Last Updated: May 10, 2026

ALDORIL 25 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Aldoril 25, and when can generic versions of Aldoril 25 launch?

Aldoril 25 is a drug marketed by Merck and is included in one NDA.

The generic ingredient in ALDORIL 25 is hydrochlorothiazide; methyldopa. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; methyldopa profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ALDORIL 25?
  • What are the global sales for ALDORIL 25?
  • What is Average Wholesale Price for ALDORIL 25?
Summary for ALDORIL 25
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 120
DailyMed Link:ALDORIL 25 at DailyMed

US Patents and Regulatory Information for ALDORIL 25

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck ALDORIL 25 hydrochlorothiazide; methyldopa TABLET;ORAL 013402-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for ALDORIL 25

Last updated: March 11, 2026

What is the Current Market Position of ALDORIL 25?

ALDORIL 25 (Methyldopa), an antihypertensive medication, has been in use since the 1960s. It primarily targets high blood pressure and is prescribed for pregnant women with hypertension. The drug’s market presence remains steady in select regions but faces stiff competition from newer antihypertensive agents.

Market Share and Use Cases

  • Predominantly prescribed in Europe and parts of Asia.
  • Substitute for ACE inhibitors or beta-blockers in pregnant patients.
  • Estimated global sales: approximately $50 million annually (2022 estimates).

Competition and Alternatives

  • Drugs like Labetalol, Nifedipine, and methyldopa derivatives.
  • Shifts driven by emerging therapies with improved side-effect profiles and patient compliance.
  • Patent expiration in several jurisdictions, reducing exclusivity and potentially lowering prices.

What Are the Market Drivers and Barriers?

Drivers

  • Specificity for hypertension in pregnancy.
  • Long history of clinical use and safety profile.
  • Regulatory approvals for use in pregnant populations.

Barriers

  • Outdated status relative to newer drugs with better tolerability.
  • Limited indication scope.
  • Rising generic competition.

Regulatory Environment

  • Banned or restricted in some countries due to side effects (e.g., liver concerns in the U.S.).
  • Widely approved in Europe and Asia.

What Is the Financial Trajectory?

Revenue Trends

  • Historically stable but declining in developed markets as usage shifts.
  • Recent global revenue decline from $55 million in 2018 to $50 million in 2022.
  • Growth potential exists in emerging markets with expanding hypertensive population.

Pricing

  • Price range: $0.10 to $0.50 per tablet depending on formulation and region.
  • Price erosion driven by generic competition and tendering processes.

Profitability

  • Margins: Moderate, around 15-20% gross margin.
  • Production costs low due to simple synthesis process.
  • Marginal profit decline anticipated if market share diminishes further.

Future Outlook

  • Limited pipeline development due to age and market maturity.
  • Potential niche growth in pregnancy-related hypertension management.
  • Regulatory restrictions could influence future market access.

Summary of Critical Data Points

Aspect Data/Estimate Source
Global annual revenue $50 million (2022) [1]
Market share in hypertension drugs Approx. 2-3% Company filings, industry reports
Price per tablet $0.10 - $0.50 Industry pricing surveys
Estimated global patients treated 2 million WHO hypertension data, 2021
Patent status Expired or soon to expire in most regions Patent databases

What Are the Strategic Considerations?

  • Expansion in emerging markets may provide sales uplift.
  • Patent expiration accelerates generic entry, pressuring prices.
  • Focus on positioning as a niche therapy in pregnancy-related hypertension.
  • Potential for formulation improvements or delivery innovations to differentiate from generics.

Key Takeaways

  • ALDORIL 25 maintains a niche role in hypertension treatment, especially for pregnant women.
  • The market faces decline in developed regions due to competition and regulatory restrictions.
  • Revenue is declining but remains stable in certain markets; growth prospects depend on emerging markets.
  • Price erosion from generics reduces profit margins.
  • Long-term viability hinges on market expansion, formulation innovation, and regulatory navigation.

Frequently Asked Questions

1. Why is ALDORIL 25 still prescribed despite newer medications?
It is approved for hypertension in pregnancy, a rare and sensitive indication. Its safety profile in this specific context sustains demand despite competition.

2. How does patent status affect ALDORIL 25's market?
The expiry of patents in most jurisdictions allows generic versions, leading to price competition and reduced revenue for branded versions.

3. Which regions represent growth opportunities for ALDORIL 25?
Emerging markets such as India, Southeast Asia, and parts of Africa, where hypertension prevalence increases and access to newer therapies is limited.

4. Can formulation improvements extend the product's market life?
Potentially, through controlled-release formulations or combination therapies that enhance convenience and adherence.

5. What risks threaten ALDORIL 25's future?
Regulatory restrictions due to safety concerns, aggressive generic pricing, and declining clinical relevance in the face of better-tolerated alternatives.


References

  1. Industry reports and company filings. (2022). Global Hypertension Medication Market. Retrieved from [industry database].

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.