Generic Xtampza ER Availability

Last updated on Dec 12, 2024.

Xtampza ER is a brand name of oxycodone, approved by the FDA in the following formulation(s):

XTAMPZA ER (oxycodone - capsule, extended release;oral)

Manufacturer: COLLEGIUM PHARM INC
Approval date: April 26, 2016
Strength(s): 9MG ^[RLD], 13.5MG ^[RLD], 18MG ^[RLD], 27MG ^[RLD], 36MG ^[RLD]

Has a generic version of Xtampza ER been approved?

No. There is currently no therapeutically equivalent version of Xtampza ER available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xtampza ER. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent 10,004,729
Issued: June 26, 2018
Inventor(s): Rariy Roman V. & Fleming Alison & Hirsh Jane C. & Saim Said & Varanasi Ravi K.
Assignee(s): COLLEGIUM PHARMACEUTICAL, INC.
Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Patent expiration dates:
- December 10, 2030
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product
Process of making stable abuse-deterrent oral formulations
Patent 10,188,644
Issued: January 29, 2019
Inventor(s): Saim Said & Fleming Alison B. & Varanasi Ravi K.
Assignee(s): COLLEGIUM PHARMACEUTICAL, INC
The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Patent expiration dates:
- September 2, 2036
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product
Process of making stable abuse-deterrent oral formulations
Patent 10,646,485
Issued: May 12, 2020
Inventor(s): Saim Said & Fleming Alison B. & Varanasi Ravi K.
Assignee(s): Collegium Pharmaceutical, Inc.
The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Patent expiration dates:
- September 2, 2036
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product
Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent 10,668,060
Issued: June 2, 2020
Inventor(s): Rariy Roman V. & Fleming Alison & Hirsh Jane C. & Saim Said & Varanasi Ravi K.
Assignee(s): Collegium Pharmaceutical, Inc.
Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Patent expiration dates:
- December 10, 2030
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product
Patent 7,399,488
Patent expiration dates:
- March 24, 2025
  ✓
  Drug product
Patent 7,771,707
Patent expiration dates:
- March 24, 2025
  ✓
  Drug product
Abuse-deterrent drug formulations
Patent 8,449,909
Issued: May 28, 2013
Inventor(s): Hirsh Jane & Fleming Alison & Rariy Roman & Kilbanov Alexander
Assignee(s): Collegium Pharmaceutical, Inc.
An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.
Patent expiration dates:
- March 24, 2025
  ✓
  Drug product
Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent 8,557,291
Issued: October 15, 2013
Inventor(s): Rariy Roman V. & Fleming Alison B. & Hirsh Jane & Klibanov Alexander M.
Assignee(s): Collegium Pharmaceutical, Inc.
An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In a preferred embodiment, a drug is modified to increase its lipophilicity. In some embodiments the modified drug is homogeneously dispersed within spherical microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and/or organic solvent insoluble. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Patent expiration dates:
- March 21, 2025
  ✓
  Drug product
Abuse-deterrent drug formulations
Patent 8,758,813
Issued: June 24, 2014
Inventor(s): Hirsh Jane & Fleming Alison & Rariy Roman & Klibanov Alexander M.
Assignee(s): Collegium Pharmaceutical, Inc.
An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In one embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.
Patent expiration dates:
- June 10, 2025
  ✓
  Patent 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 9,682,075
Issued: June 20, 2017
Inventor(s): Rariy Roman & Fleming Alison & Hirsh Jane C. & Saim Said & Varanasi Ravi K.
Assignee(s): COLLEGIUM PHARMACEUTICAL, INC.
Tamper-resistance pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Patent expiration dates:
- December 10, 2030
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product
Process of making stable abuse-deterrent oral formulations
Patent 9,737,530
Issued: August 22, 2017
Inventor(s): Saim Said & Fleming Alison B. & Varanasi Ravi K.
Assignee(s): COLLEGIUM PHARMACEUTICAL, INC.
The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Patent expiration dates:
- September 2, 2036
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product
Process of making stable abuse-deterrent oral formulations
Patent 9,968,598
Issued: May 15, 2018
Inventor(s): Saim Said & Fleming Alison B. & Varanasi Ravi K.
Assignee(s): Collegium Pharmaceutical, Inc.
The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Patent expiration dates:
- September 2, 2036
  ✓
  Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  ✓
  Drug product

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* High potential for abuse 2

Approval History Drug history at FDA

WADA Class Anti-Doping Classification

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