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Last Updated: December 5, 2020

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HYSINGLA ER Drug 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 thirty-eight patents protecting this drug and two Paragraph IV challenges.

This drug has six hundred and four patent family members in forty-nine countries.

The generic ingredient in HYSINGLA ER 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.

US ANDA 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.

  Start Trial

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 Y   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   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   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 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 206627-006 Nov 20, 2014   Start Trial   Start Trial
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 206627-004 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014   Start Trial   Start Trial
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 206627-007 Nov 20, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HYSINGLA ER

Country Patent Number Estimated Expiration
South Korea 20040025741   Start Trial
World Intellectual Property Organization (WIPO) 2008023261   Start Trial
China 102688241   Start Trial
European Patent Office 1515702   Start Trial
African Regional IP Organization (ARIPO) 3815   Start Trial
Guatemala 201300166   Start Trial
Brazil 122018068298   Start Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
McKinsey
Boehringer Ingelheim
McKesson
Harvard Business School

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