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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Chinese Patent Office
Cantor Fitzgerald
McKinsey
Cerilliant
Baxter
Fish and Richardson
Dow

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206627

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NDA 206627 describes HYSINGLA, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are thirty-six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the HYSINGLA profile page.

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.
Summary for 206627
Tradename:HYSINGLA
Applicant:Purdue Pharma Lp
Ingredient:hydrocodone bitartrate
Patents:36
Formulation / Manufacturing:see details
Pharmacology for NDA: 206627
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 206627
Suppliers and Packaging for NDA: 206627
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 NDA Purdue Pharma LP 59011-271 N 59011-271-60
HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 NDA Purdue Pharma LP 59011-272 N 59011-272-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Nov 20, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 30, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Patent:➤ Sign UpPatent Expiration:Nov 20, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Patent:➤ Sign UpPatent Expiration:Oct 30, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 206627

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 206627-002 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
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Argus Health
Chubb
McKinsey
Queensland Health
Covington
Harvard Business School
Daiichi Sankyo
Medtronic

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