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Last Updated: March 28, 2024

ARYMO ER Drug Patent Profile


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When do Arymo Er patents expire, and what generic alternatives are available?

Arymo Er is a drug marketed by Zyla and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in twelve countries.

The generic ingredient in ARYMO ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Arymo Er

A generic version of ARYMO ER was approved as morphine sulfate by HOSPIRA on May 11th, 1988.

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Paragraph IV (Patent) Challenges for ARYMO ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ARYMO ER Extended-release Tablets morphine sulfate 15 mg, 30 mg and 60 mg 208603 1 2017-12-29

US Patents and Regulatory Information for ARYMO ER

ARYMO ER is protected by two US patents.

Patents protecting ARYMO ER

Abuse-deterrent pharmaceutical compositions for controlled release
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Abuse deterrent pharmaceutical compositions for controlled release
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-001 Jan 9, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-002 Jan 9, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-001 Jan 9, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-002 Jan 9, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-003 Jan 9, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-003 Jan 9, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ARYMO ER

See the table below for patents covering ARYMO ER around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2877161 COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE) ⤷  Try a Trial
Canada 2877183 COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS A LIBERATION CONTROLEE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE) ⤷  Try a Trial
Brazil 112015000150 composições farmacêuticas dissuasoras de abuso de liberação controlada ⤷  Try a Trial
Eurasian Patent Organization 201590165 СДЕРЖИВАЮЩИЕ ЗЛОУПОТРЕБЛЕНИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ ⤷  Try a Trial
Japan 2015521988 制御放出用乱用防止性医薬組成物 ⤷  Try a Trial
Hong Kong 1210599 防止濫用的控釋藥物組合物 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.