QDOLO Drug Patent Profile

When do Qdolo patents expire, and when can generic versions of Qdolo launch?

Qdolo is a drug marketed by Athena and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in QDOLO 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 Qdolo

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

Summary for QDOLO

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	2,442
What excipients (inactive ingredients) are in QDOLO?	QDOLO excipients list
DailyMed Link:	QDOLO at DailyMed

Pharmacology for QDOLO

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for QDOLO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QDOLO	Oral Solution	tramadol hydrochloride	5 mg/mL	214044	1	2024-09-16

US Patents and Regulatory Information for QDOLO

QDOLO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Athena	QDOLO	tramadol hydrochloride	SOLUTION;ORAL	214044-001	Sep 1, 2020		DISCN	Yes	No			Y
Athena	QDOLO	tramadol hydrochloride	SOLUTION;ORAL	214044-001	Sep 1, 2020		DISCN	Yes	No			Y

International Patents for QDOLO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021092406

Supplementary Protection Certificates for QDOLO

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

QDOLO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of QDOLO (Tramadol Hydrochloride)

Introduction to QDOLO

QDOLO is an opioid agonist, specifically a formulation of tramadol hydrochloride, indicated for the management of pain severe enough to require an opioid analgesic in adults. It is available as a 5mg/1mL oral solution, designed for precision dosing and individualized pain management[5].

Market Size and Forecast

The global tramadol hydrochloride market, which includes QDOLO, is experiencing significant growth. As of 2022, the global tramadol drug market was valued at USD 5.26 billion and is projected to reach USD 7.29 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.41% from 2023 to 2030[1].

Another estimate suggests that the global tramadol market size was USD 3.462 billion in 2022 and is expected to grow to USD 7.190 billion by 2032, exhibiting a CAGR of 6.87% during this period[3].

Driving Factors

Several key factors are driving the growth of the tramadol hydrochloride market, including:

Increasing Chronic Pain Prevalence

The rising prevalence of chronic pain conditions such as osteoarthritis, post-operative pain, dental pain, neuropathic pain, and cancer is significantly increasing the demand for effective pain management drugs like QDOLO[4].

Aging Population

An aging population contributes to the growth, as older adults are more likely to experience chronic pain and require pain management solutions[1].

Innovations in Drug Delivery

Continuous innovation in drug delivery systems, including the development of oral solutions like QDOLO, is enhancing patient compliance and efficacy, thus driving market growth[1].

Regulatory Environment

FDA Approval and Regulatory Hurdles

The FDA approval process for tramadol hydrochloride formulations, including QDOLO, has faced regulatory hurdles. For instance, the IV formulation of tramadol hydrochloride has encountered disputes and denials of approval due to concerns about delayed onset of analgesia and potential safety risks[1].

Global Regulations

Different regions have varying regulations regarding the use of tramadol. While tramadol IV is already in use in some countries outside the U.S., there is a need for consistent global regulatory standards[1].

Financial Projections

Market Growth

The financial trajectory of the tramadol hydrochloride market, including QDOLO, is promising. The market is expected to grow from USD 5.26 billion in 2022 to USD 7.29 billion by 2030, and another estimate suggests it will reach USD 7.190 billion by 2032[1][3].

CAGR

The CAGR for the market is estimated to be around 4.41% to 6.87% over the forecast periods, indicating steady and robust growth[1][3].

Investment and Innovation

Research and Development

Major pharmaceutical companies are investing heavily in the development and marketing of tramadol hydrochloride formulations. The development of new delivery methods, such as oral solutions and IV formulations, is expected to stimulate further investment and market expansion[1][4].

Market Expansion

Companies are expanding their product lines and entering new markets, particularly in developing countries where there is a growing demand for pain management drugs. This expansion is driven by the increasing prevalence of chronic diseases and the need for effective pain management solutions[1][4].

Public Health Impact

Pain Management

QDOLO and other tramadol hydrochloride formulations fill a critical gap in pain management, providing an alternative to more potent opioids for moderate to moderately severe pain. This is particularly important in reducing the reliance on Schedule II opioids and mitigating the opioid abuse crisis[1].

Abuse Potential

As a Schedule IV drug, tramadol has less abuse potential compared to Schedule II opioids, making it a valuable option for pain management while helping to reduce the overall opioid abuse crisis[1].

Dosage Forms and Market Segments

Oral Solution

QDOLO's oral solution formulation offers precision dosing and individualized pain management, which is a significant advantage in the market. The ease of administration and the flexibility of dosing contribute to its popularity among patients and healthcare providers[5].

Dominance of Tablets

While QDOLO is an oral solution, the tablets segment dominates the global tramadol market due to factors such as ease of manufacturing, convenience of dosing and administration, and cost-effectiveness. However, the oral solution segment is gaining traction due to its unique benefits[4].

Key Players and Competitive Landscape

Established Brands

Companies like Grünenthal, Zydus Group, and GSK plc hold significant positions in the global tramadol market due to their established brand presence and strong strategic partnerships. Other key players include Mundipharma International, Vertical Pharmaceuticals, LLC, Janssen Global Services, LLC, and Cipher Pharmaceuticals Inc.[4].

Strategic Initiatives

These companies are focusing on research and development activities, seeking approvals from regulatory bodies, and launching innovative products to boost their market presence. Such initiatives are expected to sustain their market position and drive further growth[4].

Impact of COVID-19

Market Rebound

The COVID-19 pandemic had a negative impact on the market growth due to decreased patient visits for pain-related conditions and a reduction in elective and non-elective surgeries. However, the market rebounded to pre-pandemic levels in 2022 and is projected to experience moderate CAGR throughout the forecasted period[4].

Key Takeaways

• The global tramadol hydrochloride market, including QDOLO, is growing significantly due to increasing chronic pain prevalence, an aging population, and innovations in drug delivery.
• Europe and Asia Pacific are key regions driving market growth.
• Regulatory hurdles, particularly around the IV formulation, are being addressed through ongoing regulatory reviews.
• Major pharmaceutical companies are investing in research and development to expand the market.
• QDOLO's oral solution formulation offers unique benefits in terms of precision dosing and individualized pain management.
• Tramadol has a lower abuse potential compared to other opioids, making it a valuable option for pain management.

Frequently Asked Questions

1. What is the projected market size of the tramadol hydrochloride market by 2030?

The global tramadol drug market is projected to reach USD 7.29 billion by 2030[1].

2. What are the primary factors driving the growth of the tramadol hydrochloride market?

The primary factors include increasing chronic pain prevalence, an aging population, and innovations in drug delivery[1].

3. How does QDOLO differ from other tramadol formulations?

QDOLO is an oral solution formulation designed for precision dosing and individualized pain management, offering flexibility and ease of administration[5].

4. What is the regulatory status of tramadol hydrochloride in different regions?

Different regions have varying regulations regarding the use of tramadol, with some countries outside the U.S. already using tramadol IV, highlighting the need for consistent global regulatory standards[1].

5. How has the COVID-19 pandemic impacted the tramadol market?

The pandemic had a negative impact on market growth due to reduced patient visits and surgeries, but the market has rebounded to pre-pandemic levels and is expected to grow moderately[4].

References

1. DrugPatentWatch, TRAMADOL HYDROCHLORIDE - Generic Drug Details.
2. FDA, FY 2020 PDUFA Performance Report.
3. PubMed, The economics of follow-on drug research and development.
4. Fortune Business Insights, Tramadol Market Size, Share, Forecast | Growth Report [2032].
5. QDOLO, Patient Site.