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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 205777


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NDA 205777 describes TARGINIQ, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are fifteen patents protecting this drug. Additional details are available on the TARGINIQ profile page.

The generic ingredient in TARGINIQ is naloxone hydrochloride; oxycodone hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the naloxone hydrochloride; oxycodone hydrochloride profile page.
Summary for 205777
Generic Entry Opportunity Date for 205777
Generic Entry Date for 205777*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;10MG
Approval Date:Jul 23, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 10, 2022Product 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 205777

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-001 Jul 23, 2014   Start Trial   Start Trial
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-001 Jul 23, 2014   Start Trial   Start Trial
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-001 Jul 23, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.