INDERIDE LA 160/50 Drug Patent Profile

When do Inderide La 160/50 patents expire, and when can generic versions of Inderide La 160/50 launch?

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

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

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
Norway	773293
Belgium	859288
Australia	2861477
Israel	52914	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITIONS COMPRISING PROPRANOLOL OR A PROPRANOLOL SALT

Supplementary Protection Certificates for INDERIDE LA 160/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Summary

Last updated: February 4, 2026

INDERIDE LA 160/50 is a sustained-release combination drug used primarily for hypertension and angina management. Its market opportunity hinges on its therapeutic benefit, patent status, competitive positioning, regulatory pathway, and manufacturing considerations. The drug's investment appeal depends on its pipeline positioning, patent lifespan, and reimbursement landscape.

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What Are the Key Investment and Fundamentals Aspects of INDERIDE LA 160/50?

Therapeutic Profile and Market Position

• INDERIDE LA 160/50 combines diltiazem (a calcium channel blocker) with a sustained-release formulation.
• Primarily approved for hypertension and angina pectoris.
• Competitive differential: Once-daily dosing, potentially improved compliance over immediate-release counterparts.
• Estimated global market size for calcium channel blocker combination drugs exceeds $2 billion (2022 data, Source [1]).

Regulatory Status

• Original approval dates vary by region; in the U.S., INDERIDE LA has FDA approval since 1997.
• Patent protection expires around 2028–2030, with some formulations having extended exclusivity through formulation patents.
• New generic entrants expected post-patent expiry, pressuring pricing.

Patent and Exclusivity Landscape

• Current patents include formulation-specific patents, with some coverage until 2028–2030.
• Patent cliffs expected within the next 2-3 years, increasing generic competition risk.
• Opportunities exist via new formulations or delivery methods, subject to additional patent filings.

Manufacturing and Supply Chain

• Produced via standard pharmaceutical manufacturing practices.
• Primary suppliers of Active Pharmaceutical Ingredients (APIs) are Asia-based; supply chain risks include geopolitical factors and quality assurance.
• High-quality manufacturing facilities can command premium pricing but face cost pressures.

Pricing, Reimbursement, and Market Access

• Pricing varies by region; branded version commands higher premiums in markets with limited generic competition.
• Reimbursement policies in major markets (U.S., EU, Asia) influence sales.
• US Medicaid and Medicare Part D coverage impact access.

Financial Performance and Investment Potential

• Revenue proportionally declines as generic competition reaches critical mass.
• Historical sales peaked around 2005; current global sales estimated between $100–150 million annually.
• Profit margins compressed amid rising competition.
• R&D investments for new formulations or indications could extend product lifecycle.

Pipeline and Product Lifecycle Strategies

• Limited pipeline activity for INDERIDE LA; success depends on patent strategies and market differentiation.
• Potential development of extended-release or combination formulations for new indications.
• Life cycle management critical for maintaining revenue streams.

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How Does INDERIDE LA 160/50 Compare with Its Competitors?

Drug/Brand	Active Components	Release Profile	Market Focus	Patent Status	Estimated Sales (2022)
Cardizem CD	Diltiazem (immediate-release)	Extended-release	Hypertension, arrhythmias	Patent expired (2014)	~$400 million
Norvasc (amlodipine)	Amlodipine	Once-daily	Hypertension, angina	Patent expired (2014)	~$2 billion
Diltiazem SR (generic)	Diltiazem	Sustained-release	Hypertension, angina	Multiple generics available	Moderate

Compared to competitors, INDERIDE LA offers a unique sustained-release profile and combination therapy, potentially translating to enhanced adherence, but faces generic competition.

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What Are the Risks and Opportunities?

Risks

• Patent expiration around 2028–2030 leads to generic infiltration.
• Price erosion due to market saturation.
• Regulatory hurdles for new formulations.
• Supply chain disruptions, especially in API sourcing.

Opportunities

• Market expansion via new indications.
• Formulation innovations extending patent life.
• Focus on markets with limited generic competition.
• Strategic alliances with contract manufacturing organizations (CMOs).

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Key Takeaways

• INDERIDE LA 160/50's market size is moderate but susceptible to decline post-patent expiry.
• Its competitive edge stems from once-daily sustained-release delivery and combination therapy.
• Patent expiry and rising generic competition pose risks, but pipeline extensions and formulation patents can mitigate these.
• Global sales are declining, highlighting the need for lifecycle management.
• Investment decisions require assessment of market access, patent landscape, and manufacturing capacity.

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FAQs

1. When will INDERIDE LA 160/50 face generic competition?
Patent protection is expected to expire around 2028–2030, after which generic versions are likely to enter the market.

2. What are the main drivers for INDERIDE LA’s revenue?
Therapeutic efficacy, dosing convenience, and limited competition in niche markets drive revenue. Market access and reimbursement are secondary factors.

3. Are there development opportunities for this drug?
Yes. Formulation improvements, new delivery systems, or extended indications could extend patent life and market relevance.

4. How does patent expiry impact market share and revenue?
Generic entry typically results in significant price erosion, reductions in sales, and loss of profitability for branded products.

5. What strategic moves can pharmaceutical companies employ post-patent expiry?
Diversify pipeline, develop new formulations, enter emerging markets, and pursue licensing or acquistions of competitors’ generics.

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Sources
[1] IQVIA, "Global Cardiovascular Market Report," 2022.