Strattera is a drug owned by Eli Lilly And Co. 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 May 26, 2017. Details of Strattera'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). | |||
|
US5658590 (Pediatric) | Treatment of attention-deficit/hyperactivity disorder |
May, 2017
(7 years ago) |
Expired
|
| US5658590 | Treatment of attention-deficit/hyperactivity disorder |
Nov, 2016
(7 years ago) |
Expired
|
FDA has granted several exclusivities to Strattera. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Strattera, 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 Strattera.
Exclusivity Information
Strattera holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Strattera's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-78) | Jul 23, 2011 |
US patents provide insights into the exclusivity only within the United States, but Strattera 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 Strattera's family patents as well as insights into ongoing legal events on those patents.
Strattera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Strattera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 26, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Strattera Generic API suppliers:
Atomoxetine Hydrochloride is the generic name for the brand Strattera. 8 different companies have already filed for the generic of Strattera, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Strattera's generic
How can I launch a generic of Strattera before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Strattera's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Strattera'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 Strattera -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg | 29 May, 2007 | 10 | 30 May, 2017 | 26 Nov, 2016 | Extinguished |
Alternative Brands for Strattera
Strattera which is used for managing symptoms of attention-deficit hyperactivity disorder., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Takeda Pharms Usa |
| |||
About Strattera
Strattera is a drug owned by Eli Lilly And Co. It is used for managing symptoms of attention-deficit hyperactivity disorder. Strattera uses Atomoxetine Hydrochloride as an active ingredient. Strattera was launched by Lilly in 2002.
Approval Date:
Strattera was approved by FDA for market use on 26 November, 2002.
Active Ingredient:
Strattera uses Atomoxetine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Atomoxetine Hydrochloride ingredient
Treatment:
Strattera is used for managing symptoms of attention-deficit hyperactivity disorder.
Dosage:
Strattera is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | CAPSULE | Prescription | ORAL |
| EQ 25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 5MG BASE | CAPSULE | Discontinued | ORAL |
| EQ 10MG BASE | CAPSULE | Prescription | ORAL |
| EQ 60MG BASE | CAPSULE | Prescription | ORAL |
| EQ 80MG BASE | CAPSULE | Prescription | ORAL |
| EQ 100MG BASE | CAPSULE | Prescription | ORAL |
| EQ 18MG BASE | CAPSULE | Prescription | ORAL |