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 twelve 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 six 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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Summary for XTAMPZA ER
| International Patents: | 24 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 24 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,901 |
| Drug Prices: | Drug price information for XTAMPZA ER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XTAMPZA ER |
| DailyMed Link: | XTAMPZA ER at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XTAMPZA ER
*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
| Sponsor | Phase |
|---|---|
| Collegium Pharmaceutical, Inc. | Phase 4 |
| University of Alabama at Birmingham | Early Phase 1 |
| Ajay Wasan, MD, Msc | Phase 4 |
Pharmacology for XTAMPZA ER
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
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 twelve US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XTAMPZA ER is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-deterrent drug formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-deterrent drug formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-deterrent drug formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-004 | Apr 26, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | RX | Yes | Yes | ⤷ 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 XTAMPZA ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-001 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-001 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XTAMPZA ER
See the table below for patents covering XTAMPZA ER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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) | ⤷ Sign Up |
| European Patent Office | 3326617 | ⤷ Sign Up | |
| Cyprus | 1119831 | ⤷ Sign Up | |
| Australia | 2003247876 | ⤷ Sign Up | |
| Hungary | E037643 | ⤷ Sign Up | |
| Japan | 2015166402 | ⤷ Sign Up | |
| Canada | 2491572 | COMPOSITIONS PHARMACEUTIQUES EMPECHANT LA CONSOMMATION ABUSIVE D'OPIOIDES ET D'AUTRES DROGUES (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIODS AND OTHER DRUGS) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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.
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