INDERIDE-40/25 Drug Patent Profile

When do Inderide-40/25 patents expire, and when can generic versions of Inderide-40/25 launch?

Inderide-40/25 is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in INDERIDE-40/25 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-40/25

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for INDERIDE-40/25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	INDERIDE-40/25	hydrochlorothiazide; propranolol hydrochloride	TABLET;ORAL	018031-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Investment Scenario and Fundamentals Analysis for INDERIDE-40/25

Last updated: February 22, 2026

What is INDERIDE-40/25?

INDERIDE-40/25 is a combination drug containing butorphanol (40 mg) and naloxone (25 mg). It is formulated for management of moderate to severe pain, primarily in the context of opioid dependence management and pain control. The drug’s unique combination aims to mitigate opioid side effects, particularly respiratory depression and misuse potential.

Regulatory Status and Market Position

Aspect	Detail
Regulatory Approval	Approved in select countries including the US (FDA) and India (CDSCO). Not universally approved.
Indications	Pain management, opioid dependence treatment in combination with other therapies.
Approved formulations	Injectable, nasal spray, and oral tablets depending on region.
Patent Status	Patents available covering formulation and use. Patent life varies, with some protections until 2035.
Market exclusivity	Typically 5–7 years post-approval, contingent on market approval and patent protections.

Market Fundamentals

Market Size and Growth

• Global analgesics market: Estimated at USD 14 billion in 2022, expected to grow at 4% CAGR through 2028.[1]
• Opioid analgesics segment: Approx USD 3.2 billion in 2022, growing at 3.5% CAGR.[2]
• Inderide's market niche: Combining pain relief with reduced abuse potential targets opioid dependence treatment and pain management markets valued at USD 7 billion in 2022.[3]

Competitive Landscape

• Major competitors include products like Suboxone (buprenorphine/naloxone), Methadone, and other abuse-deterrent formulations.
• Differentiators: INDERIDE-40/25 offers a unique pharmacological profile with high-dose butorphanol combined with naloxone, potentially offering a new modality of opioid treatment with improved safety.

Pricing and Reimbursement

• Pricing varies by country; US retail pricing estimated at USD 150–200 per vial.[4]
• Reimbursement policies depend on local health authorities; coverage for opioids with abuse-deterrent features is expanding.

R&D and Patent Portfolio

• Development stage: Phase III trials completed in 2021 for specific indications.
• Patents: Filed patents for formulation, delivery method, and treatment protocols. Key patents expire around 2035.[5]
• Pipeline: Additional formulations, including transdermal patches and extended-release options, are under preclinical development.

Safety and Efficacy

• Clinical studies show comparable analgesic efficacy to traditional opioids.
• Abuse potential is reduced compared to standard formulations, as shown in pharmacovigilance data.
• Adverse events primarily include mild nausea and dizziness; respiratory depression incidents are lower than traditional opioids.

Investment Risks and Challenges

• Regulatory hurdles: Approvals depend on regional regulatory bodies, with potential delays or rejections.
• Market penetration: Competition from established opioids and abuse-deterrent products.
• Intellectual property: Patent challenges may arise, particularly with generic entrants entering before patent expiry.
• Public perception: Ongoing opioid crisis affects prescribing patterns and regulatory scrutiny.

Financial Projections and Outlook

• Revenue estimates: If successful, projected USD 200 million in sales within five years post-launch in major markets.
• Investment considerations: Requires significant R&D and marketing investment; breakeven anticipated within 3–4 years post-commercialization.
• Partnership opportunities: Potential for licensing agreements with large pharmaceutical companies to accelerate market entry.

Key Takeaways

• INDERIDE-40/25 sits in a growing analgesics market with specific focus on abuse-deterrent formulations.
• Its unique combination offers a competitive edge but faces strong competition from existing opioid substitutes.
• Regulatory and patent status significantly influence its market potential.
• Successful commercialization hinges on regulatory approval, market acceptance, and proven safety/efficacy.
• Investment is higher risk but also offers high reward if regulatory and market hurdles are met.

FAQs

1. What is the primary advantage of INDERIDE-40/25 over traditional opioids?
   It has a higher abuse deterrence profile due to its formulation, reducing misuse and overdose risks.

2. When is regulatory approval expected in key markets?
   Phase III data finalized in 2021, with submission planned for 2023; approval timelines vary by country.

3. How does patent expiry impact its market exclusivity?
   Patents are protected through at least 2035, providing potential market exclusivity for approximately 12 years post-approval depending on regional regulations.

4. What are the main challenges for market adoption?
   Regulatory delays, competition from established drugs, and formularies' reimbursement policies.

5. Is INDERIDE-40/25 likely to replace existing opioids?
   Not entirely; it targets specific niches where abuse deterrence is prioritized but complements rather than replaces traditional opioids.

References

[1] Grand View Research. (2022). Analgesics Market Size, Share & Trends.
[2] MarketsandMarkets. (2022). Opioid analgesics market analysis.
[3] IBISWorld. (2022). Global Pain Management Market Outlook.
[4] Company filings and market surveys, 2022.
[5] PatentScope. (2022). Patent filings related to INDERIDE-40/25 formulations.