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Last Updated: August 8, 2022

XTAMPZA ER Drug Patent Profile


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Which patents cover Xtampza Er, and when can generic versions of Xtampza Er launch?

Xtampza Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in XTAMPZA ER is oxycodone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxycodone profile page.

DrugPatentWatch® Generic Entry Outlook for Xtampza Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2036. This may change due to patent challenges or generic licensing.

There have been seven 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 are four tentative approvals for the generic drug (oxycodone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for XTAMPZA ER
Drug Prices for XTAMPZA ER

See drug prices for XTAMPZA ER

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XTAMPZA ER
Generic Entry Date for XTAMPZA ER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, 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.

Recent Clinical Trials for XTAMPZA ER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ajay Wasan, MD, MscPhase 4
Collegium Pharmaceutical, Inc.Phase 4
University of Alabama at BirminghamEarly Phase 1

See all XTAMPZA ER clinical trials

Pharmacology for XTAMPZA ER
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for XTAMPZA ER
Paragraph IV (Patent) Challenges for XTAMPZA ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XTAMPZA ER Extended-release Capsules oxycodone 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg 208090 1 2017-11-15

US Patents and Regulatory Information for XTAMPZA ER

XTAMPZA ER is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XTAMPZA ER is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XTAMPZA ER

Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Process of making stable abuse-deterrent oral formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Abuse-deterrent drug formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent drug formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent drug formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent drug formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Process of making stable abuse-deterrent oral formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Abuse-deterrent drug formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process of making stable abuse-deterrent oral formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for XTAMPZA ER

See the table below for patents covering XTAMPZA ER around the world.

Country Patent Number Title Estimated Expiration
Hungary E037643 See Plans and Pricing
Japan 2015166402 オピオイドおよび他の薬物に関する乱用抑止性の薬学的組成物 (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIOIDS AND OTHER DRUGS) See Plans and Pricing
Canada 2569958 FORMULATIONS DE PREVENTION DES ABUS (ABUSE-DETERRENT DRUG FORMULATIONS) See Plans and Pricing
Cyprus 1119831 See Plans and Pricing
Canada 2916869 FORMULATIONS DE PREVENTION DES ABUS (ABUSE-DETERRENT DRUG FORMULATIONS) See Plans and Pricing
Poland 1765292 See Plans and Pricing
European Patent Office 1765292 FORMULATIONS DE PRÉVENTION DES ABUS (ABUSE-DETERRENT DRUG FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XTAMPZA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.