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Last Updated: March 3, 2024

HYSINGLA ER Drug Patent Profile


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When do Hysingla Er patents expire, and when can generic versions of Hysingla Er launch?

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

This drug has five hundred and three patent family members in fifty 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hysingla Er

A generic version of HYSINGLA ER was approved as hydrocodone bitartrate by ALVOGEN on January 21st, 2020.

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Paragraph IV (Patent) Challenges for HYSINGLA ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HYSINGLA ER Extended-release Tablets hydrocodone bitartrate 30 mg, 40 mg, 80 mg, and 100 mg 206627 1 2015-05-08
HYSINGLA ER Extended-release Tablets hydrocodone bitartrate 20 mg, 60 mg, and 120 mg 206627 1 2015-04-15

US Patents and Regulatory Information for HYSINGLA ER

HYSINGLA ER is protected by twenty-four US patents.

Patents protecting HYSINGLA ER

Abuse-proofed dosage form
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-proofed dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
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


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-proofed dosage form
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

Encased tamper resistant controlled release dosage forms
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

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
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

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
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

Tamper resistant dosage forms
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

Tamper resistant dosage forms
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

Encased tamper resistant controlled release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-proofed dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Encased tamper resistant controlled release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant controlled release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tamper resistant controlled release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX 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

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 206627-007 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HYSINGLA ER

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

Country Patent Number Title Estimated Expiration
Japan 2005534664 ⤷  Try a Trial
European Patent Office 2826469 Formes posologiques à libération contrôlée enchâssées et inviolables (Encased tamper resistant controlled release dosage forms) ⤷  Try a Trial
Japan 2012229250 TAMPER-RESISTANT ORAL PHARMACEUTICAL DOSAGE FORM COMPRISING OPIOID ANALGESIC ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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