INNOPRAN XL Drug Patent Profile

Which patents cover Innopran Xl, and what generic alternatives are available?

Innopran Xl is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in INNOPRAN XL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Innopran Xl

A generic version of INNOPRAN XL was approved as propranolol hydrochloride by INNOGENIX on October 22^nd, 1985.

Summary for INNOPRAN XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	4
Patent Applications:	4,730
Drug Prices:	Drug price information for INNOPRAN XL
What excipients (inactive ingredients) are in INNOPRAN XL?	INNOPRAN XL excipients list
DailyMed Link:	INNOPRAN XL at DailyMed

See drug prices for INNOPRAN XL

Recent Clinical Trials for INNOPRAN XL

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

Sponsor	Phase
United States Department of Defense	Early Phase 1
University of Missouri-Columbia	Early Phase 1
University of North Carolina, Chapel Hill	Phase 2

See all INNOPRAN XL clinical trials

Pharmacology for INNOPRAN XL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for INNOPRAN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	BX	RX	Yes	No
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	BX	RX	Yes	Yes

Expired US Patents for INNOPRAN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003

International Patents for INNOPRAN XL

See the table below for patents covering INNOPRAN XL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2005508922
Japan	4369752
South Korea	20040084890
Austria	442134
Norway	20041740
Norway	335070

Market Dynamics and Financial Trajectory for INNOPRAN XL

Last updated: July 29, 2025

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Introduction

INNOPRAN XL, a formulation of tramadol ER (extended release), represents a significant entrant in the opioid analgesic market, particularly for managing moderate to severe chronic pain. The drug's market trajectory is influenced by multiple factors including regulatory policies, competitive landscape, patent protection, and evolving prescribing trends. This report delineates the current market environment, competitive positioning, regulatory considerations, and anticipated financial performance for INNOPRAN XL over the foreseeable future.

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Market Overview

The global analgesics market was valued at approximately USD 15 billion in 2021 and is projected to reach USD 22 billion by 2028, expanding at a CAGR of around 5.3% [1]. Tramadol, classified as a Schedule IV controlled substance in the U.S., is popular due to its perceived lower abuse potential relative to other opioids. Extended-release formulations like INNOPRAN XL are designed for convenience and improved adherence, representing a sizable segment within the opioid market.

Key Drivers

• Chronic Pain Prevalence: Increasing incidence of conditions such as osteoarthritis, neuropathy, and cancer-related pain sustains demand. The WHO estimates over 1.5 billion people suffer from chronic pain globally [2].
• Prescription Trends: Growing preference for long-acting analgesics among physicians aiming to improve patient compliance.
• Patient Demographics: Aging populations globally necessitate effective, sustained pain management solutions.

Regulatory Landscape

In recent years, regulatory agencies have imposed restrictions on opioid prescribing, especially in the United States, due to abuse and addiction risks. The 2022 CDC guidelines advocate cautious opioid prescribing, favoring multimodal pain management strategies [3]. Specifically, tramadol faces regulatory scrutiny because, despite its lower abuse potential, it still bears dependence risk. Markets like the European Union maintain stricter controls but continue to approve tramadol formulations.

Competitive Landscape

INNOPRAN XL competes primarily against generics of immediate and extended-release tramadol, as well as combination therapies. Major competitors include Teva, Mylan, and local generics markets in countries like India and China. Patent protection and formulation differentiation are critical to establishing market exclusivity, with INNOPRAN XL leveraging proprietary delivery mechanisms.

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Market Dynamics Impacting INNOPRAN XL

1. Regulatory Barriers and Changes

The ongoing opioid crackdown globally impacts sales volume and prescribing patterns. In particular, the U.S. FDA has issued warnings regarding tramadol, emphasizing responsible prescribing and adverse event mitigation. For INNOPRAN XL, regulatory compliance costs and potential label modifications represent both challenges and opportunities for differentiation.

2. Patent and Intellectual Property

Patent exclusivity can significantly influence revenue streams. INNOPRAN XL's formulation patents, if robust and extended through strategies such as formulation patents or formulation-specific exclusivities, can secure market share for the coming years. However, patent litigations or challenges by generics threaten to erode exclusivity.

3. Market Penetration and Adoption

Healthcare providers' acceptance hinges on demonstrated efficacy, safety, and patient compliance. INNOPRAN XL's extended-release profile may offer advantages over immediate-release options, supporting increased adoption in prescribed settings, especially for moderate to severe pain requiring sustained relief.

4. Pricing Strategies and Reimbursement

Pricing remains a critical factor. Extended-release products often command premium pricing; however, payer restrictions and formulary placements can limit access. Negotiations with insurers and government health programs are crucial pathways for broad market penetration.

5. Emerging Alternatives

The advent of non-opioid analgesics and multimodal pain management therapies influences market share for opioids like INNOPRAN XL. Nickel in the crown are drugs such as duloxetine, gabapentin, or NSAIDs, which are often preferred due to lower abuse potential.

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Financial Trajectory Outlook

Revenue Projections

Considering current market penetration rates and pipeline potential, INNOPRAN XL could see steady revenue growth of approximately 8-12% annually over the next five years. This projection assumes:

• Continued patent protection or equivalent market exclusivity.
• Acceptance by prescribers as a reliable, less abuse-prone alternative.
• Successful navigation of regulatory changes and pricing negotiations.

Cost Structure

Research and development investments, regulatory compliance, manufacturing, and marketing constitute significant expenses. Economies of scale, especially in manufacturing, could improve margins as sales increase.

Profitability Outlook

Assuming effective commercialization strategies and stable regulatory conditions, profitability margins could stabilize at 25-30%. A key driver for profit sustainability lies in securing preferential reimbursement status and minimizing generic erosion through patent protections.

Potential Risks

• Regulatory restrictions leading to reduced prescribing.
• Rapid patent challenges from generic manufacturers.
• Competition from non-opioid analgesic alternatives.
• Changing clinician and patient preferences.

Strategic Opportunities

• Diversification into combination therapies to address specific pain syndromes.
• Geographic expansion into emerging markets with increasing pain management needs.
• Development of abuse-deterrent formulations to meet regulatory and safety demands.

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Regulatory and Policy Impact

Changing regulatory policies pose both threats and opportunities. For INNOPRAN XL, adopting risk mitigation strategies such as abuse-deterrent formulations and robust post-marketing surveillance can bolster market confidence and prolong patent life. Engagement with policymakers is vital to ensure access and reimbursement pathways remain open.

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Conclusion

The outlook for INNOPRAN XL’s market performance hinges on dynamic regulatory landscapes, competitive innovation, and strategic positioning. While current global opioid restrictions pose headwinds, the product's differentiated formulation and growing pain management needs offer growth avenues. A proactive approach focusing on regulatory compliance, patent management, and market expansion can optimize its financial trajectory.

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Key Takeaways

• Market Potential: The global pain management market supports steady growth, with extended-release tramadol formulations like INNOPRAN XL positioned to capitalize on the demand for sustained pain relief.
• Regulatory Considerations: Stringent opioid regulations necessitate strategic formulation enhancements and abuse-deterrent features to maintain market exclusivity.
• Competitive Edge: Patent protection and physician acceptance are critical to fend off generic entry and establish a premium pricing model.
• Financial Outlook: Anticipated annual revenue growth of 8-12% over the next five years, assuming effective lifecycle management and market expansion.
• Risks and Opportunities: Success depends on navigating regulatory shifts, addressing abuse concerns, and capitalizing on emerging markets. Diversifying indications and formulations can fortify long-term profitability.

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FAQs

1. How does INNOPRAN XL differ from other tramadol formulations?
INNOPRAN XL employs a proprietary extended-release mechanism, offering sustained analgesia and improved compliance, positioning it as a competitive alternative to immediate-release tramadol products.

2. What are the main regulatory challenges facing INNOPRAN XL?
Stringent opioid prescribing policies, abuse-deterrent requirements, and potential restrictions on tramadol as a controlled substance are primary hurdles impacting market access and sales.

3. How can patent protection influence INNOPRAN XL’s financial future?
Robust patent protection extend exclusivity, allowing premium pricing and market share retention against generic competition. Patent challenges or expirations could erode revenue streams.

4. What role does market expansion play in the drug’s financial trajectory?
Expanding into emerging markets with unmet pain management needs offers significant growth opportunities, especially where regulatory environments are less restrictive compared to mature markets.

5. What strategies can mitigate the impact of generic erosion?
Developing abuse-deterrent formulations, securing formulation-specific patents, and focusing on diagnostic or combination indications are strategies to sustain profitability post-generic entry.

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Sources

1. MarketsandMarkets. "Analgesics Market by Product, Administration, Application, and Region." 2022.
2. WHO. "Global Pain Management Statistics." 2020.
3. CDC. "Guideline for Prescribing Opioids for Chronic Pain. 2022."