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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 |
| |||
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 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 |
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
Explore Our Curated Drug Screens
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 |
| |||
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 |