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-one 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 September 30^th, 1992.

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Summary for ARYMO ER

International Patents:	12
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
Patent Applications:	3,492
Drug Prices:	Drug price information for ARYMO ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARYMO ER
DailyMed Link:	ARYMO ER at DailyMed

Drug patent expirations by year for ARYMO ER

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-001	Jan 9, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20150059167	제어된 방출을 위한 남용 제지 약학적 조성물 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)	⤷ Sign Up
New Zealand	704011	Abuse deterrent pharmaceutical compositions for controlled release	⤷ Sign Up
Japan	2015521988	制御放出用乱用防止性医薬組成物	⤷ Sign Up
Brazil	112015000150	composições farmacêuticas dissuasoras de abuso de liberação controlada	⤷ Sign Up
European Patent Office	2877161	COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)	⤷ Sign Up
Hong Kong	1210599	防止濫用的控釋藥物組合物 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ARYMO ER

Paragraph IV (Patent) Challenges for ARYMO ER

Patents protecting ARYMO ER

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