Exelon Patent Expiration

Exelon is a drug owned by Sandoz Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 08, 2019. Details of Exelon'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).
US6316023 TTS containing an antioxidant
Jan, 2019

(5 years ago)

Expired
US6335031 TTS containing an antioxidant
Jan, 2019

(5 years ago)

Expired
US5602176 Phenyl carbamate
Feb, 2014

(10 years ago)

Expired
US4948807 Phenyl carbamates
Aug, 2012

(12 years ago)

Expired


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 Exelon and ongoing litigations to help you estimate the early arrival of Exelon generic.

Exelon's Litigations

Exelon been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 13, 2014, against patent number US6335031. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Novartis AG as the respondent. Click below to track the latest information on how companies are challenging Exelon's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6316023 April, 2014 FWD Entered
(28 Sep, 2015)
Novartis AG Noven Pharmaceuticals, Inc.
US6316023 November, 2014 FWD Entered
(28 Sep, 2015)
Novartis AG Mylan Pharmaceuticals Inc.
US6335031 April, 2014 FWD Entered
(28 Sep, 2015)
Novartis AG Noven Pharmaceuticals, Inc.
US6335031 November, 2014 FWD Entered
(28 Sep, 2015)
Novartis AG Mylan Pharmaceuticals Inc.


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

Exclusivity Information

Exelon holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Exelon's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Strength(NS) Aug 31, 2015
New Patient Population(NPP) Jun 27, 2016

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Exelon's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Exelon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 08, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Exelon Generic API suppliers:

Rivastigmine is the generic name for the brand Exelon. 5 different companies have already filed for the generic of Exelon, with Alvogen having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exelon's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
4.6 mg/24 hr and 9.5 mg/24 hr 27 Apr, 2011 1 08 Jan, 2019 Extinguished
13.3 mg/24 hr 22 Jan, 2013 1 31 Aug, 2015 08 Jan, 2019 Eligible

Alternative Brands for Exelon

Exelon which is used for managing symptoms of Alzheimer's dementia., has several other brand drugs in the same treatment category . 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 Treatment Area
Janssen Pharms
Razadyne Used for treating Alzheimer's dementia.





About Exelon

Exelon is a drug owned by Sandoz Inc. It is used for managing symptoms of Alzheimer's dementia. Exelon uses Rivastigmine as an active ingredient. Exelon was launched by Sandoz in 2007.

Approval Date:

Exelon was approved by FDA for market use on 06 July, 2007.

Active Ingredient:

Exelon uses Rivastigmine as the active ingredient. Check out other Drugs and Companies using Rivastigmine ingredient

Treatment:

Exelon is used for managing symptoms of Alzheimer's dementia.

Dosage:

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

Strength Dosage Form Availability Application Pathway
9.5MG/24HR FILM, EXTENDED RELEASE Prescription TRANSDERMAL
13.3MG/24HR FILM, EXTENDED RELEASE Prescription TRANSDERMAL
4.6MG/24HR FILM, EXTENDED RELEASE Prescription TRANSDERMAL


Exelon Patent Expiration

Exelon is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 27, 2016. Details of Exelon'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).
US5602176 Phenyl carbamate
Feb, 2014

(10 years ago)

Expired
US4948807 Phenyl carbamates
Aug, 2012

(12 years ago)

Expired


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

Exclusivity Information

Exelon holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Exelon's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Strength(NS) Aug 31, 2015
New Patient Population(NPP) Jun 27, 2016

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Exelon's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Exelon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 27, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Exelon Generic API suppliers:

Rivastigmine Tartrate is the generic name for the brand Exelon. 5 different companies have already filed for the generic of Exelon, with Alvogen having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exelon's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1.5 mg, 3 mg, 4.5 mg and 6 mg 21 Apr, 2004 3 22 Oct, 2007 11 Feb, 2014 Eligible
2 mg/mL 05 Nov, 2004 1 11 Feb, 2014 Extinguished

Alternative Brands for Exelon

Exelon which is used for managing symptoms of Alzheimer's dementia., has several other brand drugs in the same treatment category . 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 Treatment Area
Janssen Pharms
Razadyne Used for treating Alzheimer's dementia.





About Exelon

Exelon is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing symptoms of Alzheimer's dementia. Exelon uses Rivastigmine Tartrate as an active ingredient. Exelon was launched by Novartis in 2000.

Approval Date:

Exelon was approved by FDA for market use on 21 April, 2000.

Active Ingredient:

Exelon uses Rivastigmine Tartrate as the active ingredient. Check out other Drugs and Companies using Rivastigmine Tartrate ingredient

Treatment:

Exelon is used for managing symptoms of Alzheimer's dementia.

Dosage:

Exelon is available in the following dosage forms - solution form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 2MG BASE/ML SOLUTION Discontinued ORAL