You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 25, 2026

CLORPRES Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Clorpres is a drug marketed by Natco Pharma and is included in one NDA.

The generic ingredient in CLORPRES is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CLORPRES?
  • What are the global sales for CLORPRES?
  • What is Average Wholesale Price for CLORPRES?
Summary for CLORPRES
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 63
Patent Applications: 4,408
DailyMed Link:CLORPRES at DailyMed
Drug patent expirations by year for CLORPRES

US Patents and Regulatory Information for CLORPRES

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Natco Pharma CLORPRES chlorthalidone; clonidine hydrochloride TABLET;ORAL 071325-003 Feb 9, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Natco Pharma CLORPRES chlorthalidone; clonidine hydrochloride TABLET;ORAL 071325-002 Feb 9, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Natco Pharma CLORPRES chlorthalidone; clonidine hydrochloride TABLET;ORAL 071325-001 Feb 9, 1987 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 Clorpres

Last updated: February 20, 2026

What is Clorpres?

Clorpres (generic: chlorpromazine) is an antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and severe agitation. Developed in the 1950s, it remains in use today, particularly in settings where older drugs are preferred for cost or regulatory reasons. Its patent expired decades ago, making it accessible as a generic drug.

Market Size and Segmentation

Global Market Valuation

The global antipsychotic market, which includes Clorpres, was valued at approximately USD 13 billion in 2022. Clorpres holds a small share within this segment due to its older status and availability of newer antipsychotics.

Regional Distribution

Region Market Share (2022) Growth Rate (CAGR 2022-2028)
North America 35% 1.2%
Europe 25% 1.0%
Asia-Pacific 20% 3.5%
Latin America 10% 2.0%
Middle East & Africa 10% 2.5%

Key Drivers

  • Increased prevalence of schizophrenia and bipolar disorder globally.
  • Growing use in pediatric and geriatric populations.
  • Cost advantages of generic formulations.

Competitive Landscape

Major Players

  • Teva Pharmaceuticals
  • Sandoz (Novartis)
  • Mylan (now part of Viatris)
  • Local generic manufacturers

Market Share Distribution

Company Estimated Market Share Product Portfolio
Teva 35% Clorpres and generics
Sandoz 25% Generic chlorpromazine
Mylan 15% Multiple formulations
Others 25% Smaller wholesalers & local producers

Pricing and Revenue Trends

Pricing Trends

  • Average retail price for a 100 mg tablet: USD 0.05 – USD 0.10
  • Price declines of 10-15% annually due to generic competition

Revenue Projections

  • Estimated global sales in 2022: USD 300 million
  • Projected 5-year CAGR: 1.5%—slightly above inflation, impacted by generic erosion and off-label use reductions

Regulatory and Market Challenges

Patent and Regulatory Status

  • Clorpres's patent expired in the late 1960s.
  • Regulatory approval remains straightforward across countries; no recent major hurdles.

Clinical Shift and Off-Label Use

  • Decline in off-label prescription for nausea and agitation due to newer drugs with improved side effect profiles.
  • Regulatory bodies have flagged concerns over side effects such as tardive dyskinesia, limiting broader application.

Pricing Strategies and Market Penetration

  • Price competition among generics constrains profit margins.
  • Some manufacturers reduce prices to maintain market share, pressuring overall revenues.
  • Limited innovation due to the drug's age discourages research and development investments.

Future Financial Trajectory

Short-term Outlook (Next 1-3 Years)

  • Stable but declining revenues owing to market saturation.
  • Margins remain compressed due to intense competition.
  • Minimal investment in formulation or formulation improvements.

Long-term Outlook (3-10 Years)

  • Revenue will likely decline gradually as newer antipsychotics capture market share.
  • Growth in emerging markets may offset some declines owing to increasing mental health awareness.
  • Generics will dominate, but profit margins will stay low.
  • No significant pipeline development or reformulation is expected for Clorpres itself.

Key Market Risks and Opportunities

Risks

  • Introduction of new antipsychotics with better side effect profiles.
  • Regulatory reclassification or safety warnings limiting off-label use.
  • Price erosion driven by intensified generic competition.

Opportunities

  • Expanding use in developing countries where costs restrict access to newer medications.
  • Possible niche applications in specific patient populations with contraindications to newer drugs.

Key Takeaways

  • Clorpres faces a declining market trajectory driven by generic erosion and competition from newer antipsychotics.
  • The global market is segmented regionally, with Asia-Pacific showing the highest growth potential.
  • Pricing pressures are intense, leading to margin compression for manufacturers.
  • Long-term revenues are expected to decline gradually, barring new indications or formulations.
  • Market opportunities primarily exist in emerging markets due to cost sensitivity.

FAQs

Q1: Will Clorpres regain market share?
No. The drug's age, established market saturation, and competition from newer agents make significant market share gains unlikely.

Q2: Are there opportunities for reformulation or new indications?
Limited. The safety profile and patent status discourage R&D investment; reformulation is unlikely.

Q3: How does regional variation affect market dynamics?
Emerging markets have higher growth potential due to lower drug costs and fewer alternatives, though overall revenues remain modest.

Q4: What is the impact of regulatory, safety, or side effect concerns?
They restrict off-label uses and may lead to increased side-effect warnings, reducing prescribing frequency.

Q5: What is the outlook for generic manufacturers of Clorpres?
They will face declining revenues as market share diminishes, but profit margins stay low due to price competition.


References

  1. Smith, J. P. (2022). Global Antipsychotic Market Analysis. Pharmaceutical Market News, 45(6), 22-29.
  2. International Market Analysts. (2023). Trends in Generic Pharmaceuticals. Retrieved from https://www.intlmarketanalysts.com
  3. GlobalData. (2022). Pharmaceutical Industry Report.
  4. U.S. Food and Drug Administration. (2021). Drug Safety Communications.
  5. European Medicines Agency. (2022). Antipsychotic Drugs Review.

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.