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Serving leading biopharmaceutical companies globally:

Dow
Daiichi Sankyo
Covington
Citi
Cerilliant
McKinsey
Cipla
Federal Trade Commission
Chinese Patent Office
Fish and Richardson

Generated: January 20, 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-five patents protecting this drug and two Paragraph IV challenges.

This drug has five hundred and fifty-three patent family members in forty-seven countries.

The generic ingredient in HYSINGLA is hydrocodone bitartrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
Summary for HYSINGLA
International Patents:553
US Patents:35
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HYSINGLA at DailyMed
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 206627-003 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 ➤ Subscribe ➤ Subscribe
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 4/15/2015
➤ Subscribe Extended-release Tablets 30 mg, 40 mg, 80 mg, and 100 mg ➤ Subscribe 5/8/2015

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
8,821,929 Tamper resistant dosage forms ➤ Subscribe
8,524,275 Pharmaceutical formulations containing opioid agonist, opioid antagonist and gelling agent ➤ Subscribe
8,951,555 Controlled release hydrocodone formulations ➤ Subscribe
8,114,383 Abuse-proofed dosage form ➤ Subscribe
7,514,100 Controlled release hydrocodone formulations ➤ Subscribe
9,056,107 Controlled release hydrocodone formulations ➤ Subscribe
9,492,392 Tamper resistant dosage forms ➤ Subscribe
9,775,810 Tamper resistant dosage forms ➤ Subscribe
7,776,314 Abuse-proofed dosage system ➤ Subscribe
9,669,022 Controlled release hydrocodone formulations ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for HYSINGLA

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Farmers Insurance
Federal Trade Commission
Johnson and Johnson
Covington
Moodys
Merck
Julphar
McKinsey

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