Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Medtronic
McKinsey
McKesson

Last Updated: October 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206627

See Plans and Pricing

« Back to Dashboard

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. Two 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)

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 206627-004 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014   Start Trial   Start Trial
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 206627-007 Nov 20, 2014   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Express Scripts
AstraZeneca
Boehringer Ingelheim
Colorcon

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.