Arymo Er is a drug owned by Zyla Life Sciences Us Inc. It is protected by 2 US drug patents filed in 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2033. Details of Arymo Er'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). | |||
US9044402 | Abuse-deterrent pharmaceutical compositions for controlled release |
Jul, 2033
(8 years from now) | Active |
US9549899 | Abuse deterrent pharmaceutical compositions for controlled release |
Jul, 2033
(8 years 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 Arymo Er's patents.
Latest Legal Activities on Arymo Er's Patents
Given below is the list of recent legal activities going on the following patents of Arymo Er.
Activity | Date | Patent Number |
---|---|---|
Expire Patent Critical | 10 Jul, 2023 | US9044402 |
Maintenance Fee Reminder Mailed Critical | 23 Jan, 2023 | US9044402 |
Expire Patent Critical | 01 Mar, 2021 | US9549899 |
Maintenance Fee Reminder Mailed Critical | 14 Sep, 2020 | US9549899 |
Payment of Maintenance Fee, 4th Year, Large Entity | 20 Nov, 2018 | US9044402 |
Patent Issue Date Used in PTA Calculation Critical | 24 Jan, 2017 | US9549899 |
Recordation of Patent Grant Mailed Critical | 24 Jan, 2017 | US9549899 |
Email Notification Critical | 05 Jan, 2017 | US9549899 |
Issue Notification Mailed Critical | 04 Jan, 2017 | US9549899 |
Dispatch to FDC | 21 Dec, 2016 | US9549899 |
US patents provide insights into the exclusivity only within the United States, but Arymo Er 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 Arymo Er's family patents as well as insights into ongoing legal events on those patents.
Arymo Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Arymo Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 01, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arymo Er Generic API suppliers:
Morphine Sulfate is the generic name for the brand Arymo Er. 32 different companies have already filed for the generic of Arymo Er, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Arymo Er's generic
How can I launch a generic of Arymo Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Arymo Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Arymo Er'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 Arymo Er -
Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
---|---|---|---|---|---|
15 mg, 30 mg and 60 mg | 29 Dec, 2017 | 1 | 25 Nov, 2017 | Extinguished |
Alternative Brands for Arymo Er
Arymo Er which is used for chronic pain management when other treatment options are ineffective., has several other brand drugs in the same treatment category and using the same active ingredient (Morphine Sulfate). 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 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Bdsi |
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Collegium Pharm Inc |
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Purdue Pharma Lp |
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Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Morphine Sulfate. Given below is the list of those drugs and companies owning them.
Drug Owner | Drug Name | |
---|---|---|
Alpharma Pharms |
| |
Fresenius Kabi Usa |
| |
King Pharms Llc |
| |
Ohemo Life |
| |
Pacira Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Morphine Sulfate, Arymo Er's active ingredient. Check the complete list of approved generic manufacturers for Arymo Er
About Arymo Er
Arymo Er is a drug owned by Zyla Life Sciences Us Inc. It is used for chronic pain management when other treatment options are ineffective. Arymo Er uses Morphine Sulfate as an active ingredient. Arymo Er was launched by Zyla in 2017.
Approval Date:
Arymo Er was approved by FDA for market use on 09 January, 2017.
Active Ingredient:
Arymo Er uses Morphine Sulfate as the active ingredient. Check out other Drugs and Companies using Morphine Sulfate ingredient
Treatment:
Arymo Er is used for chronic pain management when other treatment options are ineffective.
Dosage:
Arymo Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
Strength | Dosage Form | Availability | Application Pathway |
---|---|---|---|
15MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
60MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
30MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |