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Last Updated: July 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206627


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

The generic ingredient in HYSINGLA ER 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 ER
Applicant:Purdue Pharma Lp
Ingredient:hydrocodone bitartrate
Patents:38
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 ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 NDA Purdue Pharma LP 59011-271 59011-271-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60)
HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 NDA Purdue Pharma LP 59011-272 59011-272-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60)
Paragraph IV (Patent) Challenges for 206627
Tradename Dosage Ingredient NDA Submissiondate
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-05-08
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-04-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Nov 20, 2014TE:RLD:Yes
Patent:  Start TrialPatent 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:  Start TrialPatent Expiration:Jun 16, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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

Expired US Patents for NDA 206627

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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