DrugPatentWatch Database Preview
Email this page to a colleague» See Plans and Pricing
« Back to Dashboard
Hysingla is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are thirty-eight patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in HYSINGLA 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.
There have been thirty-seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (hydrocodone bitartrate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for HYSINGLA
Recent Litigation for HYSINGLA
Identify potential future generic entrants
District Court Litigation
|Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.||2018-06-07|
|Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.||2018-01-11|
|Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC||2018-01-03|
|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||206627-002||Nov 20, 2014||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Purdue Pharma Lp||HYSINGLA ER||hydrocodone bitartrate||TABLET, EXTENDED RELEASE;ORAL||206627-007||Nov 20, 2014||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Purdue Pharma Lp||HYSINGLA ER||hydrocodone bitartrate||TABLET, EXTENDED RELEASE;ORAL||206627-003||Nov 20, 2014||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|