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Xtampza Er Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9968598 Process of making stable abuse-deterrent oral formulations
Sep, 2036

(11 years from now)

Active
US9737530 Process of making stable abuse-deterrent oral formulations
Sep, 2036

(11 years from now)

Active
US10188644 Process of making stable abuse-deterrent oral formulations
Sep, 2036

(11 years from now)

Active
US10646485 Process of making stable abuse-deterrent oral formulations
Sep, 2036

(11 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
US9682075 Tamper-resistant pharmaceutical compositions of opioids and other drugs
Dec, 2030

(6 years from now)

Active
US8758813 Abuse-deterrent drug formulations
Jun, 2025

(6 months from now)

Active
US7399488 Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Mar, 2025

(4 months from now)

Active
US7771707 Abuse-deterrent drug formulations
Mar, 2025

(4 months from now)

Active
US8449909 Abuse-deterrent drug formulations
Mar, 2025

(4 months from now)

Active
US8557291 Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Mar, 2025

(4 months from now)

Active
US8840928 Tamper-resistant pharmaceutical compositions of opioids and other drugs
Jul, 2023

(1 year, 4 months ago)

Expired
US9763883 Abuse-deterrent drug formulations
Jul, 2023

(1 year, 4 months ago)

Expired
US9248195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Jul, 2023

(1 year, 4 months ago)

Expired
US10525053 Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Jul, 2023

(1 year, 4 months ago)

Expired
US10525052 Abuse-deterrent drug formulations
Jul, 2023

(1 year, 4 months ago)

Expired
US9044398 Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Jul, 2023

(1 year, 4 months ago)

Expired
US9592200 Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Jul, 2023

(1 year, 4 months ago)

Expired


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.

Given below is the list of recent legal activities going on the following patents of Xtampza Er.

Activity Date Patent Number
Patent litigations
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
Critical
 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
Critical
 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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

Xtampza Er has patent protection in a total of 13 countries. It has a significant patent presence in the US with 68.3% of its patents being US patents. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Xtampza Er.

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

Alternative Brands for Xtampza Er

Xtampza Er which is used for managing severe, chronic pain when other treatment options are insufficient., has several other brand drugs in the same treatment category and using the same active ingredient (Oxycodone). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Bdsi
Belbuca Used for managing severe, long-term pain when other treatments are insufficient, through transmucosal delivery of buprenorphine.
Purdue Pharma Lp
Butrans Used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy.
Targiniq

(uses Oxycodone)

 Used for managing severe chronic pain when alternative treatment options are inadequate, requiring daily, around-the-clock, long-term opioid treatment.
Oxycontin

(uses Oxycodone)

 used for managing moderate to severe pain that requires long-term opioid treatment when other options are inadequate.
Hysingla Er used for managing severe chronic pain when other treatment options are insufficient.
Zyla
Arymo Er Used for chronic pain management when other treatment options are ineffective.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Oxycodone. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Mallinckrodt Inc
Xartemis Xr
Pfizer
Troxyca Er
Protega Pharms
Roxybond
Zyla
Oxaydo






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.

Approval 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
9MG CAPSULE, EXTENDED RELEASE Prescription ORAL
18MG CAPSULE, EXTENDED RELEASE Prescription ORAL
27MG CAPSULE, EXTENDED RELEASE Prescription ORAL
13.5MG CAPSULE, EXTENDED RELEASE Prescription ORAL
36MG CAPSULE, EXTENDED RELEASE Prescription ORAL