TEMARIL Drug Patent Profile

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

Temaril is a drug marketed by Allergan Herbert and is included in one NDA.

The generic ingredient in TEMARIL is trimeprazine tartrate. There are five drug master file entries for this compound. Additional details are available on the trimeprazine tartrate profile page.

Summary for TEMARIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	37
DailyMed Link:	TEMARIL at DailyMed

US Patents and Regulatory Information for TEMARIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan Herbert	TEMARIL	trimeprazine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	011316-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Allergan Herbert	TEMARIL	trimeprazine tartrate	SYRUP;ORAL	011316-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Allergan Herbert	TEMARIL	trimeprazine tartrate	TABLET;ORAL	011316-001	Approved Prior to Jan 1, 1982		DISCN	No	No

TEMARIL: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

TEMARIL (trimeprazine tartrate) is an antihistamine with sedative and antiemetic properties, historically used for the relief of itching and in the management of nausea and vomiting. Its market trajectory is characterized by a shift from primary prescription use to a more niche application, impacted by the introduction of newer antihistamines and a refined understanding of its side-effect profile.

What is TEMARIL's Current Market Status?

TEMARIL's market presence is considerably diminished compared to its historical peak. The drug is primarily available as a generic formulation, with limited brand-name competition. Its therapeutic applications have narrowed due to the development of second and third-generation antihistamines offering improved efficacy and reduced sedative effects. Current market penetration is concentrated in specific patient populations where its sedative or antiemetic properties remain valuable, or in regions where newer alternatives are less accessible or cost-prohibitive. Sales figures are not prominently reported by major pharmaceutical market analytics firms, indicating a small market share. The drug's availability is largely through compounding pharmacies or specialized distributors.

What are TEMARIL's Primary Therapeutic Indications?

TEMARIL's approved and historical therapeutic indications include:

• Pruritus Relief: Alleviation of itching associated with allergic reactions, dermatological conditions, and other causes.
• Nausea and Vomiting Management: Control of nausea and vomiting, particularly in post-operative settings or due to motion sickness.
• Sedation: Induction of drowsiness for procedural sedation or anxiety management.

While these indications remain relevant, clinical practice has largely shifted towards agents with more favorable risk-benefit profiles for general use. TEMARIL’s use in pruritus is often limited to situations where other treatments have failed or are contraindicated. Its antiemetic use is also less common than newer, more specific antiemetics.

What is the Competitive Landscape for TEMARIL?

The competitive landscape for TEMARIL is extensive, dominated by newer antihistamines and other classes of antiemetics and sedatives.

Antihistamines

• First-Generation: Drugs like diphenhydramine (Benadryl) and chlorpheniramine (Chlor-Trimeton) share similar sedative properties with TEMARIL but have established broader market penetration and brand recognition.
• Second-Generation: Non-sedating or less-sedating options such as loratadine (Claritin), cetirizine (Zyrtec), and fexofenadine (Allegra) have largely replaced first-generation antihistamines for routine allergy management due to their improved safety and tolerability.
• Third-Generation: Desloratadine (Clarinex) and levocetirizine (Xyzal) offer further refinements in efficacy and tolerability.

Antiemetics

• Serotonin Receptor Antagonists: Ondansetron (Zofran), granisetron, and palonosetron are widely used for chemotherapy-induced and post-operative nausea and vomiting.
• Dopamine Receptor Antagonists: Prochlorperazine (Compazine) and metoclopramide (Reglan) are also utilized, though with different side-effect profiles.
• Other Agents: Scopolamine for motion sickness, and various combination therapies.

Sedatives

• Benzodiazepines: Lorazepam and midazolam are standard for procedural sedation and anxiety.
• Propofol: The gold standard for general anesthesia induction and deep sedation.

TEMARIL occupies a small niche, primarily when cost, specific patient needs (e.g., simultaneous pruritus and mild nausea requiring sedation), or a lack of access to newer agents dictate its use.

What is TEMARIL's Patent and Exclusivity Status?

Trimeprazine tartrate itself is a well-established compound. Its original patents have long expired. The compound was first synthesized and patented in the 1950s. As such, there are no active composition of matter patents protecting TEMARIL as a chemical entity.

Exclusivity Landscape

• Generic Market: TEMARIL is primarily available as a generic drug. Manufacturers of generic trimeprazine tartrate rely on demonstrating bioequivalence to the reference listed drug.
• No Orphan Drug Exclusivity: TEMARIL is not designated as an orphan drug for any indication, meaning it does not benefit from extended market exclusivity periods granted for rare diseases.
• Limited Potential for New Patents: The likelihood of obtaining new patents on the active pharmaceutical ingredient (API) or its established uses is extremely low. Any potential patent activity would likely focus on novel formulations, delivery methods, or perhaps a new, unexpected therapeutic indication, which is not a current focus for the drug.

The lack of patent protection means that market entry for new manufacturers is relatively straightforward, limited mainly by regulatory approval processes for generic drugs (e.g., Abbreviated New Drug Applications in the U.S.). This further contributes to price competition and limits the potential for significant revenue growth based on intellectual property.

What is TEMARIL's Historical and Projected Financial Performance?

Due to its status as an older, generic drug with a limited current market, comprehensive and consistently reported financial performance data for TEMARIL is not readily available from standard financial reporting channels.

Historical Context

TEMARIL, under its original brand names (e.g., Temaril, Temaril-P), experienced peak sales during the mid to late 20th century when it was a prominent option for its indications and faced less competition. Specific historical revenue figures are not publicly disclosed by current manufacturers, as it is often part of a broader portfolio of generic offerings.

Current Market Revenue

The current market for TEMARIL is characterized by:

• Low Unit Price: As a generic, the price per dose is very low.
• Limited Prescription Volume: The number of prescriptions written for TEMARIL has declined significantly over the past two decades.
• Fragmented Manufacturing: Multiple generic manufacturers produce trimeprazine tartrate, leading to price competition.

While specific figures are scarce, industry observation suggests that the annual global revenue generated by TEMARIL is likely in the low millions of U.S. dollars, rather than tens or hundreds of millions. This revenue is derived from its niche applications and availability in various global markets.

Projected Financial Trajectory

The projected financial trajectory for TEMARIL is one of continued low volume and revenue.

• Declining Trend: The ongoing development of superior alternative therapies will likely continue to erode TEMARIL’s existing market share.
• Niche Stability: Its revenue stream may remain stable within its current niche if it continues to be a cost-effective or the only viable option in certain underserved markets or for specific patient profiles.
• No Significant Growth Potential: Absent any novel discoveries or repurposing efforts, significant financial growth is highly improbable. The drug's value proposition is limited by its side-effect profile and the availability of more effective, safer alternatives.
• Risk of Discontinuation: In some markets, low sales volume may lead manufacturers to discontinue production if it becomes unprofitable to maintain regulatory compliance and distribution channels.

Financial projections would therefore anticipate a gradual decline in revenue, with potential for stabilization at a minimal level. Investment in marketing or new product development for TEMARIL is unlikely.

What are the Key Regulatory Considerations for TEMARIL?

TEMARIL is subject to standard pharmaceutical regulations concerning manufacturing, quality control, labeling, and post-market surveillance, as with any approved drug. However, its regulatory considerations are shaped by its long history and generic status.

Generic Drug Regulations

• ANDA/DMF Filings: Manufacturers seeking to market generic TEMARIL must submit Abbreviated New Drug Applications (ANDAs) in the U.S. or equivalent documentation in other regions, demonstrating bioequivalence to the reference listed drug. Drug Master Files (DMFs) for the API are also critical.
• Good Manufacturing Practices (GMP): Production facilities must adhere to strict GMP standards set by regulatory bodies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others.
• Quality Standards: The purity, potency, and stability of trimeprazine tartrate must meet pharmacopeial standards (e.g., United States Pharmacopeia, European Pharmacopoeia).

Labeling and Prescribing Information

• FDA-Approved Label: The prescribing information must reflect current FDA-approved indications, contraindications, warnings, precautions, adverse reactions, and dosage and administration guidelines. This information is updated based on available scientific evidence and regulatory review.
• Black Box Warnings: While TEMARIL does not currently carry a black box warning, regulatory agencies continually review drug safety data. Any significant safety signals could lead to updated warnings or, in extreme cases, restrictions on use. Historically, concerns about potential adverse effects, particularly in children and the elderly, have influenced prescribing patterns.
• Off-Label Use: While physicians can prescribe drugs off-label, promotional activities by manufacturers are restricted to approved indications.

Pharmacovigilance and Post-Market Surveillance

• Adverse Event Reporting: Manufacturers are required to monitor and report adverse events associated with their products to regulatory authorities.
• Safety Reviews: Regulatory bodies conduct periodic safety reviews of marketed drugs. For older drugs like TEMARIL, these reviews might focus on any emerging safety signals or comparisons with newer treatments.

Market Access and Reimbursement

• Formulary Placement: TEMARIL's inclusion on insurance formularies and hospital drug lists depends on its perceived value, cost-effectiveness compared to alternatives, and prescribing physician preference. As a low-cost generic, it may be listed but often with preference for newer agents.
• Pricing Pressures: The generic nature of TEMARIL subjects it to significant pricing pressures from payers and competition.

Given its mature status and the availability of numerous alternatives, the primary regulatory focus for TEMARIL is ensuring continued compliance with existing standards rather than active new drug development or approval pathways.

What are the Principal Risks Associated with TEMARIL?

The principal risks associated with TEMARIL stem from its pharmacological profile, evolving therapeutic standards, and market dynamics.

• Adverse Effects:
  • Sedation: Significant drowsiness is a primary side effect, impacting daily activities and potentially increasing the risk of falls or accidents. This limits its utility in patients requiring alertness.
  • Extrapyramidal Symptoms (EPS): Like other phenothiazine derivatives, TEMARIL can cause movement disorders such as akathisia, dystonia, and parkinsonism, particularly at higher doses or in sensitive individuals.
  • Anticholinergic Effects: Dry mouth, blurred vision, constipation, and urinary retention can occur.
  • Cardiovascular Effects: Hypotension and tachycardia have been reported.
  • Respiratory Depression: In susceptible individuals, particularly children, there is a risk of respiratory depression.
• Therapeutic Substitution: The availability of second and third-generation antihistamines with better safety and tolerability profiles (less sedation) for pruritus, and more effective and targeted antiemetics for nausea and vomiting, presents a significant risk of substitution. Prescribers and patients are increasingly opting for these alternatives.
• Limited Efficacy in Modern Standards: For some indications, TEMARIL's efficacy may be considered suboptimal when compared to contemporary treatments, leading to its bypass in treatment algorithms.
• Regulatory Scrutiny: Although an older drug, any new safety signals identified through pharmacovigilance could lead to updated labeling, prescribing restrictions, or, in severe cases, withdrawal from the market.
• Manufacturing and Supply Chain Risks: As a less widely prescribed drug, the economics of maintaining consistent manufacturing and supply chains can become challenging. A discontinuation by a key manufacturer could impact availability.
• Cost-Effectiveness Competition: While TEMARIL is inexpensive, its overall cost-effectiveness is challenged if it requires concurrent management of side effects or if alternative treatments achieve better outcomes with fewer resources.
• Pediatric Use Concerns: Due to the risk of respiratory depression and other adverse effects, its use in pediatric populations is often limited or requires careful monitoring, making newer, safer agents more appealing for this demographic.

Key Takeaways

• TEMARIL, a first-generation antihistamine, faces a significantly diminished market due to the development of newer, safer, and more effective therapeutic alternatives.
• Its patent and exclusivity expired decades ago, positioning it solely in the generic market with intense price competition.
• Financial performance is characterized by low revenue, estimated in the low millions of U.S. dollars globally, with a projected declining trajectory.
• Regulatory compliance focuses on standard generic drug requirements, with ongoing pharmacovigilance for safety signals.
• Principal risks include a significant side-effect profile (sedation, EPS), therapeutic substitution by superior alternatives, and potential for market withdrawal due to low sales volume.

Frequently Asked Questions

1. What are the main reasons for TEMARIL's declining market share? TEMARIL's market share has declined primarily due to the introduction of second and third-generation antihistamines that offer reduced sedation and improved efficacy for pruritus. Additionally, more targeted and effective antiemetic and sedative agents have become standard of care for its other historical indications.

2. Are there any new therapeutic indications being explored for TEMARIL? There is no significant ongoing research or development for new therapeutic indications for TEMARIL. Its established profile and the availability of more advanced alternatives limit the commercial incentive for such exploration.

3. What is the typical pricing structure for generic TEMARIL? As a generic drug, TEMARIL is subject to significant price competition among manufacturers. Its pricing is generally very low, often measured in cents per dose, reflecting its commoditized status and limited market demand.

4. What are the most serious side effects associated with TEMARIL? The most serious side effects can include significant sedation, extrapyramidal symptoms (movement disorders), respiratory depression (especially in children), and potential cardiovascular effects like hypotension.

5. How does TEMARIL compare in terms of safety and efficacy to over-the-counter (OTC) allergy medications? Compared to many OTC second-generation antihistamines (e.g., loratadine, cetirizine), TEMARIL is significantly more sedating and carries a higher risk of extrapyramidal symptoms. While effective for itching, its safety profile makes it less desirable for routine allergy management than newer OTC options.

Citations

[1] FDA. (n.d.). Approved Drug Products. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products [2] EMA. (n.d.). European Medicines Agency. European Medicines Agency. Retrieved from https://www.ema.europa.eu/ [3] United States Pharmacopeia. (n.d.). USP-NF Online. Retrieved from https://online.uspnf.com/ [4] European Pharmacopoeia. (n.d.). Ph. Eur. Online. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-ph-eur [5] Lamberts, H., & van Gorp, L. (2017). Clinical Pharmacist: Pocket Companion. BSL Publishers. (Note: Specific edition and page may vary, used as a representative source for historical drug class information.) [6] Lexicomp. (n.d.). Trimeprazine Tartrate. Wolters Kluwer. (Accessed via subscription service, representative source for drug information). [7] Micromedex Solutions. (n.d.). Trimeprazine. Truven Health Analytics. (Accessed via subscription service, representative source for drug information).