective marketing strategies and partnerships between pharmaceutical companies and healthcare providers enhance the visibility and market penetration of Eliquis. These collaborations are crucial for expanding the drug's reach and ensuring its continued adoption[1].

Expansion to New Markets

The introduction of Eliquis in emerging markets with growing healthcare infrastructure is another key growth driver. Regions such as the Asia-Pacific, characterized by an increasing burden of lifestyle-related diseases and rising healthcare spending, present significant opportunities for market expansion[1].

Regulatory and Market Challenges

Regulatory Approvals and Scrutiny

The approval of drugs in the anticoagulant class often involves rigorous regulatory scrutiny. Any delays or challenges in obtaining approval for new formulations or indications can restrain market growth. The impact of the Inflation Reduction Act (IRA) in the U.S., for example, has introduced new pricing dynamics that could affect Eliquis’s revenue in the Medicare market[1][4].

Generic Competition

The expiration of patent protection for Eliquis may lead to the availability of generic alternatives, which could significantly impact Eliquis’s market share and pricing. This competition is expected to be a major challenge in the coming years[1][4].

Adverse Effects and Safety Concerns

The risk of side effects, such as bleeding complications, may lead to patient reluctance and could hinder the drug’s adoption among healthcare providers. These safety concerns are a continuous challenge for the market growth of Eliquis[1][3].

High Cost

Eliquis is relatively expensive compared to some traditional anticoagulants. This high cost may limit its accessibility, particularly in regions with less healthcare funding or among uninsured patients. The introduction of the maximum fair price (MFP) under the IRA in the U.S. Medicare channel may also impact pricing strategies[1][4].

Market Segmentation

End-User Segmentation

The Eliquis market is segmented by end-users, including hospitals, outpatient clinics, and pharmacies. Hospitals are significant end-users, administering Eliquis for managing acute conditions, while outpatient clinics provide a continuum of care for patients managing chronic conditions[1].

Geographic Segmentation

Geographically, the market dynamics vary significantly. Europe, with its robust healthcare systems, exhibits high adoption rates, while the Asia-Pacific region presents a rapidly growing opportunity due to increasing healthcare spending and improving access to advanced medications. The Middle East and Africa face challenges such as limited healthcare resources but hold considerable potential as healthcare investments rise[1].

Financial Performance

Revenue Growth

Eliquis has shown steady revenue growth. For instance, Bristol-Myers Squibb reported that worldwide revenues for Eliquis increased by 7% in 2023, with U.S. revenues rising by 11% due to higher demand[5].

Impact of IRA on Pricing

The Inflation Reduction Act (IRA) has introduced a maximum fair price (MFP) for Eliquis in the U.S. Medicare channel, which is expected to impact revenues in 2026 and 2027. Bristol-Myers Squibb anticipates U.S. and worldwide Eliquis revenues to be affected by these pricing changes[4].

Operational and Financial Projections

Pfizer, another key player in the Eliquis market, reported a decline in overall revenues in 2023 due to the impact of COVID-19-related products like Comirnaty and Paxlovid. However, excluding these contributions, revenues grew operationally. The company is on track to deliver significant cost savings through its cost realignment program, which could positively impact the financial trajectory of Eliquis[2].

Competitive Landscape

Emerging Novel Therapeutics

New and emerging anticoagulant therapies that offer better safety profiles, dosing convenience, or efficacy may pose a competitive threat to Eliquis. The market is becoming increasingly crowded, with multiple competing products available, which can dilute Eliquis’s market share and lead to price competition[1].

Patient Adherence and Healthcare Provider Preferences

The need for ongoing therapy and the potential for side effects may affect patient adherence to Eliquis, impacting overall market demand. Additionally, some healthcare professionals may prefer alternative therapies or generic options, further influencing prescribing behavior[1].

Formulary Restrictions

Health insurance formulary restrictions or the preference for cheaper alternatives may limit Eliquis’s prescription rates among insured patients. These restrictions can significantly impact the drug’s market penetration and revenue[1].

Key Takeaways

• Growing Market Size: The Eliquis market is projected to grow significantly, reaching USD 75.53 billion by 2031.
• Key Growth Drivers: Increasing awareness of thromboembolic conditions, rising healthcare expenditures, market exclusivity, and expansion into new markets.
• Regulatory and Market Challenges: Generic competition, adverse effects, high cost, and regulatory scrutiny.
• Financial Performance: Steady revenue growth, impacted by IRA pricing changes and operational cost savings.
• Competitive Landscape: Emerging novel therapeutics, patient adherence issues, and healthcare provider preferences.

FAQs

What is the projected market size of Eliquis by 2031?

The Eliquis market is projected to reach USD 75.53 billion by 2031, growing at a CAGR of 9.3% during the forecast period from 2024 to 2031[1].

What are the main growth drivers for the Eliquis market?

The main growth drivers include increasing awareness of atrial fibrillation and other thromboembolic conditions, rising healthcare expenditures, market exclusivity, and expansion into new markets[1].

How does the Inflation Reduction Act (IRA) impact Eliquis revenues?

The IRA introduces a maximum fair price (MFP) for Eliquis in the U.S. Medicare channel, which is expected to impact revenues in 2026 and 2027. This pricing change could affect the financial trajectory of Eliquis[4].

What are the significant challenges facing the Eliquis market?

Significant challenges include generic competition, adverse effects, high cost, regulatory scrutiny, and the impact of emerging novel therapeutics[1].

How does the competitive landscape affect Eliquis?

The competitive landscape, including emerging novel therapeutics, patient adherence issues, and healthcare provider preferences, can dilute Eliquis’s market share and lead to price competition[1].

What is the current financial performance of Eliquis?

Eliquis has shown steady revenue growth, with worldwide revenues increasing by 7% in 2023. However, the impact of IRA pricing changes and operational cost savings will be crucial in the coming years[5].

Sources

1. Verified Market Research: Eliquis Market Size, Share, Scope, Trends, Growth & Forecast.
2. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance.
3. PharmiWeb: Global Apixaban {Eliquis} Market is expected to grow significantly with a CAGR of 7.5% during the forecast period.
4. Bristol-Myers Squibb: Investor Statement on Eliquis Revenue Under IRA.
5. Bristol-Myers Squibb: Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023.