Concerta is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 12 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 31, 2018. Details of Concerta'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). | |||
|
US6930129 (Pediatric) | Methods and devices for providing prolonged drug therapy |
Jan, 2018
(6 years ago) |
Expired
|
|
US6919373 (Pediatric) | Methods and devices for providing prolonged drug therapy |
Jan, 2018
(6 years ago) |
Expired
|
|
US8163798 (Pediatric) | Methods and devices for providing prolonged drug therapy |
Jan, 2018
(6 years ago) |
Expired
|
|
US8629179 (Pediatric) | Methods and devices for providing prolonged drug therapy |
Jan, 2018
(6 years ago) |
Expired
|
|
US9000038 (Pediatric) | Methods and devices for providing prolonged drug therapy |
Jan, 2018
(6 years ago) |
Expired
|
| US8629179 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
| US6919373 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
| US8163798 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
| US6930129 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
| US9144549 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
| US9000038 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
| US9029416 | Methods and devices for providing prolonged drug therapy |
Jul, 2017
(7 years ago) |
Expired
|
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 Concerta's patents.
Latest Legal Activities on Concerta's Patents
Given below is the list of recent legal activities going on the following patents of Concerta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 27 May, 2024 | US8163798 |
| Maintenance Fee Reminder Mailed Critical | 11 Dec, 2023 | US8163798 |
| Expire Patent Critical | 19 Jun, 2023 | US9029416 |
| Maintenance Fee Reminder Mailed Critical | 02 Jan, 2023 | US9029416 |
| Expire Patent Critical | 21 Feb, 2022 | US8629179 |
| Maintenance Fee Reminder Mailed Critical | 06 Sep, 2021 | US8629179 |
| Expire Patent Critical | 04 Nov, 2019 | US9144549 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Oct, 2019 | US8163798 |
| Maintenance Fee Reminder Mailed Critical | 20 May, 2019 | US9144549 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Nov, 2018 | US9029416 |
FDA has granted several exclusivities to Concerta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Concerta, 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 Concerta.
Exclusivity Information
Concerta holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Concerta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-88) | Nov 04, 2012 |
US patents provide insights into the exclusivity only within the United States, but Concerta 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 Concerta's family patents as well as insights into ongoing legal events on those patents.
Concerta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Concerta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 31, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Concerta Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Concerta. 42 different companies have already filed for the generic of Concerta, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Concerta's generic
How can I launch a generic of Concerta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Concerta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Concerta'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 Concerta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 18 mg*, 27 mg, 36 mg and 54 mg | 19 Jul, 2005 |
Alternative Brands for Concerta
Concerta which is used for treating ADHD in children 6 years of age and older and adolescents., has several other brand drugs using the same active ingredient (Methylphenidate Hydrochloride). 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 | |||
|---|---|---|---|---|
| Aytu Biopharma |
| |||
| Commave Therap |
| |||
| Ironshore Pharms |
| |||
| Nextwave |
| |||
| Nextwave Pharms |
| |||
| Purdue Pharma Lp |
| |||
| Rhodes Pharms |
| |||
| Sandoz |
| |||
| Specgx Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Methylphenidate Hydrochloride, Concerta's active ingredient. Check the complete list of approved generic manufacturers for Concerta
About Concerta
Concerta is a drug owned by Janssen Pharmaceuticals Inc. It is used for treating ADHD in children 6 years of age and older and adolescents. Concerta uses Methylphenidate Hydrochloride as an active ingredient. Concerta was launched by Janssen Pharms in 2000.
Approval Date:
Concerta was approved by FDA for market use on 01 August, 2000.
Active Ingredient:
Concerta uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Treatment:
Concerta is used for treating ADHD in children 6 years of age and older and adolescents.
Dosage:
Concerta is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 27MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 54MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 36MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 18MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |