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Last Updated: November 19, 2019

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HYSINGLA ER Drug Profile

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Which patents cover Hysingla Er, and what generic alternatives are available?

Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are thirty-eight patents protecting this drug and two Paragraph IV challenges.

This drug has five hundred and eighty-four patent family members in forty-eight countries.

The generic ingredient in HYSINGLA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Drug patent expirations by year for HYSINGLA ER
Drug Prices for HYSINGLA ER

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Drug Sales Revenue Trends for HYSINGLA ER

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Pharmacology for HYSINGLA ER
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Synonyms for HYSINGLA ER
143-71-5
4,5-Epoxy-3-methoxy-17-methyl-5|A-morphinan-6-one (2R,3R)-2,3-dihydroxybutanedioate (1:1)
9GU1G05Y03
AN-23265
Biocodone
Brocodid longum
C18H21NO3.C4H6O6
Codone
Dicodethal
Dicodrine
Dicotrate
Dihydrocodeinone acid tartrate
Dihydrocodeinone bitartrate
Dihydrocodeinone hydrogen tartrate
Dihydrocodeinone tartrate
DTXSID40162277
EINECS 205-608-1
Hycon
Hydrocodone (+)-bitartrate salt
HYDROCODONE BITARTRATE
Hydrocodone Bitartrate (anhydrous)
Hydrocodone hydrogen tartrate
Hydrokon
Hysingla
LS-92160
Morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl-, tartrate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5alpha)-, (2R,3R)-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5alpha)-, (R-(R*,R*))-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5alpha)-, (theta-(theta,theta))-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5alpha-epoxy-3-methoxy-17-methyl-, tartrate(1:1)
Robidone
Stodcodon
Synkonin
UNII-9GU1G05Y03
Paragraph IV (Patent) Challenges for HYSINGLA ER
Tradename Dosage Ingredient NDA Submissiondate
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-05-08
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-04-15

US Patents and Regulatory Information for HYSINGLA ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX 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

Expired US Patents for HYSINGLA ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Colorcon

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