Embeda is a drug owned by Alpharma Pharmaceuticals Llc. It is protected by 9 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 07, 2029. Details of Embeda'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). | |||
| US8623418 | Pharmaceutical composition |
Nov, 2029
(4 years from now) | Active |
| US7815934 | Sequestering subunit and related compositions and methods |
Dec, 2027
(2 years from now) | Active |
| US7682634 | Pharmaceutical compositions |
Jun, 2027
(2 years from now) | Active |
| US7682633 | Pharmaceutical composition |
Jun, 2027
(2 years from now) | Active |
| US8158156 | Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist |
Jun, 2027
(2 years from now) | Active |
| US8877247 | Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist |
Jun, 2027
(2 years from now) | Active |
| US8846104 | Pharmaceutical compositions for the deterrence and/or prevention of abuse |
Jun, 2027
(2 years from now) | Active |
| US8685444 | Sequestering subunit and related compositions and methods |
Jul, 2025
(6 months from now) | Active |
| US8685443 | Sequestering subunit and related compositions and methods |
Jul, 2025
(6 months from now) | Active |
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 Embeda's patents.
Latest Legal Activities on Embeda's Patents
Given below is the list of recent legal activities going on the following patents of Embeda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 20 May, 2024 | US8158156 |
| Maintenance Fee Reminder Mailed Critical | 04 Dec, 2023 | US8158156 |
| Expire Patent Critical | 12 Dec, 2022 | US8877247 |
| Expire Patent Critical | 21 Nov, 2022 | US7815934 (Litigated) |
| Expire Patent Critical | 07 Nov, 2022 | US8846104 |
| Maintenance Fee Reminder Mailed Critical | 27 Jun, 2022 | US8877247 |
| Maintenance Fee Reminder Mailed Critical | 06 Jun, 2022 | US7815934 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 23 May, 2022 | US8846104 |
| Expire Patent Critical | 25 Apr, 2022 | US7682633 (Litigated) |
| Expire Patent Critical | 25 Apr, 2022 | US7682634 (Litigated) |
FDA has granted several exclusivities to Embeda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Embeda, 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 Embeda.
Exclusivity Information
Embeda holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Embeda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Aug 13, 2012 |
US patents provide insights into the exclusivity only within the United States, but Embeda 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 Embeda's family patents as well as insights into ongoing legal events on those patents.
Embeda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Embeda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 07, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Embeda Generics:
There are no approved generic versions for Embeda as of now.
How can I launch a generic of Embeda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Embeda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Embeda'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 Embeda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/0.8 mg | 16 Aug, 2018 | 1 | 07 Nov, 2029 | Extinguished | |
| 100 mg/4 mg | 03 May, 2010 | 1 | 19 Jun, 2027 | Extinguished | |
| 60 mg/2.4 mg | 25 May, 2010 | 1 | 19 Jun, 2027 | Extinguished | |
| 30 mg/1.2 mg 50 mg/2 mg 80 mg/3.2 mg | 28 May, 2010 | 1 | 19 Jun, 2027 | Extinguished |
Alternative Brands for Embeda
Embeda which is used for management of severe chronic pain through long-term opioid treatment., 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 | ||
|---|---|---|---|---|
| Pfizer |
| |||
About Embeda
Embeda is a drug owned by Alpharma Pharmaceuticals Llc. It is used for management of severe chronic pain through long-term opioid treatment. Embeda uses Morphine Sulfate; Naltrexone Hydrochloride as an active ingredient. Embeda was launched by Alpharma Pharms in 2009.
Approval Date:
Embeda was approved by FDA for market use on 13 August, 2009.
Active Ingredient:
Embeda uses Morphine Sulfate; Naltrexone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Morphine Sulfate; Naltrexone Hydrochloride ingredient
Treatment:
Embeda is used for management of severe chronic pain through long-term opioid treatment.
Dosage:
Embeda is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |