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 active substance 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

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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.

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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 Generics:

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




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.

Market Authorisation 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
30MG TABLET, EXTENDED RELEASE Discontinued ORAL
15MG TABLET, EXTENDED RELEASE Discontinued ORAL
60MG TABLET, EXTENDED RELEASE Discontinued ORAL