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Last Updated: September 27, 2022

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 five 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. 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Pharmaceutical formulation containing gelling agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Encased tamper resistant controlled release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-proofed dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Encased tamper resistant controlled release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant controlled release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper resistant controlled release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
>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
Portugal 1842533 See Plans and Pricing
Malaysia 161079 TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC See Plans and Pricing
New Zealand 608651 Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic See Plans and Pricing
Hong Kong 1138498 TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC See Plans and Pricing
Japan 2014500304 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
McKinsey
Boehringer Ingelheim
McKesson
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.