Oxycodone hydrochloride - Generic Drug Details

What are the generic sources for oxycodone hydrochloride and what is the scope of freedom to operate?

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

International Patents:	408
US Patents:	21
Tradenames:	5
Applicants:	31
NDAs:	52
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	575
Patent Applications:	3,193
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxycodone hydrochloride
What excipients (inactive ingredients) are in oxycodone hydrochloride?	oxycodone hydrochloride excipients list
DailyMed Link:	oxycodone hydrochloride at DailyMed

Recent Clinical Trials for oxycodone hydrochloride

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

Sponsor	Phase
Henry Ford Health System	Phase 4
University of Miami	Phase 3
Murdoch Childrens Research Institute	Phase 4

See all oxycodone hydrochloride clinical trials

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL
		80MG	TABLET, EXTENDED RELEASE; ORAL
		40MG	TABLET, 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 Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for oxycodone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	091313-001	Feb 18, 2011		DISCN	No	No
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010		RX	Yes	No	9,492,389		Y
Abhai Llc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	208593-002	Jul 21, 2017	AA	RX	No	No
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010		RX	Yes	No	9,492,393
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No	9,770,416		Y
Specgx Llc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	076758-001	Jun 30, 2004	AB	RX	No	No
Rhodes Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	091490-004	Mar 9, 2011	AB	RX	No	No

Expired US Patents for oxycodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	9,073,933
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010	10,675,278
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010	10,369,109
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010	9,073,933
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	10,407,434
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010	9,522,919
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	10,675,278

International Patents for oxycodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Poland	1730151
Guatemala	200900023	FORMAS FARMACÉUTICAS DE DOSIFICACIÓN ORAL QUE CONTIENEN UN ANALGÉSICO OPIOIDE.
South Korea	20070022033	PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE
China	103861111	TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING OPIOID ANALGESIC
Argentina	124161	CLORHIDRATO DE OXICODONA QUE TIENE 14-HIDROXICODEINONA CON NIVEL INFERIOR A 100 PPM Y FORMA FARMACÉUTICA DE DOSIFICACIÓN QUE LO CONTIENE
Denmark	2399580
Jordan	3323	صور جرعة صيدلانية (Pharmaceutical dosage forms)

Supplementary Protection Certificates for oxycodone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		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

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