Exalgo is a drug owned by Specgx Llc. 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 Jul 07, 2014. Details of Exalgo'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). | |||
| US5702725 | Hydromorphone therapy |
Jul, 2014
(10 years ago) |
Expired
|
| US5914131 | Hydromorphone therapy |
Jul, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Exalgo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exalgo, 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 Exalgo.
Exclusivity Information
Exalgo holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Exalgo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Mar 01, 2013 |
US patents provide insights into the exclusivity only within the United States, but Exalgo 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 Exalgo's family patents as well as insights into ongoing legal events on those patents.
Exalgo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exalgo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 07, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exalgo Generic API suppliers:
Hydromorphone Hydrochloride is the generic name for the brand Exalgo. 17 different companies have already filed for the generic of Exalgo, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exalgo's generic
How can I launch a generic of Exalgo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Exalgo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Exalgo'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 Exalgo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8 mg and 12 mg | 02 Sep, 2010 | 1 | 12 May, 2014 | 07 Jul, 2014 | Deferred |
| 16 mg | 02 Aug, 2010 | 1 | 12 May, 2014 | 07 Jul, 2014 | Deferred |
Alternative Brands for Exalgo
Exalgo which is used for managing moderate to severe pain., has several other brand drugs using the same active ingredient (Hydromorphone 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 | ||
|---|---|---|---|
| Fresenius Kabi Usa |
| ||
| Purdue Pharma Lp |
| ||
| Rhodes Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydromorphone Hydrochloride, Exalgo's active ingredient. Check the complete list of approved generic manufacturers for Exalgo
About Exalgo
Exalgo is a drug owned by Specgx Llc. It is used for managing moderate to severe pain. Exalgo uses Hydromorphone Hydrochloride as an active ingredient. Exalgo was launched by Specgx Llc in 2010.
Approval Date:
Exalgo was approved by FDA for market use on 01 March, 2010.
Active Ingredient:
Exalgo uses Hydromorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Hydromorphone Hydrochloride ingredient
Treatment:
Exalgo is used for managing moderate to severe pain.
Dosage:
Exalgo is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |