Xtampza Er is a drug owned by Collegium Pharmaceutical Inc. It is protected by 19 US drug patents filed from 2016 to 2020. Out of these, 12 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 02, 2036. Details of Xtampza Er's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8840928 | Tamper-resistant pharmaceutical compositions of opioids and other drugs |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US9248195 | Abuse-deterrent pharmaceutical compositions of opioids and other drugs |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US10525052 | Abuse-deterrent drug formulations |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US10525053 | Abuse-deterrent pharmaceutical compositions of opioids and other drugs |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US9763883 | Abuse-deterrent drug formulations |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US9592200 | Abuse-deterrent pharmaceutical compositions of opioids and other drugs |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US9044398 | Abuse-deterrent pharmaceutical compositions of opiods and other drugs |
Jul, 2023
(1 year, 21 days ago) |
Expired
|
| US8557291 | Abuse-deterrent pharmaceutical compositions of opioids and other drugs |
Mar, 2025
(7 months from now) | Active |
| US7399488 | Abuse-deterrent pharmaceutical compositions of opiods and other drugs |
Mar, 2025
(7 months from now) | Active |
| US8449909 | Abuse-deterrent drug formulations |
Mar, 2025
(7 months from now) | Active |
| US7771707 | Abuse-deterrent drug formulations |
Mar, 2025
(7 months from now) | Active |
| US8758813 | Abuse-deterrent drug formulations |
Jun, 2025
(10 months from now) | Active |
| US9682075 | Tamper-resistant pharmaceutical compositions of opioids and other drugs |
Dec, 2030
(6 years from now) | Active |
| US10004729 | Tamper-resistant pharmaceutical compositions of opioids and other drugs |
Dec, 2030
(6 years from now) | Active |
| US10668060 | Tamper-resistant pharmaceutical compositions of opioids and other drugs |
Dec, 2030
(6 years from now) | Active |
| US10646485 | Process of making stable abuse-deterrent oral formulations |
Sep, 2036
(12 years from now) | Active |
| US10188644 | Process of making stable abuse-deterrent oral formulations |
Sep, 2036
(12 years from now) | Active |
| US9737530 | Process of making stable abuse-deterrent oral formulations |
Sep, 2036
(12 years from now) | Active |
| US9968598 | Process of making stable abuse-deterrent oral formulations |
Sep, 2036
(12 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Xtampza Er's patents.
Latest Legal Activities on Xtampza Er's Patents
Given below is the list of recent legal activities going on the following patents of Xtampza Er.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 20 Mar, 2024 | US7771707 |
| Second letter to regulating agency to determine regulatory review period | 20 Mar, 2024 | US7399488 |
| Requirement for information sent under 37 CFR 1.750 | 20 Mar, 2024 | US7771707 |
| Second letter to regulating agency to determine regulatory review period | 20 Mar, 2024 | US8449909 |
| Expire Patent | 12 Feb, 2024 | US10525053 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 15 Nov, 2023 | US10668060 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 25 Oct, 2023 | US10646485 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US7399488 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US7771707 |
| Maintenance Fee Reminder Mailed | 28 Aug, 2023 | US10525053 |
FDA has granted several exclusivities to Xtampza Er. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xtampza Er, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xtampza Er.
Exclusivity Information
Xtampza Er holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Xtampza Er's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 26, 2019 |
US patents provide insights into the exclusivity only within the United States, but Xtampza Er is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xtampza Er's family patents as well as insights into ongoing legal events on those patents.
Xtampza Er's family patents
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Generic Launch
Generic Release Date:
Xtampza Er's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 02, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xtampza Er Generics:
There are no approved generic versions for Xtampza Er as of now.
How can I launch a generic of Xtampza Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xtampza Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xtampza Er's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Xtampza Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg | 15 Nov, 2017 | 1 | 02 Sep, 2036 |
About Xtampza Er
Xtampza Er is a drug owned by Collegium Pharmaceutical Inc. It is used for managing severe, chronic pain when other treatment options are insufficient. Xtampza Er uses Oxycodone as an active ingredient. Xtampza Er was launched by Collegium Pharm Inc in 2016.
Market Authorisation Date:
Xtampza Er was approved by FDA for market use on 26 April, 2016.
Active Ingredient:
Xtampza Er uses Oxycodone as the active ingredient. Check out other Drugs and Companies using Oxycodone ingredient
Treatment:
Xtampza Er is used for managing severe, chronic pain when other treatment options are insufficient.
Dosage:
Xtampza Er is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 18MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 9MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 13.5MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 27MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 36MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |