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Serving leading biopharmaceutical companies globally:

Merck
Argus Health
Daiichi Sankyo
Harvard Business School
Johnson and Johnson
Queensland Health
Federal Trade Commission
McKinsey
Cantor Fitzgerald
Novartis

Generated: October 23, 2017

DrugPatentWatch Database Preview

HYSINGLA Drug Profile

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What is the patent landscape for Hysingla, and what generic Hysingla 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 forty-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 Tradename: HYSINGLA

US Patents:35
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HYSINGLA at DailyMed

Pharmacology for Tradename: HYSINGLA

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
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;ORAL206627-003Nov 20, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-007Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-003Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-002Nov 20, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-001Nov 20, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-005Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-005Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-003Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-004Nov 20, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-005Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: HYSINGLA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-001Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-005Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-004Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-002Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-003Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-007Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-006Nov 20, 2014► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for HYSINGLA

Drugname Dosage Strength RLD Submissiondate
hydrocodone bitartrateExtended-release Tablets20 mg, 60 mg, and 120 mgHysingla ER4/15/2015
hydrocodone bitartrateExtended-release Tablets30 mg, 40 mg, 80 mg, and 100 mgHysingla ER5/8/2015

Non-Orange Book Patents for Tradename: 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
8,894,988Tamper resistant dosage forms► Subscribe
9,278,074Controlled release hydrocodone formulations► Subscribe
9,492,392Tamper resistant dosage forms► Subscribe
9,775,808Tamper resistant dosage forms► Subscribe
8,524,275Pharmaceutical formulations containing opioid agonist, opioid antagonist and gelling agent► Subscribe
7,727,557Pharmaceutical formulation containing irritant► Subscribe
9,056,107Controlled release hydrocodone formulations► Subscribe
9,326,954Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant agent► Subscribe
8,815,289Tamper resistant dosage forms► Subscribe
9,492,393Tamper resistant dosage forms► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: HYSINGLA

Country Document Number Estimated Expiration
South Korea20120105565► Subscribe
Hong Kong1095081► Subscribe
European Patent Office2311459► Subscribe
Israel155637► Subscribe
New Zealand529928► Subscribe
Eurasian Patent Organization023807► Subscribe
Austria499101► Subscribe
Russian Federation2007132975► Subscribe
Denmark2399579► Subscribe
China100518827► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
Boehringer Ingelheim
Daiichi Sankyo
Farmers Insurance
Covington
McKinsey
Colorcon
US Army
US Department of Justice

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 verifification 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.

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