Samsca Patent Expiration

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. Samsca's patents have been open to challenges since 19 May, 2013. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8501730 Process for preparing benzazepine compounds or salts thereof
Sep, 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).
US10905694 Pharmaceutical solid preparation comprising benzazepines and production method thereof
Apr, 2030

(5 years from now)

Active
US5753677 Benzoheterocyclic compounds
May, 2015

(9 years ago)

Expired
US5258510 Benzoheterocyclic compounds
Nov, 2012

(11 years ago)

Expired


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

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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

Samsca has patent protection in a total of 24 countries. It's US patent count contributes only to 8.2% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Samsca.

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

Alternative Brands for Samsca

Samsca which is used for treating low levels of sodium in the blood (hyponatremia)., has several other brand drugs using the same active ingredient (Tolvaptan). 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
Otsuka
Jynarque


Apart from brand drugs containing the same ingredient, some generics have also been filed for Tolvaptan, Samsca's active ingredient. Check the complete list of approved generic manufacturers for Samsca





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.

Approval Date:

Samsca was approved by FDA for market use on 19 May, 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 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
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
15MG TABLET Prescription ORAL
30MG TABLET Prescription ORAL