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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Colorcon
Boehringer Ingelheim
Teva
Express Scripts
Merck
Fish and Richardson
Citi

Generated: June 25, 2018

DrugPatentWatch Database Preview

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-six patents protecting this drug and two Paragraph IV challenges.

This drug has five hundred and fifty-two patent family members in forty-seven 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

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
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 206627-001 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 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 206627-007 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 Submissiondate
➤ Subscribe Extended-release Tablets 20 mg, 60 mg, and 120 mg ➤ Subscribe 2015-04-15
➤ Subscribe Extended-release Tablets 30 mg, 40 mg, 80 mg, and 100 mg ➤ Subscribe 2015-05-08

Non-Orange Book US Patents for HYSINGLA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,975,273 Controlled release hydrocodone formulations ➤ Sign Up
8,323,889 Process for the production of an abuse-proofed solid dosage form ➤ Sign Up
8,894,988 Tamper resistant dosage forms ➤ Sign Up
9,867,783 Pharmaceutical formulation containing gelling agent ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Dow
Boehringer Ingelheim
Citi
Cerilliant
Healthtrust
Fish and Richardson
Argus Health
Fuji

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