Oxycontin Patent Expiration

Oxycontin is a drug owned by Purdue Pharma Lp. It is protected by 32 US drug patents filed from 2013 to 2024. Out of these, 22 drug patents are active and 10 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 29, 2030. Details of Oxycontin's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US9522919 Oxycodone compositions
Mar, 2025

(5 months from now)

Active
US9073933 Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Mar, 2025

(5 months from now)

Active
US10407434 Process for preparing oxycodone compositions
Mar, 2025

(5 months from now)

Active
US10696684 Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Mar, 2025

(5 months from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8894987 Tamper resistant dosage forms
Mar, 2030

(5 years from now)

Active
US9775808 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US9492392 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US8808741 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US9763933 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US11304909 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US11964056 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US9492391 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US8894988 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US9492393 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US11304908 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US9770416 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US9492389 Tamper resistant dosage forms
Aug, 2027

(2 years from now)

Active
US7776314 Abuse-proofed dosage system
Apr, 2025

(5 months from now)

Active
US12060361 Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Mar, 2025

(5 months from now)

Active
US7674799 Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Mar, 2025

(5 months from now)

Active
US7683072 Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Mar, 2025

(5 months from now)

Active
US7674800 Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Mar, 2025

(5 months from now)

Active
US8114383 Abuse-proofed dosage form
Oct, 2024

(14 days ago)

Expired
US8309060 Abuse-proofed dosage form
Nov, 2023

(11 months ago)

Expired
US10130591 Abuse-proofed dosage form
Nov, 2023

(11 months ago)

Expired
US10675278 Crush resistant delayed-release dosage forms
Nov, 2023

(11 months ago)

Expired
US9675610 Abuse-proofed dosage form
Jun, 2023

(1 year, 4 months ago)

Expired
US10369109 Abuse-proofed dosage form
Jun, 2023

(1 year, 4 months ago)

Expired
US8337888 Pharmaceutical formulation containing gelling agent
Aug, 2022

(2 years ago)

Expired
US9060976 Pharmaceutical formulation containing gelling agent
Aug, 2022

(2 years ago)

Expired
US6488963 Hot-melt extrudable pharmaceutical formulation
Jun, 2017

(7 years ago)

Expired
US5508042 Controlled release oxycodone compositions
Apr, 2013

(11 years 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 Oxycontin's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 15 Jul, 2024 US10675278
Maintenance Fee Reminder Mailed 01 Jul, 2024 US8309060
Electronic Review 07 Jun, 2024 US11964056
Payment of Maintenance Fee, 8th Year, Large Entity 22 May, 2024 US9522919 (Litigated)
Email Notification 23 Apr, 2024 US11964056
Mail Patent eGrant Notification 23 Apr, 2024 US11964056
Patent eGrant Notification 23 Apr, 2024 US11964056
Recordation of Patent eGrant 23 Apr, 2024 US11964056
Patent Issue Date Used in PTA Calculation 23 Apr, 2024 US11964056
Recordation of Patent Grant Mailed 23 Apr, 2024 US11964056


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Oxycontin and ongoing litigations to help you estimate the early arrival of Oxycontin generic.

Oxycontin's Litigations

Oxycontin been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 11, 2016, against patent number US9060976. The petitioner Amneal Pharmaceuticals, LLC, challenged the validity of this patent, with PURDUE PHARMA L.P. as the respondent. Click below to track the latest information on how companies are challenging Oxycontin's patents.

Last updated on October 22, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9492392 February, 2018 Terminated-Settled
(21 Aug, 2018)
Purdue Pharma L.P. Kashiv Pharma, LLC
US9492393 February, 2018 Terminated-Settled
(21 Aug, 2018)
Purdue Pharma L.P. Kashiv Pharma, LLC
US9060976 May, 2016 FWD Entered
(08 Nov, 2017)
PURDUE PHARMA L.P. Amneal Pharmaceuticals, LLC


FDA has granted some exclusivities to Oxycontin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oxycontin, 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 Oxycontin.

Exclusivity Information

Oxycontin holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Oxycontin's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-153) Apr 16, 2016
New Patient Population(NPP) Aug 13, 2018

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Several oppositions have been filed on Oxycontin's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Oxycontin's generic, the next section provides detailed information on ongoing and past EP oppositions related to Oxycontin patents.

Oxycontin's Oppositions Filed in EPO

Oxycontin has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 14, 2007, by Purdue Pharma Lp. This opposition was filed on patent number EP04763834A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP06706682A Dec, 2017 G. L. Pharma GmbH Revoked
EP11186168A Oct, 2016 James Poole Limited Opposition rejected
EP10011792A Oct, 2015 Hoffmann Eitle Granted and Under Opposition
EP10011792A Oct, 2015 Setna, Rohan P. Granted and Under Opposition
EP10011792A Oct, 2015 James Poole Limited Granted and Under Opposition
EP10011792A Oct, 2015 Acino Pharma AG Granted and Under Opposition
EP05730345A Dec, 2011 Actavis group PTC ehf Patent maintained as amended
EP05730345A Dec, 2011 Acino Pharma AG Patent maintained as amended
EP05730345A Dec, 2011 Elend, Almut Susanne Patent maintained as amended
EP2005006983W Oct, 2009 Sanofi-Aventis Deutschland GmbH Patent maintained as amended
EP2005006983W Oct, 2009 Ypsomed AG Patent maintained as amended
EP04763833A Mar, 2008 Purdue Pharma LP Opposition rejected
EP04763834A Dec, 2007 Purdue Pharma LP Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Oxycontin 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 Oxycontin's family patents as well as insights into ongoing legal events on those patents.

Oxycontin's Family Patents

Oxycontin has patent protection in a total of 50 countries. It's US patent count contributes only to 26.1% of its total global patent coverage. 9 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 Oxycontin.

Family Patents

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Generic Launch

Generic Release Date:

Oxycontin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 29, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Oxycontin Generic API suppliers:

Oxycodone Hydrochloride is the generic name for the brand Oxycontin. 26 different companies have already filed for the generic of Oxycontin, with Epic Pharma Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Oxycontin's generic

Alternative Brands for Oxycontin

Oxycontin which is used for managing moderate to severe pain that requires long-term opioid treatment when other options are inadequate., has several other brand drugs in the same treatment category and using the same active ingredient (Oxycodone Hydrochloride). 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.
Collegium Pharm Inc
Xtampza Er Used for managing severe, chronic pain when other treatment options are insufficient.
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 Hydrochloride)

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


Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxycodone Hydrochloride, Oxycontin's active ingredient. Check the complete list of approved generic manufacturers for Oxycontin





About Oxycontin

Oxycontin is a drug owned by Purdue Pharma Lp. It is used for managing moderate to severe pain that requires long-term opioid treatment when other options are inadequate. Oxycontin uses Oxycodone Hydrochloride as an active ingredient. Oxycontin was launched by Purdue Pharma Lp in 2010.

Approval Date:

Oxycontin was approved by FDA for market use on 05 April, 2010.

Active Ingredient:

Oxycontin uses Oxycodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Oxycodone Hydrochloride ingredient

Treatment:

Oxycontin is used for managing moderate to severe pain that requires long-term opioid treatment when other options are inadequate.

Dosage:

Oxycontin is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
30MG TABLET, EXTENDED RELEASE Prescription ORAL
20MG TABLET, EXTENDED RELEASE Discontinued ORAL
10MG TABLET, EXTENDED RELEASE Prescription ORAL
15MG TABLET, EXTENDED RELEASE Prescription ORAL
40MG TABLET, EXTENDED RELEASE Prescription ORAL
80MG TABLET, EXTENDED RELEASE Prescription ORAL
60MG TABLET, EXTENDED RELEASE Prescription ORAL
160MG TABLET, EXTENDED RELEASE Discontinued ORAL