Sancuso Patent Expiration

Sancuso is a drug owned by Cumberland Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 22, 2025. Details of Sancuso'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).
US7608282 Transdermal granisetron
Jan, 2025

(3 months 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 Sancuso's patents.

Given below is the list of recent legal activities going on the following patents of Sancuso.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 14 Apr, 2021 US7608282 (Litigated)
Change in Power of Attorney (May Include Associate POA) 08 Apr, 2013 US7608282 (Litigated)
Correspondence Address Change 05 Apr, 2013 US7608282 (Litigated)
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 03 Apr, 2013 US7608282 (Litigated)
Post Issue Communication - Certificate of Correction 24 May, 2010 US7608282 (Litigated)
Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue 21 Apr, 2010 US7608282 (Litigated)
Record a Petition Decision of Granted for Patent Term Adjustment after Issue 21 Apr, 2010 US7608282 (Litigated)
Adjustment of PTA Calculation by PTO 20 Apr, 2010 US7608282 (Litigated)
Petition Entered 18 Nov, 2009 US7608282 (Litigated)
Patent Issue Date Used in PTA Calculation 27 Oct, 2009 US7608282 (Litigated)


FDA has granted several exclusivities to Sancuso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sancuso, 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 Sancuso.

Exclusivity Information

Sancuso holds 2 exclusivities. All of its exclusivities have expired in 2011. Details of Sancuso's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) Sep 12, 2011
NE(NE) Sep 12, 2011

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Several oppositions have been filed on Sancuso'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 Sancuso's generic, the next section provides detailed information on ongoing and past EP oppositions related to Sancuso patents.

Sancuso's Oppositions Filed in EPO

Sancuso has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2008, by Boeters & Lieck. This opposition was filed on patent number EP04708393A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP04708393A Apr, 2008 Harrison Goddard Foote Opposition rejected
EP04708393A Apr, 2008 BOETERS & LIECK Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Sancuso 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 Sancuso's family patents as well as insights into ongoing legal events on those patents.

Sancuso's Family Patents

Sancuso has patent protection in a total of 31 countries. It's US patent count contributes only to 8.1% of its total global patent coverage. 9 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 Sancuso.

Family Patents

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Generic Launch

Generic Release Date:

Sancuso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 22, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Sancuso Generics:

There are no approved generic versions for Sancuso as of now.

How can I launch a generic of Sancuso before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Sancuso's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sancuso'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 Sancuso -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
3.1 mg/24 hrs 09 Oct, 2015 1 22 Oct, 2024

Alternative Brands for Sancuso

Sancuso which is used for preventing and treating chemotherapy-induced nausea and vomiting., has several other brand drugs using the same active ingredient (Granisetron). 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
Heron Theraps Inc
Sustol
Roche
Kytril






About Sancuso

Sancuso is a drug owned by Cumberland Pharmaceuticals Inc. It is used for preventing and treating chemotherapy-induced nausea and vomiting. Sancuso uses Granisetron as an active ingredient. Sancuso was launched by Cumberland in 2008.

Approval Date:

Sancuso was approved by FDA for market use on 12 September, 2008.

Active Ingredient:

Sancuso uses Granisetron as the active ingredient. Check out other Drugs and Companies using Granisetron ingredient

Treatment:

Sancuso is used for preventing and treating chemotherapy-induced nausea and vomiting.

Dosage:

Sancuso is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
3.1MG/24HR FILM, EXTENDED RELEASE Prescription TRANSDERMAL