Adderall 12.5 is a drug owned by Teva Womens Health Inc. 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 Jan 06, 2021. Details of Adderall 12.5'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). | |||
|
US6384020 (Pediatric) | Rapid immediate release oral dosage form |
Jan, 2021
(3 years ago) |
Expired
|
| US6384020 | Rapid immediate release oral dosage form |
Jul, 2020
(4 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Adderall 12.5 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 Adderall 12.5's family patents as well as insights into ongoing legal events on those patents.
Adderall 12.5's Family Patents
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Generic Launch
Generic Release Date:
Adderall 12.5's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 06, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adderall 12.5 Generic API suppliers:
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate is the generic name for the brand Adderall 12.5. 29 different companies have already filed for the generic of Adderall 12.5, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Adderall 12.5's generic
How can I launch a generic of Adderall 12.5 before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adderall 12.5's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adderall 12.5'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 Adderall 12.5 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg, 20 mg, 30 mg | 18 Nov, 2009 | 1 | 06 Jul, 2020 | Extinguished | |
| 7.5 mg, 12.5 mg and 15 mg |
Alternative Brands for Adderall 12.5
There are several other brand drugs using the same active ingredient (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) as Adderall 12.5. 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa |
| |||||||
| Teva Womens |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate, Adderall 12.5's active ingredient. Check the complete list of approved generic manufacturers for Adderall 12.5
About Adderall 12.5
Adderall 12.5 is a drug owned by Teva Womens Health Inc. Adderall 12.5 uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as an active ingredient. Adderall 12.5 was launched by Teva Womens in 1996.
Approval Date:
Adderall 12.5 was approved by FDA for market use on 13 February, 1996.
Active Ingredient:
Adderall 12.5 uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as the active ingredient. Check out other Drugs and Companies using Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ingredient
Dosage:
Adderall 12.5 is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |