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Last Updated: April 1, 2025

OXYCODONE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for oxycodone hydrochloride and what is the scope of patent protection?

Oxycodone hydrochloride is the generic ingredient in five branded drugs marketed by Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma, Sun Pharm Inds Inc, and Protega Pharms, and is included in fifty-two NDAs. There are twenty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxycodone hydrochloride has four hundred and eight patent family members in forty-eight countries.

There are twelve drug master file entries for oxycodone hydrochloride. Thirty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for OXYCODONE HYDROCHLORIDE
Recent Clinical Trials for OXYCODONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Henry Ford Health SystemPhase 4
University of MiamiPhase 3
Murdoch Childrens Research InstitutePhase 4

See all OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free80MGTABLET, EXTENDED RELEASE; ORAL
⤷  Try for Free⤷  Try for Free80MGTABLET, EXTENDED RELEASE; ORAL
⤷  Try for Free⤷  Try for Free40MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OXYCODONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for OXYCODONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for OXYCODONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OXAYDO Tablets oxycodone hydrochloride 5 mg and 7.5 mg 202080 1 2012-02-07
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 20 mg 022272 2 2010-10-29
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 15 mg 022272 1 2010-10-28
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 10 mg 022272 1 2010-10-25
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 30 mg, 60 mg and 80 mg 022272 1 2010-10-18
OXYCONTIN Extended-release Tablets oxycodone hydrochloride 40 mg 022272 1 2010-10-04

US Patents and Regulatory Information for OXYCODONE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-002 Apr 5, 2010 RX Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Rhodes Pharms OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091490-005 Mar 9, 2011 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for OXYCODONE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 ⤷  Try for Free ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 ⤷  Try for Free ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 ⤷  Try for Free ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 ⤷  Try for Free ⤷  Try for Free
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries

International Patents for OXYCODONE HYDROCHLORIDE

CountryPatent NumberTitleEstimated Expiration
Austria E489954 ⤷  Try for Free
Chile 2014001029 ⤷  Try for Free
China 102127086 Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone ⤷  Try for Free
Hong Kong 1133192 TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC ⤷  Try for Free
Ukraine 86411 СПОСОБ ПОЛУЧЕНИЯ ГИДРОХЛОРИДА ОКСИКОДОНА, КОТОРЫЙ СОДЕРЖИТ МЕНЬШЕ 25 МЛН. Ч. 14-ГИДРОКСИКОДЕИНОНА;СПОСІБ ОДЕРЖАННЯ ГІДРОХЛОРИДУ ОКСИКОДОНУ, ЩО МІСТИТЬ МЕНШЕ 25 МЛН. Ч. 14-ГІДРОКСИКОДЕЇНОНУ (Normal;heading 1;heading 2;PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE) ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Supplementary Protection Certificates for OXYCODONE HYDROCHLORIDE

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1685839 92292 Luxembourg ⤷  Try for Free 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
Showing 1 to 1 of 1 entries

Oxycodone Hydrochloride Market Dynamics and Financial Trajectory

Introduction to Oxycodone Hydrochloride

Oxycodone hydrochloride is a potent opioid analgesic prescribed for the management of moderate to severe pain, especially when non-opioid medications are insufficient. It works by binding to opioid receptors in the brain and spinal cord, altering the perception and emotional response to pain[5].

Current Market Size and Projections

The global oxycodone hydrochloride market has been valued at approximately USD 401.63 million in 2022 and is expected to grow significantly over the next few years. By 2030, the market is projected to reach around USD 578.94 million, with a compound annual growth rate (CAGR) of about 4.66% during the forecast period from 2023 to 2030[3][4][5].

Growth Drivers

Several factors are driving the growth of the oxycodone hydrochloride market:

Increasing Surgical Procedures

The rise in the number of surgical procedures worldwide has led to a higher demand for oxycodone hydrochloride as an analgesic opioid to manage post-surgical pain. This trend is expected to continue, contributing significantly to the market's expansion[3][4].

Aging Population and Chronic Pain

The aging population is more susceptible to chronic ailments and pain, which increases the demand for effective pain management solutions. Oxycodone hydrochloride, being a potent opioid, is often prescribed for such cases, thereby driving market growth[1][3].

Improvements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations, particularly the development of controlled-release forms, have enhanced the efficacy and safety of oxycodone hydrochloride. These improvements are attracting more patients and healthcare providers, further boosting market growth[1][4].

Enhanced Patient Care Practices

The emphasis on improving patient care practices, especially in hospitals and other healthcare settings, has led to an increased preference for pain-relieving medications like oxycodone hydrochloride. This shift is expected to continue, supporting market expansion[3].

Market Segmentation

By Type

The market is segmented into controlled-release and immediate-release forms. The controlled-release segment is anticipated to register the fastest CAGR over the analysis period due to its sustained pain relief benefits and reduced risk of abuse[3][4].

By Route of Administration

The oral segment is predicted to lead the market in terms of route of administration, given its ease of use and widespread acceptance in various healthcare settings[4].

By Distribution Channel

Hospitals and retail pharmacies are the primary distribution channels. Hospitals are expected to dominate due to the high volume of surgical procedures and the need for post-operative pain management[4].

By Region

  • North America: This region is expected to hold the highest market revenue share due to advanced healthcare technologies and systems. The U.S. and Canada are key markets within this region[5].
  • Europe: Europe is also projected to grow rapidly, driven by an advanced medical system and increased financial resources among individuals[5].
  • Asia-Pacific: This region is anticipated to register the highest CAGR, driven by a large patient population with chronic ailments and liberal regulations in emerging economies like China and India[4].

Financial Trajectory

The financial trajectory of the oxycodone hydrochloride market is promising, with steady growth anticipated over the forecast period.

  • Revenue Growth: The market is expected to grow from USD 401.63 million in 2022 to USD 578.94 million by 2030, at a CAGR of approximately 4.66%[3][4].
  • Regional Contributions: North America and Europe will continue to be significant contributors to the market revenue, while the Asia-Pacific region will experience the highest growth rate[4][5].

Challenges and Opportunities

Challenges

Despite the growth potential, the market faces challenges such as:

  • Regulatory Scrutiny: Strict regulations and concerns about opioid abuse can impact market growth.
  • Side Effects: The risk of side effects and addiction associated with oxycodone hydrochloride can limit its adoption in some cases[2].

Opportunities

  • Research and Development: Ongoing R&D aimed at improving drug delivery methods and reducing side effects presents opportunities for market expansion.
  • Customized Medications: The growing awareness and demand for customized medications, including oxycodone hydrochloride, offer new avenues for growth[5].

Street Value and Illicit Market

The street value of oxycodone hydrochloride, particularly for illicitly sold prescription painkillers, is significant. Generic oxycodone can cost between $12 to $40 per pill, while brand-name OxyContin can range from $50 to $80 per pill. Factors such as availability, demand, and strength of the drug influence these prices[2].

Key Takeaways

  • The global oxycodone hydrochloride market is projected to grow from USD 401.63 million in 2022 to USD 578.94 million by 2030.
  • The market is driven by increasing surgical procedures, an aging population, and advancements in pharmaceutical formulations.
  • The controlled-release segment and oral route of administration are expected to dominate the market.
  • North America and Europe will be significant contributors, while the Asia-Pacific region will experience the highest growth rate.
  • Ongoing R&D and the demand for customized medications offer opportunities for further market expansion.

FAQs

Q: What is the current market size of the oxycodone hydrochloride market? A: The global oxycodone hydrochloride market was valued at approximately USD 401.63 million in 2022[3][4].

Q: What is the projected growth rate of the oxycodone hydrochloride market? A: The market is expected to grow at a CAGR of about 4.66% from 2023 to 2030[3][4].

Q: Which segment is expected to register the fastest CAGR in the oxycodone hydrochloride market? A: The controlled-release segment is anticipated to register the fastest CAGR over the analysis period[3][4].

Q: What are the primary distribution channels for oxycodone hydrochloride? A: Hospitals and retail pharmacies are the primary distribution channels, with hospitals expected to dominate due to high surgical procedure volumes[4].

Q: Which region is expected to register the highest CAGR in the oxycodone hydrochloride market? A: The Asia-Pacific region is anticipated to register the highest CAGR during the forecast period[4].

Sources

  1. Market Research Intellect - Global Oxycodone Hydrochloride Market Size and Projections
  2. Guardian Recovery - What Is the Street Value of Oxycodone?
  3. EIN Presswire - Global Oxycodone Hydrochloride Market Size Scaling New Heights
  4. GlobeNewswire - Global Oxycodone Hydrochloride Market Size Scaling New Heights
  5. InsightAce Analytic - Oxycodone Hydrochloride Market Research Report 2024-2031

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