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ELIQUIS Drug 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 sixty-six patent family members in forty-two countries.
The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the apixaban profile page.
US ANDA Litigation and Generic Entry Outlook for Eliquis
A generic version of ELIQUIS was approved as apixaban by ACCORD HLTHCARE on July 28th, 2020.
Summary for ELIQUIS
| International Patents: | 166 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 108 |
| Clinical Trials: | 61 |
| Patent Applications: | 2,400 |
| Formulation / Manufacturing: | see details |
| 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 |
| DailyMed Link: | ELIQUIS at DailyMed |
Recent Clinical Trials for ELIQUIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network | Phase 4 |
| Thomas Ortel, M.D., Ph.D. | Phase 3 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
Pharmacology for ELIQUIS
| Drug Class | Factor Xa Inhibitor |
| Mechanism of Action | Factor Xa Inhibitors |
US Patents and Regulatory Information for ELIQUIS
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | |
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | Start Trial | Start Trial |
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ELIQUIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Montenegro | 00090 | Start Trial |
| Japan | 2005507889 | Start Trial |
| Slovenia | 3017811 | Start Trial |
| Portugal | 2538925 | Start Trial |
| Serbia | 59593 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ELIQUIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1427415 | 91888 | Luxembourg | Start Trial | 91888, EXPIRES: 20260518 |
| 1427415 | SPC/GB11/042 | United Kingdom | Start Trial | PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/11/691/001 20110520; UK EU/1/11/691/002 20110520; UK EU/1/11/691/003 20110520; UK EU/1/11/691/004 20110520; UK EU/1/11/691/005 20110520 |
| 1427415 | C01427415/01 | Switzerland | Start Trial | FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US |
| 1427415 | 31/2011 | Austria | Start Trial | PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520 |
| 1427415 | C 2011 008 | Romania | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
