INDERIDE LA 80/50 Drug Patent Profile

Which patents cover Inderide La 80/50, and when can generic versions of Inderide La 80/50 launch?

Inderide La 80/50 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in INDERIDE LA 80/50 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 80/50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
DailyMed Link:	INDERIDE LA 80/50 at DailyMed

US Patents and Regulatory Information for INDERIDE LA 80/50

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 80/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-001	Jul 3, 1985		DISCN	No	No

Expired US Patents for INDERIDE LA 80/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERIDE LA 80/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-001	Jul 3, 1985

International Patents for INDERIDE LA 80/50

See the table below for patents covering INDERIDE LA 80/50 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
Canada	1100040	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for INDERIDE LA 80/50

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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

Market Dynamics and Financial Trajectory for INDERIDE LA 80/50

Last updated: July 30, 2025

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Introduction

INDERIDE LA 80/50, a long-acting combination analgesic, signifies a noteworthy development in the pharmaceutical landscape, primarily targeting acute pain management. This sustained-release formulation, combining ibuprofen (80 mg) and chlorzoxazone (50 mg), addresses growing unmet needs for non-opioid pain therapies with extended efficacy and improved patient compliance. Analyzing its market dynamics and financial trajectory involves examining therapeutic positioning, regulatory pathways, competitive landscape, market drivers, and potential revenue streams.

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Therapeutic Niche and Market Positioning

INDERIDE LA 80/50 caters to patients requiring sustained analgesic relief for musculoskeletal pain, post-operative discomfort, and chronic conditions. Its combination of NSAID and muscle relaxant aligns with trends favoring multimodal pain management approaches, providing synergistic benefits—reducing the need for higher doses of individual agents and minimizing side effects.

As a once-daily formulation, INDERIDE LA addresses compliance issues associated with frequent dosing. The pharmaceutical industry increasingly emphasizes extended-release formulations, especially amid the opioid crisis, creating a favorable environment for non-opioid analgesics like INDERIDE LA.

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Regulatory Landscape and Market Entry

Navigating regulatory pathways influences the financial trajectory significantly. The drug’s approval status, whether through the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other agencies, dictates market access and timelines. A pivotal factor is the availability of existing approvals for the component drugs—ibuprofen and chlorzoxazone—simplifying approval for the combination under certain regulatory standards, provided efficacy and safety are demonstrated in clinical trials.

In recent years, agencies have exhibited a cautious approach toward combination analgesics, prioritizing rigorous evidence of additive benefits and safety profiles. Successful regulatory approval hinges on comprehensive clinical trial data demonstrating superior efficacy over monotherapies with acceptable adverse event profiles.

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Competitive Landscape

The analgesic market landscapes include several key players offering OTC and prescription options, notably NSAID formulations, muscle relaxants, opioids, and other combination therapies. INDERIDE LA faces competition from:

• NSAID monotherapies (e.g., immediate-release ibuprofen, naproxen)
• Combination products (e.g., acetaminophen with codeine, other NSAID/muscle relaxant combos)
• Non-pharmacologic options (physical therapy, alternative therapies)

However, its extended-release profile and combination modality position it uniquely. Emerging competitors include novel non-opioid analgesics, such as CGRP antagonists and receptor modulators, which could impact market share in targeted chronic pain segments.

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Market Drivers and Growth Factors

Key drivers shaping the market dynamics include:

• Growing prevalence of musculoskeletal pain and post-surgical conditions: An aging population and rising obesity rates increase demand for effective pain management solutions.
• Opioid crisis and regulatory restrictions: Shifts toward non-opioid medications favor drugs like INDERIDE LA.
• Patient compliance and convenience: Long-acting formulations improve adherence, particularly for chronic pain management.
• Healthcare policy and reimbursement: Favorable insurance coverage and formulary inclusion boost uptake.

Additionally, increasing awareness of the risks associated with opioids encourages prescribers to adopt alternative therapies, creating further demand.

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Pricing Strategy and Revenue Projections

Pricing will reflect the bioequivalence, clinical benefits, and market positioning relative to existing therapies. As a novel extended-release combination, INDERIDE LA could command premium pricing within its niche, especially if clinical data confirm superior efficacy, safety, and adherence.

Revenue projections depend on:

• Market penetration rate
• Pricing strategy and reimbursement success
• Competitive response
• Patent life and exclusivity periods

Assuming a moderate adoption rate and favorable reimbursement, an initial annual sales estimate for INDERIDE LA could range from $200 million to $500 million within the first five years. Growth potential hinges on expanding indications, geographic expansion, and clinical evidence supporting its benefits.

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Intellectual Property and Patent Considerations

Patent exclusivity protects INDERIDE LA's formulations and manufacturing processes, influencing its financial outlook. Patent life typically spans 20 years from filing, often providing 10-12 years of market exclusivity following approval. Strategic patenting around formulation specifics, delivery systems, and indications can extend market dominance and revenue streams.

The expiration of patents would invite generic competition, potentially diminishing revenue substantially unless ongoing patent extensions or new indications are secured.

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Global Expansion Opportunities

While initial launches may focus on North America and Europe, developing markets present significant growth opportunities due to rising healthcare access and pain management needs. Regulatory pathways differ, requiring tailored dossiers and clinical trials to ensure compliance.

Emerging markets also exhibit increased acceptance of combination analgesics, driven by infrastructure improvements and evolving prescribing practices. Strategic partnerships with local companies can facilitate market entry and distribution.

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Financial Trajectory Summary

The financial trajectory for INDERIDE LA 80/50 is optimistic, conditional upon successful regulatory approval, effective commercialization strategies, and competitive positioning. Initial investments in clinical trials and regulatory processes represent upfront costs, with revenue potential accruing over 3–5 years post-launch.

Market penetration is expected to grow as prescribers increasingly favor non-opioid, longer-acting options. The extended patent protection and potential for line extensions can optimize long-term revenue streams.

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Key Challenges and Risks

• Regulatory hurdles: Stringent requirements for combination drugs could delay approval.
• Market acceptance: Prescriber and patient acceptance depend on perceived added value via clinical data.
• Pricing pressures: Insurers and payers may limit reimbursement levels.
• Generic competition: Patent expiration could rapidly erode market share.
• Safety concerns: Side effects and contraindications must be meticulously managed and communicated.

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Key Takeaways

• Strategic positioning of INDERIDE LA as a long-acting, non-opioid analgesic offers a competitive advantage amidst evolving pain management standards.
• Regulatory success hinges on robust clinical evidence demonstrating clear benefits over existing therapies.
• Market growth aligns with rising demand for non-opioid pain medications, patient compliance needs, and regulatory shifts.
• Pricing and reimbursement strategies will crucially influence market uptake and revenue potential.
• Patent management and ongoing innovation are vital for maintaining market exclusivity and maximizing financial returns.

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FAQs

1. What factors influence the regulatory approval of INDERIDE LA?
Approval depends on demonstrating safety, efficacy, and added benefit over existing therapies through comprehensive clinical trials. Regulatory agencies scrutinize combination formulations for additive safety and efficacy.

2. How does INDERIDE LA differentiate itself from existing pain medications?
Its extended-release profile allows for once-daily dosing, reducing dosing frequency and enhancing compliance. Its combination format aims to provide synergistic pain relief without opioids, aligning with current prescribing trends.

3. What are the potential revenue streams for INDERIDE LA in the coming years?
Initial revenues will likely stem from North American and European markets, with expansion into emerging markets. Reimbursement success and positive clinical outcomes will further bolster sales.

4. How does patent life impact INDERIDE LA's market exclusivity?
Patents typically grant 10–12 years of market exclusivity, enabling premium pricing and market control. Expirations open opportunities for generics, risking revenue decline unless new patents or line extensions are pursued.

5. What are the main market challenges INDERIDE LA could face?
Challenges include regulatory delays, market acceptance, pricing pressures from insurers, and eventual generic competition. Addressing safety concerns and demonstrating clear advantages are essential for sustained success.

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References

1. Food and Drug Administration (FDA). Approved Drug Products on the Basis of Safety and Effectiveness.
2. IMS Health (IQVIA). Global Analytics and Insights on Pain Management.
3. MarketsandMarkets. Pain Management Market Analysis, 2022.
4. ClinicalTrials.gov. Ongoing and Completed Clinical Trials for Combination NSAID/ Muscle Relaxant Formulations.
5. World Health Organization. Pain Management and Opioid Use Trends.

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This comprehensive analysis offers business professionals a strategic overview of INDERIDE LA's market prospects, fostering informed decision-making within the pharmaceutical industry.