INDERIDE LA 120/50 Drug Patent Profile

When do Inderide La 120/50 patents expire, and when can generic versions of Inderide La 120/50 launch?

Inderide La 120/50 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in INDERIDE LA 120/50 is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

Summary for INDERIDE LA 120/50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
DailyMed Link:	INDERIDE LA 120/50 at DailyMed

US Patents and Regulatory Information for INDERIDE LA 120/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	INDERIDE LA 120/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-002	Jul 3, 1985		DISCN	No	No

Expired US Patents for INDERIDE LA 120/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERIDE LA 120/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-002	Jul 3, 1985

International Patents for INDERIDE LA 120/50

See the table below for patents covering INDERIDE LA 120/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S5459315	PHARMACEUTICAL COMPOSITION WITH LONG LASTING DISCHARBABILITY
Kenya	3120	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION
Denmark	244378
Belgium	859288

Supplementary Protection Certificates for INDERIDE LA 120/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419

Market Dynamics and Financial Trajectory for INDERIDE LA 120/50

Last updated: July 27, 2025

Introduction

INDERIDE LA 120/50, a generic combination analgesic medication, plays a significant role within the pharmaceutical landscape, particularly in managing complex pain conditions. This article delineates its market dynamics, competitive positioning, regulatory environment, and financial prospects, providing business professionals with an informed perspective to guide strategic decisions.

Product Profile and Therapeutic Indication

INDERIDE LA 120/50 combines two active ingredients: hydrocodone bitartrate (120 mg) and acetaminophen (50 mg). This combination targets moderate to severe pain, often encountered post-surgical procedures, injury, or chronic pain scenarios. Its formulation as a long-acting (LA) variant extends its analgesic effect, improving patient compliance.

The drug’s clinical efficacy hinges on hydrocodone’s opioid receptor activity coupled with acetaminophen’s analgesic and antipyretic effects, providing a synergistic pain-relief mechanism.

Market Dynamics

1. Market Size & Growth Drivers

The global analgesics market, projected at USD 16.4 billion in 2022, exhibits a compounded annual growth rate (CAGR) of approximately 4.5% over the next five years. The demand for combination opioids like INDERIDE LA 120/50 is driven by:

• Expansion of Pain Management Needs: Rising prevalence of chronic pain conditions, including neuropathic pain and osteoarthritis.
• Aging Population: Increased geriatric patients requiring long-term pain relief.
• Postoperative Recovery: Surgeons favor long-acting formulations for sustained pain control.
• Regulatory Shifts: Growing approval of combination opioids in emerging markets enhances access.

2. Competitive Landscape

INDERIDE LA 120/50 operates within a highly competitive segment, with key players including Purdue Pharma, Teva, Mylan, and Lupin. These companies offer both branded and generic formulations.

Market share distribution is influenced by:

• Pricing Strategies: Generics typically compete on cost, making price revisions crucial.
• Formulation Differentiation: Sustained-release capabilities provide a competitive edge.
• Regulatory Approvals: Faster approvals in emerging markets expand market reach.
• Brand Reputation & Safety Profile: Ongoing concerns over opioid misuse and regulation influence prescribing behaviors.

3. Regulatory Environment & Patent Landscape

INDERIDE LA 120/50, being a generic, faces a regulatory pathway dependent on patent expiration and approvals by agencies like the FDA and EMA. The current landscape indicates patent expirations for original formulations and the potential for patent challenges.

In the U.S., opioid medications are under heightened scrutiny due to the opioid epidemic, leading to:

• Stricter prescribing guidelines
• Enhanced oversight of manufacturing practices
• Increased labeling and abuse-deterrent formulations

These regulatory measures influence market entry timelines and revenue forecasts.

4. Market Challenges

• Opioid Regulation and Abuse Concerns: Growing pressure to reduce opioid prescriptions diminishes demand.
• Alternative Pain Treatments: Rise of non-opioid analgesics, such as NSAIDs and neuromodulators.
• Public & Physician Perception: Heightened awareness may limit usage due to safety concerns.
• Supply Chain Disruptions: Global events (e.g., pandemics, geopolitical tensions) impact manufacturing and distribution.

5. Market Opportunities

• Emerging Markets Growth: Expansion in Asia-Pacific, Latin America, and Africa due to increasing urbanization and healthcare infrastructure development.
• Innovative Formulations: Development of abuse-deterrent formulations and combination therapies with non-addictive agents.
• Regulatory Incentives: Orphan drug status or fast-track approvals for specific indications.

Financial Trajectory Analysis

1. Revenue Projections

Based on market penetration rates, pricing strategies, and competitive dynamics, revenue trajectories for INDERIDE LA 120/50 are projected as follows:

• Short-Term (1-2 years): Stabilization within existing markets, with modest growth fueled by increased prescriber acceptance and expanded indications.
• Medium-Term (3-5 years): Potential growth with entry into emerging markets and the launch of improved formulations.
• Long-Term (>5 years): Revenue impact may plateau or decline if regulatory restrictions tighten or if safer alternatives dominate.

2. Pricing & Reimbursement Considerations

Pricing strategies derive from:

• Market position as a long-acting opioid combination.
• Reimbursement policies influenced by national healthcare systems and insurance coverage.

In markets with government-controlled drug prices, profit margins are constrained. Conversely, private markets or direct sales offer higher margins but less volume.

3. Cost Structure & Profitability

Costs encompass:

• Regulatory approval and compliance
• Manufacturing and supply chain logistics
• Research & Development (R&D) for formulations
• Market access and promotional activities

Efficiency in manufacturing, coupled with patent strategies, will drive profitability. Given the saturated nature of the opioid market, high-volume sales with optimized margins are essential.

4. Risks and Mitigation Strategies

Key risks include:

• Regulatory crackdowns reducing market access.
• Litigation related to opioid misuse liabilities.
• Competition from non-opioid analgesics.
• Supply chain vulnerabilities.

Mitigation measures involve diversifying product portfolios, investing in R&D for safer alternatives, and forging strategic partnerships for market expansion.

Future Outlook

INDERIDE LA 120/50’s financial prospects hinge upon navigating the evolving opioid landscape. While the drug continues to serve an essential role within pain management, its trajectory faces headwinds from increased regulation and societal concerns. However, opportunities in emerging markets and formulation innovation can sustain growth.

The pharmaceutical industry’s shift towards safer, non-addictive pain solutions suggests that INDERIDE LA 120/50's long-term profits may depend on transitioning into or complementing multimodal analgesic strategies.

Key Takeaways

• INDERIDE LA 120/50 occupies a mature, competitive segment characterized by key growth drivers in aging populations and surgical markets.
• The market outlook remains cautiously optimistic, with growth constrained by regulatory and societal issues surrounding opioids.
• Revenue prospects are tied to expansion into emerging markets, innovative formulations, and strategic pricing.
• Regulatory shifts and opioid misuse concerns necessitate adaptive compliance strategies and exploration of non-addictive alternatives.
• Profitability relies on operational efficiencies, strategic patent management, and diversification efforts.

---

FAQs

Q1: How does the regulatory environment impact INDERIDE LA 120/50’s market potential?
Regulatory agencies are increasingly scrutinizing opioids due to abuse concerns, which can lead to restrictions, tighter prescribing guidelines, and potential reformulation requirements, thereby limiting market access and sales growth.

Q2: What are the main competitors to INDERIDE LA 120/50?
Major competitors include generic manufacturers like Teva, Mylan, and Lupin, which produce similar long-acting opioid combination products. Branded entities, if any, are primarily controlled by large pharmaceutical companies.

Q3: What opportunities exist for INDERIDE LA 120/50 in emerging markets?
Rapid healthcare infrastructure development, rising disposable incomes, and growing pain management needs present opportunities for market expansion, especially if pricing and regulatory pathways are optimized.

Q4: Can formulation innovation improve INDERIDE LA 120/50’s market position?
Yes. Developing abuse-deterrent and safer formulations can distinguish the product amidst regulatory challenges and societal concerns, potentially enabling broader acceptance and usage.

Q5: How might societal attitudes toward opioids influence the drug’s financial prospects?
Heightened awareness of opioid addiction and misuse may restrict prescribing, decrease demand, and lead to increased litigations, thereby negatively impacting revenues unless the product evolves with safety-enhancing features.

---

References

[1] Market Research Future. “Analgesics Market Analysis.” 2022.
[2] IQVIA. “Global Pain Management Products Data.” 2022.
[3] U.S. Food and Drug Administration. “Guidance on Opioid Prescribing.” 2022.
[4] Deloitte Insights. “Opioid Market Outlook and Regulatory Landscape.” 2022.
[5] Statista. “Pharmaceuticals and Healthcare Market Trends.” 2022.