Effient is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2013 to 2016 out of which all have expired. Effient's patents have been open to challenges since 12 January, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 02, 2023. Details of Effient's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8569325 (Pediatric) | Method of treatment with coadministration of aspirin and prasugrel |
Jul, 2023
(2 years ago) |
Expired
|
|
US8404703 (Pediatric) | Medicinal compositions containing aspirin |
Jul, 2023
(2 years ago) |
Expired
|
| US8569325 | Method of treatment with coadministration of aspirin and prasugrel |
Jan, 2023
(2 years ago) |
Expired
|
| US8404703 | Medicinal compositions containing aspirin |
Mar, 2022
(3 years ago) |
Expired
|
| US6693115 | Acid addition salts of hydropyridine derivatives |
Jul, 2021
(4 years ago) |
Expired
|
|
US5288726 (Pediatric) | Tetrahydrothienopyridine derivatives, furo and pyrrolo analogs thereof and their preparation and uses for inhibiting blood platelet aggregation |
Oct, 2017
(8 years ago) |
Expired
|
| US5288726 | Tetrahydrothienopyridine derivatives, furo and pyrrolo analogs thereof and their preparation and uses for inhibiting blood platelet aggregation |
Apr, 2017
(8 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 Effient's patents.
Latest Legal Activities on Effient's Patents
Given below is the list of recent legal activities going on the following patents of Effient.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 06 Dec, 2021 | US8569325 |
| Maintenance Fee Reminder Mailed
Critical | 21 Jun, 2021 | US8569325 |
| Expire Patent
Critical | 03 May, 2021 | US8404703 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 16 Nov, 2020 | US8404703 (Litigated) |
| Review Certificate Mailed | 19 Jun, 2019 | US8569325 |
| Review Certificate Mailed | 19 Jun, 2019 | US8404703 (Litigated) |
| Review Certificate | 05 Jun, 2019 | US8569325 |
| Review Certificate | 05 Jun, 2019 | US8404703 (Litigated) |
| Termination or Final Written Decision | 12 Sep, 2016 | US8404703 (Litigated) |
| Termination or Final Written Decision | 12 Sep, 2016 | US8569325 |
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 Effient and ongoing
litigations to
help you estimate the early arrival of Effient generic.
Effient's Litigations
Effient been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 26, 2015, against patent number US8569325. The petitioner Panacea Biotec Ltd., challenged the validity of this patent, with DAIICHI SANKYO COMPANY, LIMITED as the respondent. Click below to track the latest information on how companies are challenging Effient's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8404703 | March, 2015 |
Final Written Decision
(12 Sep, 2016) | DAIICHI SANKYO COMPANY, LIMITED et al. | Accord Healthcare Inc., USA et al. |
| US8404703 | March, 2015 |
FWD Entered
(12 Sep, 2016) | DAIICHI SANKYO COMPANY, LIMITED | Accord Healthcare Inc., USA |
| US8404703 | October, 2015 |
Final Written Decision
(12 Sep, 2016) | Daiichi Sankyo Co., Ltd. et al. | Lupin, Ltd. et al. |
| US8404703 | October, 2015 |
FWD Entered
(12 Sep, 2016) | Daiichi Sankyo Co., Ltd. | Lupin, Ltd. |
| US8569325 | March, 2015 |
Final Written Decision
(12 Sep, 2016) | DAIICHI SANKYO COMPANY, LIMITED et al. | Accord Healthcare Inc., USA et al. |
| US8569325 | March, 2015 |
FWD Entered
(12 Sep, 2016) | DAIICHI SANKYO COMPANY, LIMITED | Accord Healthcare Inc., USA |
| US8569325 | October, 2015 |
Final Written Decision
(12 Sep, 2016) | Daiichi Sankyo Co., Ltd. et al. | Lupin, Ltd. et al. |
| US8569325 | October, 2015 |
FWD Entered
(12 Sep, 2016) | Daiichi Sankyo Co., Ltd. | Lupin, Ltd. |
| US8404703 | June, 2015 |
Institution Denied
(07 Jan, 2016) | DAIICHI SANKYO COMPANY, LIMITED et al. | Panacea Biotec Ltd. |
| US8404703 | June, 2015 |
Terminated-Denied
(07 Jan, 2016) | DAIICHI SANKYO COMPANY, LIMITED | Panacea Biotec Ltd. |
| US8569325 | June, 2015 |
Institution Denied
(07 Jan, 2016) | DAIICHI SANKYO COMPANY, LIMITED et al. | Panacea Biotec Ltd. |
| US8569325 | June, 2015 |
Terminated-Denied
(07 Jan, 2016) | DAIICHI SANKYO COMPANY, LIMITED | Panacea Biotec Ltd. |
FDA has granted some exclusivities to Effient. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Effient,
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
Effient.
Exclusivity Information
Effient holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Effient's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 10, 2014 |
| M(M-182) | Jul 12, 2019 |
| Pediatric Exclusivity(PED) | Jan 12, 2020 |
US patents provide insights into the exclusivity only within the United States, but
Effient 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 Effient's family patents as well as insights into
ongoing legal events
on those patents.
Effient's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Effient's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 02, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Effient Generic API suppliers:
Prasugrel Hydrochloride is the generic name for the brand Effient. 10 different companies have already filed for the generic of Effient, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Effient's generic
How can I launch a generic of Effient before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Effient's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Effient'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 Effient -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 10 Jul, 2013 | 17 | 12 Jul, 2017 | 02 Mar, 2022 | Eligible |
About Effient
Effient is a drug owned by Cosette Pharmaceuticals Inc. It is used for preventing thrombosis and embolisms in patients at risk of thrombotic cardiovascular events. Effient uses Prasugrel Hydrochloride as an active ingredient. Effient was launched by Cosette in 2009.
Approval Date:
Effient was approved by FDA for market use on 10 July, 2009.
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 Effient is 10 July, 2009, its NCE-1 date is estimated to be 12 January, 2019.
Active Ingredient:
Effient uses Prasugrel Hydrochloride as the active ingredient. Check out other Drugs and Companies using Prasugrel Hydrochloride ingredient
Treatment:
Effient is used for preventing thrombosis and embolisms in patients at risk of thrombotic cardiovascular events.
Dosage:
Effient is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | TABLET | Prescription | ORAL |
| EQ 5MG BASE | TABLET | Prescription | ORAL |