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Last Updated: May 18, 2024

ELIQUIS Drug Patent Profile


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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 patent family members in forty-two countries.

The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Eight 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 28th, 2020.

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Drug patent expirations by year for ELIQUIS
Drug Prices for ELIQUIS

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Drug Sales Revenue Trends for ELIQUIS

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Recent Clinical Trials for ELIQUIS

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

SponsorPhase
Centre Hospitalier Universitaire VaudoisPhase 2
Regeneron PharmaceuticalsPhase 2
Laval UniversityPhase 2

See all ELIQUIS clinical trials

Pharmacology for ELIQUIS
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor 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.

Patents protecting ELIQUIS

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PULMONARY EMBOLISM (PE)

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT)

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCE THE RISK OF RECURRENT PULMONARY EMBOLISM

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DEEP VEIN THROMBOSIS (DVT)

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REDUCING THE RISK OF STROKE

Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF PULMONARY EMBOLISM

Apixaban formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ELIQUIS

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

Country Patent Number Title Estimated Expiration
China 110894196 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011106478 ⤷  Try a Trial
Malaysia 137830 LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS ⤷  Try a Trial
South Africa 201205807 APIXABAN FORMULATIONS ⤷  Try a Trial
Russian Federation 2004112191 ⤷  Try a Trial
Iceland 8803 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ELIQUIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1427415 C 2011 008 Romania ⤷  Try a Trial PRODUCT NAME: APIXABANSI SARURI ACCEPTABILE FARMACEUTIC ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/691/001, RO EU/1/11/691/002, RO EU/1/11/691/003, RO EU/1/11/691/004, RO EU/1/11/691/005; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/691/001, EU/1/11/691/002, EU/1/11/691/003, EU/1/11/691/004, EU/1/11/691/005; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1427415 122011100050 Germany ⤷  Try a Trial PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 CA 2011 00028 Denmark ⤷  Try a Trial
1427415 1190029-7 Sweden ⤷  Try a Trial PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415 C20110017 00045 Estonia ⤷  Try a Trial PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
1427415 115 5011-2011 Slovakia ⤷  Try a Trial OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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