DUTOPROL Drug Patent Profile

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Which patents cover Dutoprol, and when can generic versions of Dutoprol launch?

Dutoprol is a drug marketed by Concordia and is included in one NDA.

The generic ingredient in DUTOPROL is hydrochlorothiazide; metoprolol succinate. There is one drug master file entry for this compound. Additional details are available on the hydrochlorothiazide; metoprolol succinate profile page.

Summary for DUTOPROL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Drug Prices:	Drug price information for DUTOPROL
What excipients (inactive ingredients) are in DUTOPROL?	DUTOPROL excipients list
DailyMed Link:	DUTOPROL at DailyMed

See drug prices for DUTOPROL

US Patents and Regulatory Information for DUTOPROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Concordia	DUTOPROL	hydrochlorothiazide; metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	021956-001	Aug 28, 2006		DISCN	Yes	No
Concordia	DUTOPROL	hydrochlorothiazide; metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	021956-002	Aug 28, 2006		DISCN	Yes	No
Concordia	DUTOPROL	hydrochlorothiazide; metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	021956-003	Aug 28, 2006		DISCN	Yes	No

Dutoprol Market Dynamics and Financial Trajectory

Last updated: September 24, 2026

Dutoprol is a fixed-dose antihypertensive combining metoprolol succinate extended release and hydrochlorothiazide. Its commercial trajectory is that of a mature, low-growth cardiovascular product: initial differentiation through once-daily combination dosing, followed by erosion from generic metoprolol and hydrochlorothiazide products, limited brand visibility, and the absence of publicly reported standalone sales.

No reliable public source reports Dutoprol revenue separately from AstraZeneca’s broader cardiovascular portfolio. The product’s current commercial value is therefore best assessed through prescription substitution, generic availability, market maturity, and the status of its regulatory and patent protection rather than through disclosed brand sales.

What is Dutoprol and how is it used?

Dutoprol is an oral, once-daily fixed-dose combination for hypertension. It contains:

Component	Pharmacologic role
Metoprolol succinate	Extended-release beta-1 selective adrenergic blocker
Hydrochlorothiazide	Thiazide diuretic

The combination lowers blood pressure through complementary mechanisms. Metoprolol reduces cardiac rate and contractility, while hydrochlorothiazide promotes sodium and fluid excretion.

Dutoprol was developed as a combination around metoprolol succinate extended release, the active ingredient used in Toprol-XL. The product was approved by the U.S. Food and Drug Administration in the mid-2000s for hypertension. The FDA label identifies the product as an extended-release tablet intended for once-daily use. [1]

The product’s commercial rationale was convenience. Patients requiring both a beta blocker and a diuretic could receive one tablet instead of two separate prescriptions.

When did Dutoprol lose exclusivity?

Dutoprol’s meaningful market exclusivity has expired. The product belongs to a therapeutic class with long-standing generic competition, and its individual components are widely available at low cost.

The main exclusivity erosion factors were:

• Expiration of the relevant patent protection surrounding the fixed-dose product and its underlying technologies.
• Generic availability for metoprolol formulations.
• Generic availability for hydrochlorothiazide.
• Prescriber preference for titrating the two components separately.
• Payer pressure favoring inexpensive component products.

The commercial distinction between Dutoprol and generic alternatives is limited. A generic combination, where available, can compete directly. Separate metoprolol succinate extended-release and hydrochlorothiazide tablets can also be substituted clinically, although the two-tablet regimen does not provide the same adherence convenience.

What is the FDA regulatory status of Dutoprol?

Dutoprol is an FDA-approved prescription product. Its regulatory status should be distinguished from its commercial status.

Regulatory issue	Assessment
Active ingredient	Metoprolol succinate and hydrochlorothiazide
Dosage form	Extended-release oral tablet
Route	Oral
Therapeutic area	Hypertension
FDA pathway	New Drug Application
Regulatory exclusivity	Expired
Current commercial position	Mature, low-growth product
Safety-related withdrawal	No established evidence of a safety withdrawal as the primary commercial driver

A product may remain listed in FDA databases while having limited distribution or no meaningful branded sales. FDA discontinuation or marketing-status entries do not necessarily mean that the underlying ingredients are unavailable. Metoprolol and hydrochlorothiazide remain widely used antihypertensive therapies through other products.

What patents protect Dutoprol?

The original commercial protection for Dutoprol was linked to the fixed-dose combination, its formulation, and the underlying extended-release metoprolol technology. Those protections no longer create a material barrier to ordinary generic competition.

The remaining intellectual-property questions are narrower:

1. Whether any formulation patent remains listed for a particular generic product.
2. Whether a manufacturer has proprietary manufacturing know-how for extended-release metoprolol.
3. Whether a company has separately protected a new strength, release profile, or combination product.
4. Whether a jurisdiction outside the United States has a live patent with a later expiration date.

The Orange Book is the principal U.S. source for drug patents and exclusivity information. A current product-specific assessment should rely on the latest Orange Book entry and FDA patent-listing records rather than historical patents associated with Toprol-XL or unrelated metoprolol products. [2]

Are there formulation patents for Dutoprol?

The principal technical value in Dutoprol is the extended-release delivery of metoprolol succinate. Hydrochlorothiazide is a long-established generic ingredient. The formulation challenge is therefore concentrated in:

• Controlled release of metoprolol.
• Dose uniformity.
• Stability of the combination tablet.
• Compatibility between the beta blocker and diuretic.
• Bioequivalence against the reference product.

These barriers are meaningful during development but weak after regulatory approval and commercial scale-up. They do not normally support premium pricing once multiple manufacturers have established bioequivalent products.

Are there method-of-use patents for Dutoprol?

The hypertension indication is mature and generally does not create a durable method-of-use barrier. No widely recognized, commercially significant method-of-use patent appears to support a current premium market position for Dutoprol.

How many patents cover Dutoprol today?

The number of historically associated patents is less important than the number of unexpired, enforceable patents that could block an FDA-approved generic. Dutoprol does not appear to have a commercially meaningful active patent estate capable of preserving brand-level exclusivity in the United States.

A practical patent-strength assessment is:

Patent factor	Commercial assessment
Composition-of-matter protection	Not material for the mature ingredients
Original formulation protection	Expired or no longer commercially decisive
Method-of-use protection	Limited
Manufacturing know-how	Potentially relevant but generally nonblocking
Orange Book leverage	Low
Paragraph IV exposure	Historically relevant during generic entry, not a current primary market driver
Litigation leverage	Low relative to protected specialty drugs

Did Dutoprol face Paragraph IV challenges?

Paragraph IV litigation is most relevant when a generic applicant certifies that a listed patent is invalid, unenforceable, or would not be infringed. Mature metoprolol products have historically attracted generic competition and patent disputes, particularly around extended-release formulations and bioequivalence.

For Dutoprol, Paragraph IV risk would have been concentrated around any listed combination or extended-release formulation patents. That risk is now largely historical. The business question is not whether a future Paragraph IV challenge will materially disrupt the brand, but whether any remaining listed patent could delay a specific generic product.

No current, material Dutoprol-specific Paragraph IV dispute is a central driver of the product’s market value based on publicly established information.

What is the Orange Book status of Dutoprol?

The Orange Book remains the relevant U.S. reference for:

• Approved products.
• Reference-listed drug status.
• Patent listings.
• Regulatory exclusivity.
• Generic application certifications.

Dutoprol’s strategic value is constrained because regulatory approval does not equal commercial protection. Even if a reference product remains listed, its pricing power is limited when the active ingredients and therapeutic alternatives are broadly genericized.

The distinction matters for valuation. A listed reference product can retain regulatory significance for abbreviated new drug applications while generating little or no material brand revenue.

How does Dutoprol compare with competing antihypertensive products?

Dutoprol competes with both branded fixed-dose combinations and separate generic components.

Product category	Competitive position versus Dutoprol
Generic metoprolol succinate ER	Lower-cost substitute for the beta-blocker component
Generic hydrochlorothiazide	Lower-cost substitute for the diuretic component
Separate two-drug therapy	Allows independent dose titration
Other beta blocker/thiazide combinations	Compete on price, dosing, and formulary placement
ACE inhibitor/thiazide combinations	Strong alternative for many hypertension patients
ARB/thiazide combinations	Often preferred when tolerability or guideline positioning favors an ARB
Calcium-channel blocker combinations	Compete in first-line hypertension treatment

Dutoprol’s strongest remaining commercial argument is adherence. A fixed-dose tablet can reduce pill burden. Its weakness is reduced dosing flexibility. Physicians may prefer separate products when they need to adjust metoprolol and hydrochlorothiazide independently.

What is Dutoprol’s financial trajectory?

Dutoprol’s financial trajectory can be divided into four stages.

Launch and portfolio positioning

At launch, the product benefited from the clinical familiarity of metoprolol and the convenience of once-daily combination dosing. Commercial support could be linked to AstraZeneca’s broader Toprol-XL franchise and cardiovascular sales infrastructure.

Early adoption

Adoption depended on whether prescribers viewed the combination as more convenient than prescribing two inexpensive agents separately. Fixed-dose combinations often gain traction in patients already stabilized on both ingredients, but they can face resistance when clinicians need flexible titration.

Generic erosion

The principal value loss occurred as generic competition expanded. Once metoprolol succinate extended-release products and hydrochlorothiazide were available at low prices, the brand’s ability to maintain a premium declined.

Typical effects of generic erosion include:

• Lower average selling price.
• Formulary exclusion or unfavorable tier placement.
• Reduced physician-directed brand prescribing.
• Pharmacy substitution.
• Declining promotional investment.
• Shrinking contribution to the originator’s cardiovascular portfolio.

Mature residual demand

Any remaining Dutoprol revenue is likely to come from residual brand prescriptions, institutional purchasing, legacy prescribing habits, and patients who value a specific fixed-dose formulation. This is a maintenance market, not a growth market.

A standalone revenue forecast cannot be supported from public company reporting because AstraZeneca has historically reported products within broader therapeutic and geographic segments rather than disclosing a separate Dutoprol line item. The most defensible financial conclusion is that Dutoprol is immaterial to AstraZeneca’s consolidated revenue compared with major oncology, respiratory, cardiovascular, and specialty-care products.

Which companies are challenging Dutoprol?

Competition is primarily generic and may involve multiple manufacturers depending on market and product availability. Relevant competitor groups include:

• Manufacturers of generic metoprolol succinate extended-release tablets.
• Manufacturers of generic hydrochlorothiazide.
• Manufacturers of other beta blocker/thiazide combinations.
• Manufacturers of ACE inhibitor, ARB, and calcium-channel blocker combinations.
• Mail-order and retail pharmacy suppliers that substitute lower-cost products.

The competitive risk is diffuse. No single rival needs to displace Dutoprol. Price competition from several generic suppliers can reduce brand share and net price simultaneously.

What generic launch risks exist?

Generic entry risk is high in economic terms but low in litigation significance. The major risks are:

1. Direct substitution by a generic fixed-dose product.
2. Substitution by separate generic components.
3. Payer-mandated step therapy.
4. Loss of pharmacy shelf presence.
5. Declining physician awareness.
6. Reduced manufacturing scale and distribution efficiency.

A generic launch would not need to replicate the brand’s historical promotional infrastructure. Regulatory approval, reliable supply, and a low acquisition cost would be sufficient in a mature hypertension market.

What manufacturing and intellectual-property barriers remain?

Manufacturing barriers are moderate at the technical level and low at the commercial level. Extended-release tablets require validated dissolution performance, content uniformity, stability, and bioequivalence. These requirements can delay development, but they do not normally support long-term price protection after several manufacturers have entered.

The most relevant operational risks are:

• Active pharmaceutical ingredient supply.
• Extended-release manufacturing capacity.
• Product recalls caused by dissolution or content-uniformity failures.
• FDA inspection findings.
• Inventory disruptions.
• Contract-manufacturing economics at low prices.

These risks affect supply continuity more than patent exclusivity.

What is the biosimilar risk for Dutoprol?

There is no biosimilar risk. Dutoprol is a small-molecule oral drug, not a biologic. Its competitive threat comes from generic drugs approved through the abbreviated new drug application pathway, not from biosimilars under the Biologics Price Competition and Innovation Act.

What licensing deals affect Dutoprol?

No major current licensing transaction is publicly associated with Dutoprol that would materially change its market outlook. Its commercial history is tied primarily to AstraZeneca’s internal cardiovascular portfolio and the broader metoprolol franchise.

Any later transfer, authorized-generic arrangement, or regional commercialization agreement would need to be evaluated separately by jurisdiction. Such arrangements would not, by themselves, restore meaningful U.S. exclusivity.

What litigation affects Dutoprol?

The commercially important litigation window was the period surrounding patent enforcement and generic entry for metoprolol extended-release products. Current valuation is unlikely to depend on an active Dutoprol litigation campaign.

The absence of material current litigation is consistent with the product’s mature status. Litigation costs are difficult to justify when the addressable branded revenue pool is small and the relevant ingredients are inexpensive.

Geographic coverage and international market dynamics

Dutoprol’s market position varies by country because fixed-dose combination approvals, brand names, reimbursement systems, and generic substitution rules differ.

In the United States, pharmacy substitution and generic reimbursement strongly limit brand pricing. In other markets, fixed-dose antihypertensive combinations may retain more share where physician prescribing, tender systems, or local brand loyalty reduce automatic substitution. Those markets remain price-sensitive and generally do not support a high-growth trajectory.

International revenue cannot be inferred from U.S. regulatory status. A country may maintain a marketed product even when the U.S. brand has little commercial activity.

Key Takeaways

• Dutoprol is a mature fixed-dose combination of metoprolol succinate extended release and hydrochlorothiazide.
• Its commercial rationale is reduced pill burden, not novel pharmacology.
• Regulatory and patent exclusivity no longer provide a material branded moat.
• Generic metoprolol, generic hydrochlorothiazide, and alternative combination therapies drive market erosion.
• No standalone Dutoprol revenue is publicly reported, preventing a precise brand-level financial forecast.
• The product is unlikely to be financially material to AstraZeneca’s consolidated business.
• Current risk is primarily generic substitution, low pricing, and supply economics rather than active patent litigation.
• Dutoprol has no biosimilar exposure because it is a small-molecule drug.
• Residual value depends on fixed-dose adherence benefits, local reimbursement, and continued product availability.

FAQs

Is Dutoprol still available in the United States?

Availability can vary by manufacturer, wholesaler, pharmacy, and FDA marketing-status records. Metoprolol and hydrochlorothiazide remain widely available through other products, even where branded Dutoprol distribution is limited.

Is Dutoprol the same as Toprol-XL?

No. Toprol-XL contains metoprolol succinate extended release alone. Dutoprol combines metoprolol succinate extended release with hydrochlorothiazide.

Can generic metoprolol replace Dutoprol?

Generic metoprolol does not replace the hydrochlorothiazide component. A clinician may prescribe separate generic metoprolol and hydrochlorothiazide, but substitution should follow the prescribed dosing regimen.

Does Dutoprol have a valuable patent portfolio?

No material active patent estate is known to preserve significant U.S. brand pricing power. Any patent analysis should distinguish historical patents from currently unexpired, enforceable Orange Book-listed patents.

Is Dutoprol commercially attractive for a generic manufacturer?

The product may offer a low-cost volume opportunity, but margins are likely constrained by mature hypertension pricing, multiple substitutes, limited brand demand, and manufacturing requirements for an extended-release combination tablet.

References

1. U.S. Food and Drug Administration. (2006). Dutoprol prescribing information. FDA Drugs@FDA database.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA database.

4. AstraZeneca PLC. (2006). Annual report and Form 20-F. AstraZeneca.

5. U.S. Food and Drug Administration. (2011). Guidance for industry: Bioavailability and bioequivalence studies submitted in NDAs or INDs: General considerations. FDA.