Eliquis is a drug owned by Bristol Myers Squibb Co Pharmaceutical Research Institute. It is protected by 3 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 1 has expired. Eliquis's patents have been open to challenges since 28 December, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 24, 2031. Details of Eliquis's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6967208 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors |
Nov, 2026
(1 year, 10 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9326945 | Apixaban formulations |
Feb, 2031
(6 years from now) | Active |
| US6413980 | Nitrogen containing heterobicycles as factor Xa inhibitors |
Dec, 2019
(5 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Eliquis's patents.
Latest Legal Activities on Eliquis's Patents
Given below is the list of recent legal activities going on the following patents of Eliquis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Oct, 2023 | US9326945 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Oct, 2019 | US9326945 (Litigated) |
| Termination or Final Written Decision | 16 Jan, 2019 | US9326945 (Litigated) |
| Request for Trial Granted Critical | 15 Oct, 2018 | US9326945 (Litigated) |
| Mail Certificate of Correction Memo | 06 Sep, 2018 | US6967208 |
| Post Issue Communication - Certificate of Correction | 06 Sep, 2018 | US6967208 |
| Certificate of Correction Memo | 29 Aug, 2018 | US6967208 |
| Mail Certificate of Correction Memo | 13 Aug, 2018 | US6967208 |
| Post Issue Communication - Certificate of Correction | 11 Aug, 2018 | US6967208 |
| Certificate of Correction Memo | 10 Aug, 2018 | US6967208 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Eliquis and ongoing litigations to help you estimate the early arrival of Eliquis generic.
Eliquis's Litigations
Eliquis been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 13, 2015, against patent number US6967208. The petitioner Coalition for Affordable Drugs IX, LLC, challenged the validity of this patent, with Bristol-Myers Squibb Company as the respondent. Click below to track the latest information on how companies are challenging Eliquis's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9326945 | April, 2018 |
Terminated-Settled
(16 Jan, 2019) | Pfizer Inc. | Mylan Pharmaceuticals Inc. |
| US6967208 | August, 2015 |
Terminated-Denied
(22 Feb, 2016) | Bristol-Myers Squibb Company | Coalition for Affordable Drugs IX, LLC |
FDA has granted some exclusivities to Eliquis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Eliquis, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Eliquis.
Exclusivity Information
Eliquis holds 5 exclusivities. All of its exclusivities have expired in 2017. Details of Eliquis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-681) | Mar 03, 2017 |
| New Indication(I-661) | Aug 21, 2017 |
| New Indication(I-690) | Aug 21, 2017 |
| New Indication(I-691) | Aug 21, 2017 |
| New Chemical Entity Exclusivity(NCE) | Dec 28, 2017 |
Several oppositions have been filed on Eliquis's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Eliquis's generic, the next section provides detailed information on ongoing and past EP oppositions related to Eliquis patents.
Eliquis's Oppositions Filed in EPO
Eliquis has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 14, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP11707284A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17175864A | Aug, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Intas Pharmaceuticals Ltd. | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Wittkopp, Alexander | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | von Seebach, Malte | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Kutzenberger Wolff & Partner | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Teva Pharmaceutical Industries LTD. | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Zentiva k.s. | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | Krka, d.d., Novo mesto | Granted and Under Opposition |
| EP17175864A | Aug, 2020 | SANDOZ AG | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Sandoz AG | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Intas Pharmaceuticals Ltd. | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Intas Pharmaceuticals Ltd. | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Sandoz AG | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Medichem S.A. | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Medichem S.A. | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Kutzenberger Wolff & Partner | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Zentiva k.s. | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | Kutzenberger Wolff & Partner | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | Zentiva k.s. | Granted and Under Opposition |
| EP17178613A | Jul, 2020 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP17175788A | Jul, 2020 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP15190823A | Sep, 2019 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP15190823A | Sep, 2019 | Intas Pharmaceuticals Ltd. | Granted and Under Opposition |
| EP15190823A | Sep, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP15190823A | Sep, 2019 | Zentiva, k.s. | Granted and Under Opposition |
| EP15190823A | Sep, 2019 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
| EP15190823A | Sep, 2019 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP15190823A | Aug, 2019 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
| EP15190823A | Aug, 2019 | Sandoz AG | Granted and Under Opposition |
| EP15190823A | Aug, 2019 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP11707284A | Sep, 2016 | STADA Arzneimittel AG | Revoked |
| EP11707284A | Sep, 2016 | Galenicum Health S.L. | Revoked |
| EP11707284A | Sep, 2016 | Generics (U.K.) Limited | Revoked |
| EP11707284A | Sep, 2016 | Hamm&Wittkopp Patentanwälte PartmbB | Revoked |
| EP11707284A | Sep, 2016 | Intas Pharmaceuticals Ltd. | Revoked |
| EP11707284A | Sep, 2016 | LEK Pharmaceuticals d.d. | Revoked |
| EP11707284A | Sep, 2016 | Zentiva k.s. | Revoked |
| EP11707284A | Sep, 2016 | KRKA, d.d., Novo mesto | Revoked |
| EP11707284A | Sep, 2016 | Plougmann Vingtoft a/s | Revoked |
| EP11707284A | Sep, 2016 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Revoked |
| EP11707284A | Sep, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
US patents provide insights into the exclusivity only within the United States, but Eliquis is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Eliquis's family patents as well as insights into ongoing legal events on those patents.
Eliquis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Eliquis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 24, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Eliquis Generic API suppliers:
Apixaban is the generic name for the brand Eliquis. 10 different companies have already filed for the generic of Eliquis, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Eliquis's generic
How can I launch a generic of Eliquis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Eliquis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Eliquis's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Eliquis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg and 5 mg | 28 Dec, 2016 | 25 | 23 Dec, 2019 | 24 Feb, 2031 | Eligible |
Alternative Brands for Eliquis
Eliquis which is used for reducing the risk of stroke and systemic embolism., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Janssen Pharms |
| |||
| Portola Pharms Inc |
| |||
About Eliquis
Eliquis is a drug owned by Bristol Myers Squibb Co Pharmaceutical Research Institute. It is used for reducing the risk of stroke and systemic embolism. Eliquis uses Apixaban as an active ingredient. Eliquis was launched by Bristol Myers Squibb in 2012.
Approval Date:
Eliquis was approved by FDA for market use on 28 December, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Eliquis is 28 December, 2012, its NCE-1 date is estimated to be 28 December, 2016.
Active Ingredient:
Eliquis uses Apixaban as the active ingredient. Check out other Drugs and Companies using Apixaban ingredient
Treatment:
Eliquis is used for reducing the risk of stroke and systemic embolism.
Dosage:
Eliquis is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 2.5MG | TABLET | Prescription | ORAL |