Details for New Drug Application (NDA): 204031

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NDA 204031 describes XARTEMIS XR, which is a drug marketed by Mallinckrodt Inc and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XARTEMIS XR profile page.

The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 204031

Tradename:	XARTEMIS XR
Applicant:	Mallinckrodt Inc
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	12

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 11, 2014	TE:		RLD:	Yes
Patent:	7,976,870	Patent Expiration:	Jun 1, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
Patent:	8,372,432	Patent Expiration:	Mar 11, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Patent:	8,377,453	Patent Expiration:	Nov 19, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Expired US Patents for NDA 204031

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014	6,488,962	⤷ Subscribe
>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.