PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Drug Patent Profile
When do Propranolol Hydrochloride And Hydrochlorothiazide patents expire, and what generic alternatives are available?
Propranolol Hydrochloride And Hydrochlorothiazide is a drug marketed by Actavis Elizabeth, Ani Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Rising, Warner Chilcott, and Watson Labs. and is included in fifteen NDAs.
The generic ingredient in PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; propranolol hydrochloride. There is one drug master file entry for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.
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Summary for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 15 |
| Clinical Trials: | 1 |
| DailyMed Link: | PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE at DailyMed |
Recent Clinical Trials for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | |
| US Department of Veterans Affairs |
See all PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE clinical trials
US Patents and Regulatory Information for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Propranolol Hydrochloride and Hydrochlorothiazide Market Dynamics, Patent Status, and Financial Outlook
Propranolol hydrochloride and hydrochlorothiazide is a mature fixed-dose antihypertensive combination with limited commercial growth potential. The original branded product, Inderide, has lost market exclusivity, and the combination is generally supplied as a low-cost generic tablet. No meaningful biosimilar risk exists because the product is a small-molecule drug, not a biologic. Financial exposure is concentrated in manufacturing efficiency, generic pricing, pharmacy-channel access, and continued clinical use rather than patent protection.
What is propranolol hydrochloride and hydrochlorothiazide used for?
Propranolol hydrochloride and hydrochlorothiazide combines a nonselective beta-adrenergic blocker with a thiazide diuretic.
| Component | Pharmacologic role | Primary commercial relevance |
|---|---|---|
| Propranolol hydrochloride | Reduces heart rate, myocardial contractility, and renin release | Hypertension, angina, arrhythmias, migraine prevention, tremor, and other off-label uses |
| Hydrochlorothiazide | Promotes sodium and water excretion | Blood-pressure reduction and volume control |
| Fixed-dose combination | Combines complementary antihypertensive mechanisms | Convenience for selected patients requiring both agents |
The product was marketed historically under the Inderide name. Current prescribing information identifies the combination for hypertension in patients who require both propranolol and hydrochlorothiazide, or as a substitution for separately titrated components.[1]
Clinical use has declined relative to newer antihypertensive combinations. Current hypertension treatment guidelines generally prioritize thiazide-type diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, depending on patient characteristics and comorbidities.[2] Beta blockers remain important when there is a separate cardiac indication, but they are not usually the default first-line treatment for uncomplicated hypertension.
What is the FDA regulatory status of propranolol hydrochloride and hydrochlorothiazide?
The product is an approved prescription oral tablet combination. The branded product has no current commercial exclusivity that would prevent abbreviated new drug application, or ANDA, competition.
The regulatory profile is typical of an old small-molecule combination:
| Regulatory issue | Current assessment |
|---|---|
| FDA pathway | Original full NDA approval followed by generic ANDA competition |
| Dosage form | Immediate-release oral tablets |
| Reference product | Historical Inderide product |
| Prescription status | Prescription-only |
| Biologic classification | Not applicable |
| Biosimilar pathway | Not applicable |
| Current exclusivity | No material FDA exclusivity expected |
| Generic pathway | ANDA approval based on pharmaceutical equivalence and bioequivalence |
| Primary regulatory risk | Manufacturing compliance, supply continuity, labeling, and quality controls |
The FDA’s Orange Book identifies therapeutic-equivalence information for approved prescription products, while Drugs@FDA and DailyMed provide historical labeling and regulatory records.[3,4] The product’s age means that commercial competition is primarily governed by generic approval and manufacturing economics rather than regulatory exclusivity.
When does propranolol hydrochloride and hydrochlorothiazide lose exclusivity?
The combination lost practical exclusivity decades ago. Propranolol was approved in the 1960s, and hydrochlorothiazide has an even longer regulatory history. Any original composition, formulation, or use patents associated with the historical branded product would have expired long before the current generic market.
| Exclusivity category | Expected status |
|---|---|
| New chemical entity exclusivity | Expired |
| Original drug patent protection | Expired |
| Pediatric exclusivity | Not commercially relevant |
| Orphan-drug exclusivity | Not applicable |
| New formulation exclusivity | No material current exclusivity identified |
| New clinical-investigation exclusivity | No material current exclusivity identified |
| Current patent barrier | None expected for the standard immediate-release combination |
The relevant commercial question is therefore not when exclusivity ends. It is whether any manufacturer can sustain profitable supply in a low-price, multi-source market.
What patents protect propranolol hydrochloride and hydrochlorothiazide?
No active patent estate is expected to protect the conventional propranolol hydrochloride/hydrochlorothiazide immediate-release tablet as a commercial product.
Potential historical patent categories included:
- The propranolol active ingredient.
- The combination of propranolol with a thiazide diuretic.
- Tablet composition and manufacturing methods.
- Hypertension treatment methods.
- Brand-specific labeling and packaging.
These categories have limited present-day value because the underlying active ingredients are old, the combination has been marketed for many years, and standard tablet technology is widely available. Any residual patent risk would need to arise from a newly developed formulation, delivery system, or manufacturing process rather than from the conventional combination.
Are there formulation patents for the combination?
No commercially significant formulation patent barrier is expected for ordinary immediate-release tablets. The product does not depend on a complex delivery system, controlled-release matrix, depot technology, device, or biologic manufacturing process.
A manufacturer could still obtain patents on a new formulation, such as:
- Modified-release propranolol delivery.
- A novel fixed-dose ratio.
- Taste-masked or orally disintegrating tablets.
- A particular excipient system.
- A manufacturing process that improves stability or dissolution.
Those patents would protect only the claimed innovation. They would not ordinarily block generic manufacturers from selling conventional immediate-release tablets outside the patent claims.
What is the Orange Book status of propranolol hydrochloride and hydrochlorothiazide?
The Orange Book is relevant for identifying approved reference products, generic equivalents, and any listed patents or exclusivity. The standard combination does not appear to have a current patent-based Orange Book position that supports a meaningful barrier to generic entry.[3]
The commercial status is best characterized as follows:
| Orange Book issue | Assessment |
|---|---|
| Reference-listed drug | Historical combination product |
| Listed patent leverage | None expected to be commercially material |
| Paragraph IV exposure | Low strategic significance because the core patents are expired |
| Therapeutic-equivalence relevance | High for approved generic tablets |
| Market access | Primarily determined by ANDA approval and supply economics |
Orange Book status should be distinguished from product availability. An approved generic may remain commercially inactive because of low margins, manufacturing constraints, discontinued marketing, or limited wholesaler demand.
Which companies are challenging the branded product?
The market is no longer defined by a small number of branded challengers. It is a mature generic market in which multiple manufacturers may hold approvals or have held approvals over time.
Generic participation can change frequently because manufacturers discontinue low-volume products, transfer ANDAs, or retain regulatory approval without maintaining substantial commercial inventory. Public data do not reliably establish a single permanent manufacturer set for every strength and package configuration.
Typical competitive participants in mature oral solids include:
- Large U.S. generic manufacturers.
- Contract manufacturers supplying private-label products.
- Regional generic companies.
- Wholesaler or pharmacy-label suppliers.
- Specialty manufacturers maintaining niche low-volume products.
The main competitive variable is not clinical differentiation. It is landed cost per tablet, manufacturing yield, active pharmaceutical ingredient procurement, inventory reliability, and access to pharmacy and hospital distribution.
What generic entry risks exist for propranolol hydrochloride and hydrochlorothiazide?
Generic entry risk is effectively realized rather than prospective. The product has already moved into the multi-source generic phase.
Generic launch scenarios
| Scenario | Commercial effect |
|---|---|
| Additional ANDA entrant | Further price pressure and lower share per supplier |
| Supplier exit | Temporary shortages and short-term price increases |
| API disruption | Higher costs and possible backorders |
| Retail substitution | Continued replacement of branded product with generic tablets |
| Contract-manufacturing shift | Possible changes in package availability without clinical change |
| Brand revival | Unlikely without differentiated labeling, supply, or reimbursement value |
Because the combination is inexpensive and clinically substitutable with separate propranolol and hydrochlorothiazide tablets, a new entrant would face limited pricing power. A manufacturer could gain volume through a supply disruption or preferred channel contract, but durable premium pricing would be difficult to sustain.
How strong is the patent estate for propranolol hydrochloride and hydrochlorothiazide?
The patent estate is weak from a commercial-protection perspective.
| Patent-strength factor | Assessment |
|---|---|
| Active ingredient age | Very old |
| Combination age | Mature |
| Patent expiry exposure | Historical patents expired |
| Formulation complexity | Low |
| Manufacturing complexity | Low to moderate |
| Regulatory substitution | High |
| Generic competition | Established |
| Litigation leverage | Minimal |
| Lifecycle-management potential | Limited |
The product’s defensibility depends more on operational execution than on intellectual property. A supplier with a reliable source of qualified API, validated manufacturing capacity, and broad distribution can retain business even without patent protection. Conversely, a patent owner without cost or supply advantages has little ability to extract licensing revenue.
What patent litigation affects the product?
No significant current patent litigation is expected to affect the standard propranolol hydrochloride/hydrochlorothiazide tablet market.
Paragraph IV litigation typically arises when an ANDA applicant certifies that a listed patent is invalid, unenforceable, or not infringed. That framework has limited relevance here because the core intellectual property is old and no current patent-based launch block is expected.[5]
The likely legal matters are instead ordinary generic-market issues:
- Product-liability claims.
- Manufacturing-defect allegations.
- FDA warning letters or recalls.
- Contract disputes involving supply.
- Trademark and packaging disputes.
- Antitrust claims involving generic supply or distribution.
These issues can affect individual manufacturers but do not establish a durable barrier around the active combination.
What is the financial trajectory of the product?
Standalone global revenue for propranolol hydrochloride/hydrochlorothiazide is not generally disclosed by manufacturers. The product is usually grouped within broader generic portfolios, making a precise market-size figure unavailable from public company filings.
The financial trajectory is nevertheless clear:
- Original branded revenue declined after generic entry.
- Generic volume became the dominant source of supply.
- Unit prices fell as more suppliers entered.
- Revenue became fragmented across manufacturers.
- Gross-margin performance became dependent on procurement and utilization.
- Long-term revenue is likely flat to declining in nominal terms unless supply shortages temporarily raise prices.
Revenue exposure by business model
| Business model | Revenue outlook | Margin outlook |
|---|---|---|
| Historical branded product | Minimal or discontinued | Not applicable or immaterial |
| Large generic manufacturer | Low per-unit revenue with possible scale benefits | Moderate to low |
| Contract manufacturer | Volume-dependent | Low unless capacity is highly utilized |
| API supplier | Linked to several propranolol or HCTZ products | Sensitive to commodity pricing |
| Distributor or wholesaler | High unit turnover, narrow spread | Low |
| Specialty reformulation company | Potentially higher margin | Requires clinical or commercial differentiation |
The economic ceiling is limited by therapeutic substitution. Physicians can prescribe the components separately, and patients can receive common antihypertensive alternatives. A fixed-dose product therefore must compete against both equivalent combinations and separate tablets.
What factors could improve commercial performance?
A manufacturer could improve economics through:
- Reliable supply during competitor shortages.
- Low-cost API sourcing.
- Consolidated manufacturing of multiple tablet strengths.
- Preferred generic contracts.
- Stable national distribution.
- Private-label or institutional supply agreements.
- Packaging optimization.
- Reduced batch-changeover costs.
- A differentiated formulation with a defensible regulatory position.
A shortage-driven price increase would probably be temporary. The market has limited structural ability to support a sustained premium because the active ingredients and tablet technology are widely available.
What manufacturing and intellectual-property barriers exist?
Manufacturing barriers are manageable but not zero. The product requires controlled blending, tablet compression, content uniformity, dissolution testing, stability testing, and compliance with current good manufacturing practice requirements.
Key operational risks include:
- API quality and supplier qualification.
- Cross-contamination controls for potent beta blockers.
- Content uniformity at low-dose strengths.
- Dissolution performance.
- Packaging stability.
- Batch-release testing.
- FDA inspection findings.
- Concentration of production in a small number of facilities.
These are execution barriers rather than proprietary barriers. A new manufacturer would need FDA-compliant facilities and bioequivalence data, but would not need access to a proprietary delivery platform.
How does the combination compare with competing antihypertensive products?
| Product category | Patent position | Clinical positioning | Commercial outlook |
|---|---|---|---|
| Propranolol/HCTZ | Expired, weak | Selected patients needing beta blocker plus diuretic | Mature niche generic |
| Hydrochlorothiazide alone | Expired | Common diuretic option | Large, low-price generic |
| Propranolol alone | Expired | Cardiac and neurologic uses in addition to hypertension | Broader demand than the combination |
| ACE inhibitor/HCTZ | Generally generic | Common combination therapy | Larger and more guideline-aligned market |
| ARB/HCTZ | Mostly generic, with some differentiated products historically | Widely used combination therapy | Stronger demand in many markets |
| Calcium-channel blocker combinations | Mostly generic | Common hypertension treatment | Competitive and broad |
| Newer branded combinations | May retain formulation or use patents | Differentiated or specialty populations | Higher potential pricing |
The combination is disadvantaged by the declining role of beta blockers as first-line therapy for uncomplicated hypertension. Its most durable demand comes from patients who already require propranolol for a cardiac or neurologic reason and also need diuretic treatment.
What licensing deals affect propranolol hydrochloride and hydrochlorothiazide?
No major current licensing transaction is generally associated with the mature immediate-release combination. Historical brand commercialization arrangements may exist in archival records, but they have little impact on present market value.
The product is unlikely to attract a meaningful royalty-bearing license unless a company introduces:
- A new controlled-release formulation.
- A combination with a differentiated clinical indication.
- A specialty dosage form.
- A proprietary manufacturing process with measurable cost or quality advantages.
- A regional commercialization arrangement tied to a supply contract.
What is the geographic market coverage?
The active ingredients are available in numerous countries, but the exact fixed-dose combination is not uniformly marketed worldwide.
| Region | Market characteristics |
|---|---|
| United States | Generic prescription market with limited brand relevance |
| Europe | Country-specific authorization and reimbursement; combination use varies |
| Canada | Generic availability subject to provincial formularies |
| Emerging markets | Potentially broader use of older fixed-dose combinations, but price-sensitive |
| Institutional markets | Procurement and tender awards can determine volume |
| Private retail markets | Pharmacy substitution and local generic availability are decisive |
Geographic revenue depends on local registration, reimbursement, tender access, and manufacturing economics. U.S. regulatory approval does not automatically establish market access elsewhere.
Key Takeaways
- Propranolol hydrochloride and hydrochlorothiazide is a mature fixed-dose antihypertensive combination.
- The historical Inderide brand has no meaningful current exclusivity advantage.
- Core active-ingredient, combination, and conventional formulation patents are expected to be expired.
- The product is a small-molecule drug, so biosimilar competition does not apply.
- Generic competition is established, and Paragraph IV litigation has limited strategic relevance.
- Standalone product revenue is not generally disclosed and is likely small relative to broader generic portfolios.
- Long-term financial performance is expected to be flat or declining, with temporary upside possible during supply disruptions.
- Manufacturing reliability, API cost, FDA compliance, and distribution access matter more than intellectual property.
- Demand is supported by selected patients needing propranolol plus a diuretic, but the combination competes with separate tablets and newer antihypertensive combinations.
- A commercially meaningful revival would require differentiated formulation, reliable shortage supply, or a new channel strategy.
FAQs
Is propranolol hydrochloride and hydrochlorothiazide still sold?
Yes. The combination may remain available through generic manufacturers, although availability can vary by strength, supplier, wholesaler, and country.
Is Inderide still a protected brand?
No meaningful patent or regulatory exclusivity is expected to protect the historical Inderide product. Any remaining trademark rights would not prevent generic substitution under applicable regulatory rules.
Can a generic company launch the combination without a new clinical trial?
An ANDA applicant generally relies on the reference product’s safety and efficacy findings and must demonstrate pharmaceutical equivalence and bioequivalence. The precise evidence package depends on FDA requirements and the proposed product.
Is propranolol/hydrochlorothiazide a high-revenue generic opportunity?
Usually not. It is more likely to be a low-revenue, low-margin portfolio product unless a supplier captures institutional volume, benefits from a competitor shortage, or has an unusually efficient manufacturing platform.
What is the main commercial risk for this product?
The main risk is supply economics. Low prices, fragmented demand, API disruptions, manufacturing findings, and supplier exits can make the product commercially unattractive even when clinical demand remains stable.
References
- DailyMed. (n.d.). Propranolol hydrochloride and hydrochlorothiazide tablet labeling. U.S. National Library of Medicine.
- Whelton, P. K., Carey, R. M., Aronow, W. S., et al. (2018). 2017 ACC/AHA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults. Hypertension, 71(6), e13-e115.
- U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs.
- U.S. Food and Drug Administration. (n.d.). Patent certification and the Paragraph IV process under the Hatch-Waxman Amendments.
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