Methylin is a drug owned by Specgx Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 07, 2024. Details of Methylin'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). | |||
| US7691880 | Methylphenidate solution and associated methods of administration and production |
Oct, 2024
(a month 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 Methylin's patents.
Latest Legal Activities on Methylin's Patents
Given below is the list of recent legal activities going on the following patents of Methylin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Oct, 2021 | US7691880 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Oct, 2017 | US7691880 |
| Recordation of Patent Grant Mailed Critical | 06 Apr, 2010 | US7691880 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Apr, 2010 | US7691880 |
| Issue Notification Mailed Critical | 17 Mar, 2010 | US7691880 |
| Dispatch to FDC | 01 Mar, 2010 | US7691880 |
| Application Is Considered Ready for Issue Critical | 25 Feb, 2010 | US7691880 |
| Issue Fee Payment Verified Critical | 18 Feb, 2010 | US7691880 |
| Issue Fee Payment Received Critical | 18 Feb, 2010 | US7691880 |
| Mail Notice of Allowance Critical | 26 Jan, 2010 | US7691880 |
US patents provide insights into the exclusivity only within the United States, but Methylin 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 Methylin's family patents as well as insights into ongoing legal events on those patents.
Methylin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Methylin's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 07, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Methylin Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Methylin. 42 different companies have already filed for the generic of Methylin, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Methylin's generic
How can I launch a generic of Methylin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Methylin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Methylin'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 Methylin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/5 mL 10 mg/5 mL | 13 Apr, 2010 | 1 | 23 Jul, 2010 | 07 Oct, 2024 | Eligible |
Alternative Brands for Methylin
There are several other brand drugs using the same active ingredient (Methylphenidate Hydrochloride) as Methylin. 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 |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Methylphenidate Hydrochloride, Methylin's active ingredient. Check the complete list of approved generic manufacturers for Methylin
About Methylin
Methylin is a drug owned by Specgx Llc. Methylin uses Methylphenidate Hydrochloride as an active ingredient. Methylin was launched by Specgx Llc in 2002.
Approval Date:
Methylin was approved by FDA for market use on 19 December, 2002.
Active Ingredient:
Methylin uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Dosage:
Methylin is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/5ML | SOLUTION | Prescription | ORAL |
| 10MG/5ML | SOLUTION | Prescription | ORAL |