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ELIQUIS Drug Profile
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Which patents cover Eliquis, and what generic alternatives are available?
Eliquis is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-five patent family members in forty-three countries.
The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the apixaban profile page.
US ANDA Litigation and Generic Entry Outlook for Eliquis
Eliquis was eligible for patent challenges on December 28th, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 21st, 2026. This may change due to patent challenges or generic licensing.
Annual sales in 2017 were $4.4bn, indicating a strong incentive for generic entry.
There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are three tentative approvals for the generic drug (apixaban), which indicates the potential for near-term generic launch.
Summary for ELIQUIS
| International Patents: | 165 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 56 |
| Patent Applications: | 1,073 |
| 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 |
Generic Entry Opportunity Date for ELIQUIS
Generic Entry Date for ELIQUIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ELIQUIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yale University | Phase 3 |
| University of Zurich | Phase 3 |
| Mansoura University | Phase 1/Phase 2 |
Recent Litigation for ELIQUIS
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bristol-Myers Squibb Company v. Dr. Reddy's Laboratories, Ltd. | 2018-01-19 |
| Bristol-Myers Squibb Company v. Prinston Pharmaceutical Inc. | 2017-04-13 |
| Bristol-Myers Squibb Company v. Mylan Pharmaceuticals Inc. | 2017-04-12 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2018-04-05 |
| Coalition for Affordable Drugs IX, LLC | 2015-08-13 |
Pharmacology for ELIQUIS
| Drug Class | Factor Xa Inhibitor |
| Mechanism of Action | Factor Xa Inhibitors |
Synonyms for ELIQUIS
| 1-(4-Methoxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid amide |
| 1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo(3,4c)pyridine-3-carboxamide |
| 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide |
| 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo piperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide |
| 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidyl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide |
| 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridine-3-carboxamide |
| 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-car |
| 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide |
| 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide |
| 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide?BMS-562247; BMS-562247-01 |
| 1H-Pyrazolo(3,4-c)pyridine-3-carboxamide,4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)- |
| 1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]- |
| 2p16 |
| 3Z9Y7UWC1J |
| 503612-47-3 |
| 612A473 |
| AB0007933 |
| AB01565766_02 |
| AB1008435 |
| ABP000333 |
| AC-26301 |
| AJ-59962 |
| AKOS005146204 |
| AN-429 |
| AOB87769 |
| Apixaban |
| Apixaban - Adooq Bioscience |
| Apixaban (BMS 562247-01) |
| Apixaban (JAN/USAN/INN) |
| Apixaban [USAN:INN:JAN] |
| Apixaban BMS-562247-01 |
| Apixaban,BMS-562247-01 |
| Apixaban;503612-47-3 |
| Apixaban(BMS-562247-01) |
| Apixaban/BMS562247-01/Apixaban |
| apixabanum |
| Apixabin |
| AX8161411 |
| BC654125 |
| BCP02451 |
| BCP9000310 |
| BCPP000396 |
| BDBM19023 |
| BMS 562247-01 |
| BMS-562247 |
| BMS-562247-01 |
| BMS562247-01 |
| CA0186 |
| CCG-229675 |
| CHEBI:72296 |
| CHEMBL231779 |
| CS-0401 |
| D03213 |
| DB06605 |
| DTXSID80436500 |
| Eliquis (TN) |
| EX-A048 |
| FT-0686944 |
| GG2 |
| GTPL6390 |
| HMS3655O07 |
| HSDB 8223 |
| HY-50667 |
| I14-11577 |
| J-200194 |
| KB-47429 |
| KS-0000075V |
| ME-0152 |
| MLS006010026 |
| MolPort-006-170-153 |
| NCGC00346555-01 |
| NCGC00346555-08 |
| PB10976 |
| PYR431 |
| Q-4456 |
| QC-8191 |
| QNZCBYKSOIHPEH-UHFFFAOYSA-N |
| RP18047 |
| s1593 |
| SC-49755 |
| SCHEMBL118023 |
| SMR004676529 |
| ST24045978 |
| SW220177-1 |
| UNII-3Z9Y7UWC1J |
| X1060 |
| ZINC11677837 |
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 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | 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 |
|---|---|---|
| Mexico | PA04002526 | Start Trial |
| Russian Federation | 2008134413 | Start Trial |
| Portugal | 2538925 | Start Trial |
| Poland | 373299 | Start Trial |
| China | 102770126 | Start Trial |
| Argentina | 037092 | Start Trial |
| Japan | 6192078 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ELIQUIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1427415 | PA2011012,C1427415 | Lithuania | Start Trial | PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518 |
| 1427415 | 11C0042 | France | Start Trial | PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110518 |
| 1427415 | CA 2011 00028 | Denmark | Start Trial | |
| 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 | 122011100050 | Germany | Start Trial | PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518 |
| 1427415 | 2011/032 | Ireland | Start Trial | PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518 |
| 1427415 | 2011C/034 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
