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Covington
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Generated: May 22, 2019

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HYSINGLA Drug Profile

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

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

This drug has five hundred and seventy-six patent family members in forty-eight countries.

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

Drug patent expirations by year for HYSINGLA
Pharmacology for HYSINGLA
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for HYSINGLA
Synonyms for HYSINGLA
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 ER
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

US Patents and Regulatory Information for HYSINGLA

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 hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 RX 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

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Expired US Patents for HYSINGLA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for HYSINGLA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 30 mg, 40 mg, 80 mg, and 100 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 20 mg, 60 mg, and 120 mg ➤ Subscribe ➤ Sign Up

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Fuji

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