Ritalin La 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 Nov 01, 2019. Details of Ritalin La'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). | |||
| US6228398 | Multiparticulate modified release composition |
Nov, 2019
(5 years ago) |
Expired
|
| US6635284 | Delivery of multiple doses of medications |
Dec, 2015
(9 years ago) |
Expired
|
| US7431944 | Delivery of multiple doses of medications |
Dec, 2015
(9 years ago) |
Expired
|
| US5837284 | Delivery of multiple doses of medications |
Dec, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ritalin La 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 Ritalin La's family patents as well as insights into ongoing legal events on those patents.
Ritalin La's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ritalin La's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 01, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ritalin La Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Ritalin La. 42 different companies have already filed for the generic of Ritalin La, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ritalin La's generic
How can I launch a generic of Ritalin La before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ritalin La's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ritalin La'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 Ritalin La -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg | 21 May, 2007 | 1 | 01 Nov, 2019 | Extinguished | |
| 20 mg, 30 mg and 40 mg | 21 Aug, 2006 |
Alternative Brands for Ritalin La
Ritalin La which is used for managing Attention Deficit Hyperactivity Disorder (ADHD) symptoms., 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 |
| ||
| Janssen 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, Ritalin La's active ingredient. Check the complete list of approved generic manufacturers for Ritalin La
About Ritalin La
Ritalin La is a drug owned by Sandoz Inc. It is used for managing Attention Deficit Hyperactivity Disorder (ADHD) symptoms. Ritalin La uses Methylphenidate Hydrochloride as an active ingredient. Ritalin La was launched by Sandoz in 2004.
Approval Date:
Ritalin La was approved by FDA for market use on 10 April, 2004.
Active Ingredient:
Ritalin La uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Treatment:
Ritalin La is used for managing Attention Deficit Hyperactivity Disorder (ADHD) symptoms.
Dosage:
Ritalin La is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 40MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 20MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |