RYZOLT Drug Patent Profile

When do Ryzolt patents expire, and what generic alternatives are available?

Ryzolt is a drug marketed by Purdue Pharma and is included in one NDA.

The generic ingredient in RYZOLT is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ryzolt

A generic version of RYZOLT was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

Summary for RYZOLT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	1
Patent Applications:	3,669
What excipients (inactive ingredients) are in RYZOLT?	RYZOLT excipients list
DailyMed Link:	RYZOLT at DailyMed

Recent Clinical Trials for RYZOLT

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2

See all RYZOLT clinical trials

Paragraph IV (Patent) Challenges for RYZOLT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZOLT	Extended-release Tablets	tramadol hydrochloride	100 mg, 200 mg and 300 mg	021745	1	2009-06-18

US Patents and Regulatory Information for RYZOLT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008		DISCN	Yes	No
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008		DISCN	Yes	No
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008		DISCN	Yes	No

Expired US Patents for RYZOLT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008

International Patents for RYZOLT

See the table below for patents covering RYZOLT around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	314124
Germany	69429710
Australia	3995797
Portugal	1594460

Supplementary Protection Certificates for RYZOLT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

RYZOLT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tramadol (Including Ryzolt)

Introduction to Tramadol

Tramadol, a synthetic opioid pain reliever, is widely used to manage mild to moderately severe pain associated with various acute and chronic conditions such as osteoarthritis, post-operative pain, dental pain, neuropathic pain, and cancer. One of the brand names for tramadol is Ryzolt, which is a extended-release formulation.

Global Market Size and Growth

The global tramadol market has been experiencing steady growth. As of 2023, the market size was valued at USD 2.11 billion and is projected to grow to USD 3.50 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period[1][4].

Regional Market Dominance

North America dominated the tramadol market in 2023, with a market share of 49.76%. This dominance is attributed to the high prevalence of chronic pain conditions and the extensive use of pain management drugs in this region[1].

Drivers of Market Growth

Rise in Chronic Diseases and Surgeries

The increasing prevalence of chronic diseases and the growing number of surgeries are significant drivers of the tramadol market. These factors lead to a higher demand for effective pain management solutions, thereby boosting the market growth[1][4].

Regulatory Approvals for New Indications

The market has seen a rise in regulatory approvals for new indications of tramadol, which expands its utility and taps into unmet medical needs. Each new approval signifies a strategic expansion and contributes to the market's growth[1].

Research and Development Initiatives

Research and development initiatives aimed at developing novel formulations and improving delivery efficacy are also driving the market. These initiatives result in the launch of new pain relief products, further expanding the market[1].

Market Challenges

Adverse Events Associated with Tramadol

Despite its benefits, tramadol is associated with adverse events such as addiction, nausea, and dizziness, which can restrict market growth. These side effects necessitate careful prescribing and monitoring, which can impact the drug's adoption rate[1].

Competitive Landscape

The tramadol market is characterized by a fragmented structure with several key players. Companies like Grünenthal, Zydus Group, and GSK plc hold significant market positions due to their established brand presence and strong strategic partnerships with healthcare settings. Other notable players include Mundipharma International, Vertical Pharmaceuticals, LLC, Janssen Global Services, LLC, and Cipher Pharmaceuticals Inc.[1].

Financial Performance of Key Players

While specific financial data for Ryzolt (a brand of tramadol) is not readily available, the financial performance of pharmaceutical companies involved in the pain management sector can provide insights.

• Revenue and Market Share: Companies like Grünenthal and Zydus Group, which are major players in the tramadol market, generate significant revenue from their pain management portfolios. The market share of these companies is substantial, reflecting their strong presence in the global market[1].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the tramadol market, particularly during the initial phases. The decrease in patient visits for conditions like neuropathic pain, dental pain, and osteoarthritis, along with the reduction in elective and non-elective surgeries, led to a decrease in tramadol prescriptions. However, the market rebounded to pre-pandemic levels in 2022 and is expected to experience moderate growth throughout the forecast period[1].

Regional Growth Prospects

Asia Pacific

The Asia Pacific region is anticipated to see lucrative growth due to the increasing aging population and the prevalence of chronic disorders and injuries. Growing disposable income levels in countries like China and India, along with increased investments by major pharmaceutical companies, will stimulate market growth in this region[1][4].

Key Takeaways

• The global tramadol market is expected to grow from USD 2.22 billion in 2024 to USD 3.50 billion by 2032, with a CAGR of 5.8%.
• North America dominates the market, but the Asia Pacific region is expected to show significant growth.
• Regulatory approvals for new indications and research and development initiatives are key drivers of market growth.
• Adverse events associated with tramadol can restrict market growth.
• Established pharmaceutical companies hold significant market positions due to their brand presence and strategic partnerships.

Frequently Asked Questions (FAQs)

1. What is the current market size of the global tramadol market? The global tramadol market size was USD 2.11 billion in 2023[1].

2. What is the expected growth rate of the tramadol market from 2024 to 2032? The tramadol market is expected to grow at a CAGR of 5.8% from 2024 to 2032[1].

3. Which region dominates the tramadol market? North America dominated the tramadol market with a market share of 49.76% in 2023[1].

4. What are the key drivers of the tramadol market growth? The key drivers include the rise in chronic diseases, increase in surgeries, regulatory approvals for new indications, and research and development initiatives[1].

5. What are the potential challenges for the tramadol market? Adverse events associated with tramadol, such as addiction and other side effects, can restrict market growth[1].

Cited Sources:

1. Fortune Business Insights: Tramadol Market Size, Share, Forecast | Growth Report [2032][1]
2. Verified Market Research: Tramadol Drug Market Size, Share, Trends, Growth And Forecast[4]
3. NCBI: MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs[3]