Samsca is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 4 US drug patents filed from 2013 to 2021. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 07, 2030. Details of Samsca's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8501730 | Process for preparing benzazepine compounds or salts thereof |
Sep, 2026
(2 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5258510 | Benzoheterocyclic compounds |
Nov, 2012
(11 years ago) |
Expired
|
| US5753677 | Benzoheterocyclic compounds |
May, 2015
(9 years ago) |
Expired
|
| US10905694 | Pharmaceutical solid preparation comprising benzazepines and production method thereof |
Apr, 2030
(5 years from now) | Active |
FDA has granted several exclusivities to Samsca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Samsca, 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 Samsca.
Exclusivity Information
Samsca holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Samsca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 19, 2014 |
US patents provide insights into the exclusivity only within the United States, but Samsca 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 Samsca's family patents as well as insights into ongoing legal events on those patents.
Samsca's family patents
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Generic Launch
Generic Release Date:
Samsca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 07, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Samsca Generics:
Tolvaptan is the generic name for the brand Samsca. 5 different companies have already filed for the generic of Samsca, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Samsca's generic
How can I launch a generic of Samsca before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Samsca's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Samsca'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 Samsca -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30mg | 23 Sep, 2013 | 1 | 19 May, 2020 | Extinguished Non-Forfeiture | |
| 15 mg | 10 Oct, 2013 | 1 | 15 Feb, 2022 | 01 Sep, 2026 | Non-Forfeiture |
| 60 mg | 26 Mar, 2018 | 1 | 19 May, 2020 | 01 Sep, 2026 | Eligible |
About Samsca
Samsca is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating low levels of sodium in the blood (hyponatremia). Samsca uses Tolvaptan as an active ingredient. Samsca was launched by Otsuka in 2009.
Market Authorisation Date:
Samsca was approved by FDA for market use on 19 May, 2009.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Samsca is 19 May, 2009, its NCE-1 date is estimated to be 19 May, 2013
Active Ingredient:
Samsca uses Tolvaptan as the active ingredient. Check out other Drugs and Companies using Tolvaptan ingredient
Treatment:
Samsca is used for treating low levels of sodium in the blood (hyponatremia).
Dosage:
Samsca is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET | Prescription | ORAL |
| 30MG | TABLET | Prescription | ORAL |
| 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |