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HYSINGLA Drug Profile

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Hysingla is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are twenty patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and ninety-one patent family members in forty-four 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. There is one tentative approval for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Summary for Tradename: HYSINGLA

Patents:20
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: HYSINGLA

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-004Nov 20, 2014RXNo9,023,401► subscribeY ► subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-006Nov 20, 2014RXNo8,808,740► subscribeY ► subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-003Nov 20, 2014RXNo9,060,940► subscribe ► subscribe
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Paragraph IV activity 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
8,609,683Pharmaceutical formulation containing gelling agent► subscribe
7,332,182Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant► subscribe
8,834,925Tamper 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
Portugal1014941► subscribe
MexicoPA06001452► subscribe
European Patent Office1897545► 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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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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