Parsabiv is a drug owned by Kai Pharmaceuticals Inc A Wholly Owned Subsidiary Of Amgen Inc. It is protected by 8 US drug patents filed from 2017 to 2024 out of which none have expired yet. Parsabiv's patents have been open to challenges since 07 February, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 27, 2034. Details of Parsabiv'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. | |||
| US8999932 | Therapeutic agents for reducing parathyroid hormone levels |
Feb, 2031
(6 years from now) | Active |
| US8377880 | Therapeutic agents for reducing parathyroid hormone levels |
Jul, 2030
(5 years from now) | Active |
| US9278995 | Therapeutic agents for reducing parathyroid hormone levels |
Jul, 2030
(5 years from now) | Active |
| US9701712 | Therapeutic agents for reducing parathyroid hormone levels |
Jul, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11162500 | Stable liquid formulation of AMG 416 (etelcalcetide) |
Jun, 2034
(9 years from now) | Active |
| US9820938 | Stable liquid formulation of AMG 416 (etelcalcetide) |
Jun, 2034
(9 years from now) | Active |
| US10344765 | Stable liquid formulation of AMG 416 (etelcalcetide) |
Jun, 2034
(9 years from now) | Active |
| US11959486 | Stable liquid formulation of AMG 416 (etelcalcetide) |
Jun, 2034
(9 years from now) | Active |
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 Parsabiv's patents.
Latest Legal Activities on Parsabiv's Patents
Given below is the list of recent legal activities going on the following patents of Parsabiv.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Aug, 2023 | US9278995 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Dec, 2022 | US10344765 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2022 | US8999932 |
| Recordation of Patent Grant Mailed Critical | 02 Nov, 2021 | US11162500 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Nov, 2021 | US11162500 |
| Email Notification Critical | 14 Oct, 2021 | US11162500 |
| Issue Notification Mailed Critical | 13 Oct, 2021 | US11162500 |
| Application Is Considered Ready for Issue Critical | 04 Oct, 2021 | US11162500 |
| Dispatch to FDC | 04 Oct, 2021 | US11162500 |
| Issue Fee Payment Received Critical | 02 Aug, 2021 | US11162500 |
FDA has granted several exclusivities to Parsabiv. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Parsabiv, 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 Parsabiv.
Exclusivity Information
Parsabiv holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Parsabiv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 07, 2022 |
Several oppositions have been filed on Parsabiv'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 Parsabiv's generic, the next section provides detailed information on ongoing and past EP oppositions related to Parsabiv patents.
Parsabiv's Oppositions Filed in EPO
Parsabiv has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 19, 2018, by Hexal Ag. This opposition was filed on patent number EP14742093A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17160312A | Dec, 2021 | Adalvo Ltd. | Granted and Under Opposition |
| EP17160312A | Dec, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP17160312A | Dec, 2021 | Synthon BV | Granted and Under Opposition |
| EP17160312A | Dec, 2021 | Fresenius Kabi Deutschland GmbH | Granted and Under Opposition |
| EP14742093A | Jan, 2018 | Hexal AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Parsabiv 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 Parsabiv's family patents as well as insights into ongoing legal events on those patents.
Parsabiv's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Parsabiv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 27, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Parsabiv Generics:
There are no approved generic versions for Parsabiv as of now.
How can I launch a generic of Parsabiv before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Parsabiv's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Parsabiv'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 Parsabiv -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL | 08 Feb, 2021 | 2 | 27 Jun, 2034 |
About Parsabiv
Parsabiv is a drug owned by Kai Pharmaceuticals Inc A Wholly Owned Subsidiary Of Amgen Inc. It is used for treating secondary hyperparathyroidism. Parsabiv uses Etelcalcetide as an active ingredient. Parsabiv was launched by Kai Pharms Inc in 2017.
Approval Date:
Parsabiv was approved by FDA for market use on 07 February, 2017.
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 Parsabiv is 07 February, 2017, its NCE-1 date is estimated to be 07 February, 2021.
Active Ingredient:
Parsabiv uses Etelcalcetide as the active ingredient. Check out other Drugs and Companies using Etelcalcetide ingredient
Treatment:
Parsabiv is used for treating secondary hyperparathyroidism.
Dosage:
Parsabiv is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION | Prescription | INTRAVENOUS |
| 10MG/2ML (5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 5MG/ML (5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |