XARTEMIS XR Drug Patent Profile
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Which patents cover Xartemis Xr, and what generic alternatives are available?
Xartemis Xr is a drug marketed by Mallinckrodt Inc and is included in one NDA. There are twelve patents protecting this drug.
This drug has thirty-one patent family members in thirteen countries.
The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Xartemis Xr
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (acetaminophen; oxycodone hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for XARTEMIS XR
| International Patents: | 31 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 2 |
| Patent Applications: | 11 |
| Drug Prices: | Drug price information for XARTEMIS XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XARTEMIS XR |
| DailyMed Link: | XARTEMIS XR at DailyMed |
See drug prices for XARTEMIS XR
Recent Clinical Trials for XARTEMIS XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mallinckrodt | Phase 4 |
| Lotus Clinical Research, LLC | Phase 4 |
US Patents and Regulatory Information for XARTEMIS XR
XARTEMIS XR is protected by twelve US patents.
Patents protecting XARTEMIS XR
Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
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Patent Expiration: ⤷ Sign Up
Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
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Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
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Patent Expiration: ⤷ Sign Up
Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Gastric retentive extended release pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
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Patent Expiration: ⤷ Sign Up
Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
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Patent Expiration: ⤷ Sign Up
Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for XARTEMIS XR
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Premature patent expiration for: XARTEMIS XR
Expiration due to failure to pay maintenance fee
| Patent Number | Tradename | Expiration Date |
|---|---|---|
| ⤷ Sign Up | XARTEMIS XR | ⤷ Sign Up |
International Patents for XARTEMIS XR
See the table below for patents covering XARTEMIS XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 101748906 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2011087765 | ⤷ Sign Up | |
| Canada | 2822553 | PROCEDES DE PRODUCTION DE COMPOSITIONS PHARMACEUTIQUES DOSIFIEES SOLIDES STABILISEES CONTENANT DES MORPHINANES (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS) | ⤷ Sign Up |
| Spain | 2213108 | ⤷ Sign Up | |
| Hong Kong | 1152469 | GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC | ⤷ Sign Up |
| Brazil | 112013015622 | métodos de produção de composições farmacêuticas de dosagem sólida estabilizadas contendo morfinanos | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 03035041 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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