Sensipar is a drug owned by Amgen Inc. It is protected by 6 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 22, 2026. Details of Sensipar'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). | |||
| US9375405 | Rapid dissolution formulation of a calcium receptor-active compound |
Sep, 2026
(1 year, 4 months from now) | Active |
| US7829595 | Rapid dissolution formulation of a calcium receptor-active compound |
Sep, 2026
(1 year, 4 months from now) | Active |
| US6011068 | Calcium receptor-active molecules |
Mar, 2018
(7 years ago) |
Expired
|
| US6313146 | Calcium receptor-active molecules |
Dec, 2016
(8 years ago) |
Expired
|
| US6031003 | Calcium receptor-active molecules |
Dec, 2016
(8 years ago) |
Expired
|
| US6211244 | Calcium receptor-active compounds |
Oct, 2015
(9 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 Sensipar's patents.
Latest Legal Activities on Sensipar's Patents
Given below is the list of recent legal activities going on the following patents of Sensipar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Nov, 2023 | US9375405 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2022 | US7829595 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Dec, 2019 | US9375405 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Apr, 2018 | US7829595 |
| Post Issue Communication - Certificate of Correction | 13 Feb, 2018 | US9375405 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Jun, 2016 | US9375405 |
| Recordation of Patent Grant Mailed Critical | 28 Jun, 2016 | US9375405 |
| Issue Notification Mailed Critical | 08 Jun, 2016 | US9375405 |
| Dispatch to FDC | 25 May, 2016 | US9375405 |
| Application Is Considered Ready for Issue Critical | 25 May, 2016 | US9375405 |
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 Sensipar and ongoing litigations to help you estimate the early arrival of Sensipar generic.
Sensipar's Litigations
Sensipar been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2015, against patent number US7829595. The petitioner , challenged the validity of this patent, with None as the respondent. Click below to track the latest information on how companies are challenging Sensipar's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7829595 | October, 2015 |
Terminated-Denied
(13 Apr, 2016) | ||
FDA has granted some exclusivities to Sensipar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sensipar, 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 Sensipar.
Exclusivity Information
Sensipar holds 6 exclusivities. All of its exclusivities have expired in 2021. Details of Sensipar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-634) | Feb 25, 2014 |
| M(M-101) | Feb 25, 2014 |
| Orphan Drug Exclusivity(ODE) | Feb 25, 2018 |
| Orphan Drug Exclusivity(ODE-8) | Feb 25, 2018 |
| M(M-200) | May 23, 2020 |
| Orphan Drug Exclusivity(ODE-78) | Nov 21, 2021 |
Several oppositions have been filed on Sensipar'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 Sensipar's generic, the next section provides detailed information on ongoing and past EP oppositions related to Sensipar patents.
Sensipar's Oppositions Filed in EPO
Sensipar has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 14, 2013, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP04781429A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17185704A | May, 2021 | PUREN Pharma GmbH & Co. KG | Granted and Under Opposition |
| EP17185704A | Apr, 2021 | Aristo Pharma GmbH | Granted and Under Opposition |
| EP17185704A | Mar, 2021 | TAD Pharma GmbH | Granted and Under Opposition |
| EP18175497A | Dec, 2020 | Hexal AG | Revoked |
| EP18175495A | Dec, 2020 | betapharm Arzneimittel GmbH | Revoked |
| EP18175497A | Dec, 2020 | betapharm Arzneimittel GmbH | Revoked |
| EP17185704A | Nov, 2020 | betapharm Arzneimittel GmbH | Granted and Under Opposition |
| EP18175495A | Jan, 2020 | Accord Healthcare Ltd | Revoked |
| EP18175495A | Jan, 2020 | HGF Limited | Revoked |
| EP18175495A | Jan, 2020 | BIOGARAN | Revoked |
| EP18175495A | Jan, 2020 | Aechter, Bernd | Revoked |
| EP18175495A | Jan, 2020 | Glenmark Pharmaceuticals Europe Ltd | Revoked |
| EP18175499A | Jan, 2020 | HGF Limited | Revoked |
| EP18175499A | Jan, 2020 | Aechter, Bernd | Revoked |
| EP18175499A | Jan, 2020 | Accord Healthcare Ltd | Revoked |
| EP18175497A | Jan, 2020 | BIOGARAN | Revoked |
| EP18175497A | Jan, 2020 | Zentiva, k.s. | Revoked |
| EP18175497A | Jan, 2020 | MAIWALD PATENTANWALTS- UND RECHTSANWALTSGESELLSCHAFT MBH | Revoked |
| EP18175497A | Jan, 2020 | Aechter, Bernd | Revoked |
| EP18175497A | Jan, 2020 | Accord Healthcare | Revoked |
| EP17185704A | Jan, 2020 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP17185704A | Jan, 2020 | BIOGARAN | Granted and Under Opposition |
| EP17185704A | Jan, 2020 | HGF Limited | Granted and Under Opposition |
| EP17185704A | Jan, 2020 | Aechter, Bernd | Granted and Under Opposition |
| EP18175499A | Jan, 2020 | BIOGARAN | Revoked |
| EP18175499A | Jan, 2020 | MAIWALD PATENTANWALTS- UND RECHTSANWALTSGESELLSCHAFT MBH | Revoked |
| EP18175497A | Jan, 2020 | Glenmark Pharmaceuticals Europe Ltd | Revoked |
| EP18175497A | Jan, 2020 | Gillard, Richard Edward | Revoked |
| EP18175497A | Jan, 2020 | HGF Limited | Revoked |
| EP18175499A | Jan, 2020 | Hamm&Wittkopp Patentanwälte PartmbB | Revoked |
| EP18175499A | Jan, 2020 | Gillard, Richard Edward | Revoked |
| EP18175499A | Jan, 2020 | Glenmark Pharmaceuticals Europe Ltd | Revoked |
| EP17185704A | Jan, 2020 | Glenmark Pharmaceuticals Europe Ltd | Granted and Under Opposition |
| EP17185704A | Jan, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP18175495A | Jan, 2020 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP18175497A | Jan, 2020 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP18175499A | Jan, 2020 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP04781429A | Oct, 2013 | ZBM PATENTS, S.L. | Patent maintained as amended |
| EP04781429A | Oct, 2013 | RAFARM S.A. | Patent maintained as amended |
| EP04781429A | Oct, 2013 | Actavis Group PTC EHF | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Sensipar 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 Sensipar's family patents as well as insights into ongoing legal events on those patents.
Sensipar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sensipar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 22, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sensipar Generic API suppliers:
Cinacalcet Hydrochloride is the generic name for the brand Sensipar. 15 different companies have already filed for the generic of Sensipar, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sensipar's generic
How can I launch a generic of Sensipar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sensipar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sensipar'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 Sensipar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg, 60 mg and 90 mg | 10 Mar, 2008 | 1 | 14 Dec, 2016 | Extinguished |
About Sensipar
Sensipar is a drug owned by Amgen Inc. It is used for treating hyperparathyroidism and hypercalcemia by decreasing parathyroid hormone levels and modulating its secretion. Sensipar uses Cinacalcet Hydrochloride as an active ingredient. Sensipar was launched by Amgen in 2004.
Approval Date:
Sensipar was approved by FDA for market use on 08 March, 2004.
Active Ingredient:
Sensipar uses Cinacalcet Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cinacalcet Hydrochloride ingredient
Treatment:
Sensipar is used for treating hyperparathyroidism and hypercalcemia by decreasing parathyroid hormone levels and modulating its secretion.
Dosage:
Sensipar is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 90MG BASE | TABLET | Discontinued | ORAL |
| EQ 60MG BASE | TABLET | Discontinued | ORAL |
| EQ 30MG BASE | TABLET | Discontinued | ORAL |