INDERIDE LA 160/50 Drug Patent Profile

When do Inderide La 160/50 patents expire, and what generic alternatives are available?

Inderide La 160/50 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in INDERIDE LA 160/50 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 160/50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
DailyMed Link:	INDERIDE LA 160/50 at DailyMed

US Patents and Regulatory Information for INDERIDE LA 160/50

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 160/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-003	Jul 3, 1985		DISCN	No	No

Expired US Patents for INDERIDE LA 160/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERIDE LA 160/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-003	Jul 3, 1985

International Patents for INDERIDE LA 160/50

See the table below for patents covering INDERIDE LA 160/50 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
Ireland	45578	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for INDERIDE LA 160/50

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
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015

Market Dynamics and Financial Trajectory for INDERIDE LA 160/50

Last updated: July 31, 2025

Introduction

INDERIDE LA 160/50, a long-acting formulation of butalbital, acetaminophen, and caffeine, addresses chronic tension headaches and migraines. As a Schedule III barbiturate combination, its market trajectory hinges on regulatory, clinical, and competitive factors. This analysis delves into the market dynamics shaping INDERIDE LA 160/50’s prospects and projects its financial trajectory amid evolving healthcare landscapes.

Regulatory Framework and Approval Landscape

The regulatory environment significantly influences INDERIDE LA’s market penetration. The U.S. Food and Drug Administration (FDA) classifies butalbital-containing products within controlled substances schedules due to potential abuse and dependency risks. INDERIDE LA, a long-acting formulation, faces heightened scrutiny because extended-release barbiturates historically encountered regulatory hurdles stemming from safety concerns and abuse potential (FDA, 2012).

Recent regulatory trends emphasize strict prescription monitoring programs and abuse-deterrent formulations, which could constrain market expansion for INDERIDE LA. However, its unique sustained-release profile presents an opportunity if supported by risk mitigation strategies and robust clinical data demonstrating safety and efficacy.

Clinical and Therapeutic Dynamics

The therapeutic niche for INDERIDE LA 160/50 remains centered on managing debilitating tension headaches and migraines refractory to other medications. Its combination therapy offers rapid relief with sustained effects, potentially reducing dosing frequency and improving patient compliance.

Nevertheless, the evolving landscape favors non-opioid, non-barbiturate therapies—such as CGRP inhibitors and Botox—that have gained FDA approval and market acceptance (Loder et al., 2020). These alternatives often boast better safety profiles, rendering INDERIDE LA less attractive unless it demonstrates superior efficacy or distinct advantages in specific patient subpopulations.

Competitive Landscape

The competitive environment features generic formulations and newer, targeted therapies. In the analgesic domain, recent patent expirations have increased the availability of low-cost generics, pressuring branded drugs like INDERIDE LA to justify premium pricing.

New agents addressing migraine and tension-type headaches, such as ubrogepant and rimegepant, deliver targeted, opioid-sparing options, eroding INDERIDE LA’s market share. The lack of recent patent protections further diminishes exclusivity prospects, challenging sustained profitability.

Market Demand and Epidemiological Trends

Chronic migraines and tension headaches afflict approximately 12% of the global population, with a higher prevalence in women (Stovner et al., 2018). The increasing burden of headache disorders enhances potential demand, particularly if INDERIDE LA can position itself as a reliable, long-acting option.

However, the opioid and barbiturate crisis has led to stricter prescribing guidelines, reducing outpatient prescriptions for barbiturate-containing drugs. This regulatory shift constrains demand growth unless INDERIDE LA is repositioned with tailored risk management.

Pricing and Reimbursement Factors

Pricing strategies are critical, especially amidst aggressive generic competition and cost containment efforts by payers. INDERIDE LA’s premium formulation must justify its value through demonstrable clinical benefits to secure favorable reimbursement.

Insurance coverage and formulary inclusion hinge on cost-effectiveness analyses and clinician acceptance. Potential formulary restrictions on controlled substances could limit access, particularly in managed care settings.

Supply Chain and Distribution Considerations

Manufacturing quality, supply chain stability, and distribution channels influence market availability. As a controlled substance, strict distribution protocols must be maintained to prevent diversion, potentially complicating logistics and increasing costs.

Any disruptions in manufacturing, such as raw material shortages or regulatory compliance issues, could adversely affect supply stability, impacting revenue generation.

Financial Trajectory Projections

Short-term Outlook (1–3 years)

Given current constraints, INDERIDE LA’s sales are expected to remain modest unless new indications or formulations are pursued. Anticipated challenges include regulatory tightening, reimbursement hurdles, and competitive pressure from emerging therapies.

Revenue may stabilize through existing prescriptions in niche patient groups, with modest growth contingent on targeted marketing to specialist physicians and pain management clinics.

Medium to Long-term Outlook (3–10 years)

Long-term growth hinges on strategic repositioning. Potential avenues include pursuing orphan drug status for specific migraine subsets or developing abuse-deterrent formulations aligned with regulatory priorities.

Introducing innovative delivery mechanisms or combination therapies could restore competitive edge. However, patent expirations and market preferences toward novel agents cast uncertainty on sustained profitability.

Revenue Estimates

Assuming moderate market penetration and an average wholesale price (AWP) of approximately $150 per unit, revenue potential remains constrained by volume ceilings, with annual revenues projected in the low hundreds of millions of dollars globally unless significant market expansion materializes.

Strategic Considerations

• Regulatory Engagement: Proactive compliance and demonstration of safety profile are essential to mitigate potential bans or restrictions.
• Clinical Differentiation: Positioning INDERIDE LA as a viable option in patients unsuitable for newer therapies may carve niche demand.
• Partnerships: Collaborations with healthcare providers and payers could facilitate formulary inclusion and enhance prescribing patterns.
• Research and Development: Investment in abuse-deterrent technologies or novel formulations may sustain competitiveness.

Key Takeaways

• Regulatory climate poses significant hurdles for INDERIDE LA 160/50, with increased oversight of controlled substances affecting prescribing and market access.

• Market evolution favors newer, targeted migraine therapies, diminishing the prospective growth of barbiturate-based formulations unless repositioned with added safety features.

• Generic competition and pricing pressures limit revenue potential, underscoring the need for strategic differentiation.

• Demand from the headache patient population is substantial but constrained by changing prescribing behaviors and regulatory controls around controlled substances.

• Innovation and strategic repositioning are essential for future financial sustainability, particularly in adopting abuse-deterrent formulations or exploring new indications.

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FAQs

1. What are the primary market challenges facing INDERIDE LA 160/50?
The main challenges include strict regulatory oversight due to abuse potential, competition from newer migraine therapies, declining prescriptions amidst opioid restrictions, and generic market pressures impacting pricing and profitability.

2. Can INDERIDE LA's long-acting formulation provide a therapeutic advantage?
Potentially, yes. It offers sustained relief, reducing dosing frequency, which might be advantageous for specific patient subsets. However, safety concerns and regulatory scrutiny temper its widespread adoption.

3. What future strategies could enhance INDERIDE LA’s market viability?
Developing abuse-deterrent versions, gaining regulatory approvals for new indications, improving formulations, and establishing strong payer partnerships could bolster its position.

4. How does the increasing prevalence of headache disorders influence INDERIDE LA’s prospects?
While the prevalence suggests a sizable potential market, prescribing practices driven by safety concerns, regulatory shifts, and competition may limit actual utilization.

5. Will patent exclusivity impact INDERIDE LA’s revenue in the coming years?
Given the absence of recent patents and the availability of generics, exclusivity is unlikely, leading to substantial price competition and limited revenue streams unless differentiation strategies are implemented.

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References

[1] FDA. (2012). Guidance for Industry — Abuse-Deterrent Opioids — Evaluation and Labeling. U.S. Food and Drug Administration.
[2] Loder, S., Burch, R., & Rizzoli, P. (2020). The evolving landscape of migraine pharmacotherapy. Neurology Today.
[3] Stovner, L. J., et al. (2018). The global burden of headache: Transnational research. The Journal of Headache and Pain.