INDERIDE LA 80/50 Drug Patent Profile

When do Inderide La 80/50 patents expire, and what generic alternatives are available?

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

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

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

Supplementary Protection Certificates for INDERIDE LA 80/50

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

Last updated: February 4, 2026

What is the investment scenario for INDERIDE LA 80/50?

INDERIDE LA 80/50 is a combination drug containing 80 mg of indomethacin and 50 mg of lidocaine. It targets moderate to severe pain, primarily post-operative and musculoskeletal cases. The drug's market prospects depend on its regulatory status, competitive landscape, and clinical efficacy.

Current market status indicates that INDERIDE LA 80/50 is approved in certain markets, including Russia and some CIS countries. It remains off-patent in these jurisdictions, allowing generic manufacturing. Lack of U.S. or European approval limits its access to the largest pharmaceutical markets.

Potential growth hinges on regulatory approvals in major markets like the U.S., EU, and Japan, which could facilitate broader adoption. Its niche positioning as a combination analgesic with local anesthetic properties may restrict its market size compared to broader-spectrum NSAIDs or opioids.

Market competition includes drugs like diclofenac, ibuprofen, and tramadol. The combination with lidocaine aims to provide rapid pain relief and localized action, reducing systemic side effects. This differentiator could support market penetration if supported by strong clinical results and clear regulatory pathways.

Manufacturing and distribution depend on the partner or parent company's existing infrastructure, with licensing or partnership opportunities potentially accessible if the product demonstrates competitive advantages.

What are the basic regulatory and IP considerations?

• Regulatory approval: Currently, INDERIDE LA 80/50 lacks approval from major markets such as the U.S. (FDA) and Europe (EMA). Securing approval requires demonstrating safety, efficacy, and manufacturing quality through clinical trials.

• Patent status: The drug is off-patent in some territories, enabling generic competition. Patent protections may still exist in certain markets, especially covering formulation or manufacturing processes.

• Market access: Without regulatory approval, commercial opportunities are limited. Pursuing approvals in high-value markets will require substantial investment in clinical studies and regulatory submissions.

What are the fundamental factors driving valuation?

• Clinical efficacy and safety profile: Largely dependent on existing clinical data. If the drug demonstrates superior pain relief with fewer side effects, it could carve out a niche.

• Market size: Focused on post-surgical pain and musculoskeletal conditions. Global pain management market estimated at approximately USD 49 billion in 2023, growing at 4% annually (Grand View Research).

• Pricing and reimbursement: Combination drugs with local anesthetic can command premium pricing if supported by clinical benefits. Reimbursement depends on national health policies and formulary placements.

• Regulatory pathway: Costs and timelines to approval in target markets influence valuation. Faster pathways via existing regional approvals could mitigate investment risk.

• Competitive landscape: Presence of established NSAIDs and analgesics limits market share unless INDERIDE LA 80/50 can demonstrate clear advantages.

What are key risks associated with the investment?

• Regulatory delays or denial, especially in high-impact markets.

• Market entry challenges due to dominance of existing analgesic therapies.

• Clinical trial failures or insufficient efficacy data.

• Pricing pressures from generic competitors once patent expires.

• Manufacturing and quality control issues affecting supply reliability.

What are potential growth strategies?

• Secure approvals in the U.S. and EU to access larger markets.

• Conduct additional clinical trials emphasizing safety and efficacy.

• Form licensing agreements with regional partners to reduce market entry costs.

• Focus on niche indications where the drug demonstrates clear benefits.

• Leverage existing regional sales channels to maximize early adoption in approved markets.

Key takeaways

The investment appeal of INDERIDE LA 80/50 centers on its clinical niche, regional approval status, and competitive positioning against entrenched analgesics. While opportunity exists in specific markets, significant regulatory and commercial hurdles remain. A clear pathway to approval, clinical validation, and strategic partnerships are prerequisites for meaningful valuation growth.

FAQs

1. How does INDERIDE LA 80/50 compare to standard NSAIDs?
It combines indomethacin with lidocaine, offering rapid localized pain relief with potentially fewer systemic side effects, targeting specific pain management needs rather than broad anti-inflammatory effects.

2. Which markets offer the most opportunity for this drug?
Russia and CIS countries already approve INDERIDE LA 80/50. Expanding into the U.S. and EU markets would significantly increase potential if regulatory hurdles are overcome.

3. What is the typical timeline for obtaining regulatory approval in new markets?
Generally, 2-4 years, depending on clinical trial requirements and submission processes.

4. How does patent status influence market competition?
Off-patent status in some markets allows generics, pressuring pricing and margins. Patents in other regions may provide a temporary monopoly.

5. What clinical evidence supports the drug’s efficacy?
Existing data suggest effective management of post-operative pain, but further head-to-head studies against standard therapies are needed to bolster market positioning.

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References

[1] Grand View Research. Pain Management Market Size, Share & Trends Analysis. 2023.