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Last Updated: February 23, 2020

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ARYMO ER Drug Profile


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Which patents cover Arymo Er, 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. Forty-four suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

US ANDA 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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Drug patent expirations by year for ARYMO ER
Drug Prices for ARYMO ER

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Recent Litigation for ARYMO ER

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District Court Litigation
Case NameDate
Egalet US, Inc. v. Teva Pharmaceuticals USA, Inc.2018-04-04

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Pharmacology for ARYMO ER
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for ARYMO ER
(5alpha,6alpha)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol, hydrogen sulfate (2:1)
1095-53-0
17-methyl-7,8-didehydro-4,5alpha-epoxymorphinan-3,6-diol sulfate (2:1)
178935-96-1
57-27-2 (Parent)
64-31-3
Astramorph
Astramorph PF
Avinza
CHEBI:7003
CHEMBL2096625
DTXSID4023830
Duramorph
Duramorph PF
DY70C97N30
EINECS 200-582-8
Kapanol
l-Morphine sulfate
Morphabond
MorphaBond ER
Morphinan-3,6-alpha-diol, 7,8-didehydro-4, 5-alpha-epoxy-17-methyl-, sulfate
Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl- (5alpha,6alpha)-, sulfate (2:1) (salt)
Morphinan-3,6alpha-diol, 7,8-didehydro-4,5alpha-epoxy-17-methyl-, sulfate (2:1) (salt)
MORPHINE SULFATE
Morphine Sulfate (anhydrous)
Morphine sulfate hydrate
Morphine sulfate salt solution
Morphine sulfate salt solution, 1.0 mg/mL in methanol, drug standard
Morphine sulphate
Morphine sulphate (2:1)
Morphine, hemisulfate
MST-1 Continus
NIH 0001
NIH 10753
NSC 11441
Oramorph SR
SCHEMBL29316
Skenan
UNII-DY70C97N30
Paragraph IV (Patent) Challenges for ARYMO ER
Tradename Dosage Ingredient NDA Submissiondate
ARYMO ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 208603 2017-12-29

US Patents and Regulatory Information for ARYMO ER

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

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