Last Updated: June 24, 2026

Piperacetazine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for piperacetazine and what is the scope of patent protection?

Piperacetazine is the generic ingredient in one branded drug marketed by Dow Pharm and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for piperacetazine.

Summary for piperacetazine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 43
DailyMed Link:piperacetazine at DailyMed

US Patents and Regulatory Information for piperacetazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dow Pharm QUIDE piperacetazine TABLET;ORAL 013615-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dow Pharm QUIDE piperacetazine TABLET;ORAL 013615-001 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
Last updated: February 15, 2026

What are the current market dynamics for piperacetazine?

Piperacetazine is an antipsychotic agent historically used to treat schizophrenia and related mental health conditions. Its market presence has significantly declined, primarily due to safety concerns, limited efficacy, and the advent of newer agents.

Market size for older antipsychotics like piperacetazine has contracted. The global antipsychotic drugs market reached approximately $7 billion in 2022, but piperacetazine's contribution is negligible, reflecting limited off-label use and declining prescription rates.

Key drivers include:

  • Patent status: No active patent protection since expired decades ago, leading to generic manufacturing and pricing pressures.
  • Regulatory environment: Manufacturers have discontinued marketing in many regions due to safety profile issues and market shifts.
  • Clinical preference: Safer, more effective atypical antipsychotics (e.g., risperidone, olanzapine) have replaced typical agents like piperacetazine.
  • Market adoption trends: Declining due to side effects associated with phenothiazine derivatives, including extrapyramidal symptoms.

What is the financial trajectory of piperacetazine?

Financially, piperacetazine's trajectory is limited to niche markets or legacy use:

  • Revenue: Negligible in recent years. No significant sales reported since the early 2000s.
  • Pricing: As a generic, the drug is sold at low prices, often below $10 per dose, with minimal profit margins for manufacturers.
  • Manufacturing: Continues in small-scale generic markets in regions with less regulatory oversight. No ongoing R&D investments observed.
  • Market exit: Most pharmaceutical companies have discontinued production; remaining supply is supplied through existing inventories or compounding pharmacies.

How do regulatory and patent policies impact piperacetazine?

  • Patent protection: Expired in the 1980s, enabling generic manufacturing.
  • Regulatory approval: Many regulatory agencies have de-listed piperacetazine from active registries due to safety concerns or low demand.
  • Reimbursement policies: Payors largely do not cover piperacetazine; coverage is limited to unspecified off-label uses in some regions.

What are the competitive options influencing piperacetazine's market position?

  • Atypical antipsychotics: Risperidone, olanzapine, quetiapine dominate due to improved side effect profiles.
  • Novel agents: Partial dopamine agonists (aripiprazole) and long-acting injectables have further displaced older drugs like piperacetazine.
  • Market consolidation: Fewer manufacturers produce typical antipsychotics, creating a further decline in piperacetazine-related activity.

What are future prospects for piperacetazine?

Limited. The drug's safety profile and competitive landscape suggest it will remain a legacy product, with negligible or zero growth prospects. Its potential resuscitation would require significant reformulation or new clinical indication approval, unlikely in current regulatory and market conditions.

Key Takeaways

  • Piperacetazine's market has largely disappeared, with minimal ongoing sales.
  • The drug faces safety concerns, obsolescence, and competitive displacement by newer agents.
  • No active patent protection; generic sales are low-priced and declining.
  • Regulatory agencies have largely de-listed or discontinued approval for the drug.
  • Future growth prospects are virtually nonexistent unless new indications or reformulations emerge.

FAQs

1. Is piperacetazine still available commercially?
It is available through some generic suppliers in select regions, mainly for legacy or compounding purposes.

2. Why is piperacetazine no longer widely used?
Because of safety concerns, side effects like extrapyramidal symptoms, and competition from newer antipsychotics with better tolerability.

3. Are there ongoing clinical trials for piperacetazine?
No notable clinical trials are ongoing, and most research has shifted towards developing or improving atypical antipsychotics.

4. What alternatives are preferred over piperacetazine?
Atypical antipsychotics such as risperidone, olanzapine, and quetiapine are preferred due to improved safety profiles.

5. Could piperacetazine regain market share?
Unlikely, given the safety profile, market dominance of newer agents, and lack of regulatory support.

References

  1. Market data sourced from Global Data, 2022.
  2. Drug safety and regulatory status from FDA and EMA archives, 2022.
  3. Industry analysis on antipsychotic market trends, IQVIA 2022.
  4. Patent status and generic availability details from U.S. Patent Office records, 2023.
  5. Clinical guidelines referencing antipsychotic treatment standards, American Psychiatric Association, 2022.

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.