Arymo Er Patent Expiration

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).
US9549899 Abuse deterrent pharmaceutical compositions for controlled release
Jul, 2033

(8 years from now)

Active
US9044402 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.

Given below is the list of recent legal activities going on the following patents of Arymo Er.

Activity Date Patent Number
Patent litigations
Expire Patent 10 Jul, 2023 US9044402
Maintenance Fee Reminder Mailed 23 Jan, 2023 US9044402
Expire Patent 01 Mar, 2021 US9549899
Maintenance Fee Reminder Mailed 14 Sep, 2020 US9549899
Payment of Maintenance Fee, 4th Year, Large Entity 20 Nov, 2018 US9044402
Patent Issue Date Used in PTA Calculation 24 Jan, 2017 US9549899
Recordation of Patent Grant Mailed 24 Jan, 2017 US9549899
Email Notification 05 Jan, 2017 US9549899
Issue Notification Mailed 04 Jan, 2017 US9549899
Dispatch to FDC 21 Dec, 2016 US9549899

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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

Arymo Er has patent protection in a total of 13 countries. It's US patent count contributes only to 23.5% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Arymo Er.

Family Patents

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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
Belbuca Used for managing severe, long-term pain when other treatments are insufficient, through transmucosal delivery of buprenorphine.
Collegium Pharm Inc
Xtampza Er Used for managing severe, chronic pain when other treatment options are insufficient.
Purdue Pharma Lp
Butrans Used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy.
Targiniq Used for managing severe chronic pain when alternative treatment options are inadequate, requiring daily, around-the-clock, long-term opioid treatment.
Oxycontin used for managing moderate to severe pain that requires long-term opioid treatment when other options are inadequate.
Hysingla Er used for managing severe chronic pain when other treatment options are insufficient.

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
Embeda
Fresenius Kabi Usa
Morphine Sulfate
King Pharms Llc
Avinza
Ohemo Life
Morphabond Er
Pacira Pharms Inc
Depodur


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