Metadate Cd is a drug owned by Aytu Biopharma Inc. 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 27, 2020. Details of Metadate Cd'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). | |||
| US6344215 | Methylphenidate modified release formulations |
Oct, 2020
(4 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Metadate Cd 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 Metadate Cd's family patents as well as insights into ongoing legal events on those patents.
Metadate Cd's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Metadate Cd's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 27, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Metadate Cd Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Metadate Cd. 42 different companies have already filed for the generic of Metadate Cd, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Metadate Cd's generic
How can I launch a generic of Metadate Cd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Metadate Cd's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Metadate Cd'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 Metadate Cd -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 20 mg and 30 mg | 13 May, 2005 | 1 | 19 Jul, 2012 | 27 Oct, 2020 | Non-Forfeiture |
| 40 mg | 15 Mar, 2007 | 1 | 19 Jul, 2012 | 27 Oct, 2020 | Non-Forfeiture |
Alternative Brands for Metadate Cd
There are several other brand drugs using the same active ingredient (Methylphenidate Hydrochloride) as Metadate Cd. 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 | |||
|---|---|---|---|---|
| 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, Metadate Cd's active ingredient. Check the complete list of approved generic manufacturers for Metadate Cd
About Metadate Cd
Metadate Cd is a drug owned by Aytu Biopharma Inc. Metadate Cd uses Methylphenidate Hydrochloride as an active ingredient. Metadate Cd was launched by Aytu Biopharma in 2003.
Approval Date:
Metadate Cd was approved by FDA for market use on 27 May, 2003.
Active Ingredient:
Metadate Cd uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Dosage:
Metadate Cd is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 40MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |