Propiomazine hydrochloride - Generic Drug Details
What are the generic sources for propiomazine hydrochloride and what is the scope of patent protection?
Propiomazine hydrochloride
is the generic ingredient in one branded drug marketed by Hikma and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for propiomazine hydrochloride
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| DailyMed Link: | propiomazine hydrochloride at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for propiomazine hydrochloride
US Patents and Regulatory Information for propiomazine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | LARGON | propiomazine hydrochloride | INJECTABLE;INJECTION | 012382-002 | 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 |
Propiomazine Hydrochloride Market Dynamics and Financial Trajectory
Propiomazine hydrochloride is a mature, low-cost prescription hypnotic with limited geographic commercialization and no identifiable modern originator exclusivity. Its principal remaining market is Sweden, where it is sold as Propavan 25 mg tablets. Public company filings do not disclose standalone revenue for propiomazine, and the product has no meaningful U.S. commercial footprint. Financial prospects are therefore tied to stable niche demand, generic manufacturing economics, regulatory maintenance and substitution by newer insomnia therapies rather than patent-driven pricing power.
What is propiomazine hydrochloride and how is it used?
Propiomazine is a phenothiazine derivative used primarily as a sedative and hypnotic. It is chemically related to older phenothiazine compounds but is marketed for insomnia rather than as a modern antipsychotic.
| Attribute | Propiomazine hydrochloride |
|---|---|
| Active ingredient | Propiomazine |
| Salt form | Hydrochloride |
| Therapeutic category | Prescription hypnotic and sedative |
| Principal marketed strength | 25 mg tablet |
| Known European brand | Propavan |
| Primary commercial market | Sweden |
| U.S. FDA approval status | No current FDA-approved product identified |
| Biosimilar relevance | Not applicable |
| Current patent-driven exclusivity | None identified for the core molecule |
| Market type | Mature, generic or near-generic niche |
The Swedish product information identifies Propavan as a 25 mg tablet containing propiomazine and indicates use for short-term treatment of sleep disturbances [1]. The product is not positioned as a first-line modern insomnia therapy in the manner of dual orexin receptor antagonists such as daridorexant or suvorexant.
What is the FDA and Orange Book status of propiomazine hydrochloride?
Propiomazine hydrochloride does not have a meaningful U.S. FDA commercial status. It is not identified as an actively marketed FDA-approved prescription product in the standard Drugs@FDA and Orange Book framework [2,3].
U.S. regulatory position
The practical U.S. position is:
- No established U.S. brand franchise.
- No Orange Book-listed reference product with a visible commercial market.
- No material U.S. Abbreviated New Drug Application competition.
- No identifiable U.S. Paragraph IV litigation landscape.
- No current U.S. exclusivity period of commercial relevance.
Because the product lacks a current U.S. reference-product market, conventional Hatch-Waxman analysis has little value. A U.S. entrant would face regulatory, clinical and commercial establishment costs without the benefit of a large existing market.
European regulatory position
European availability is country-specific. Propavan has been associated primarily with the Swedish prescription market. National marketing authorization data, rather than a broad European centralized authorization, are the relevant regulatory source for the product [1,4].
When did propiomazine lose exclusivity?
The core propiomazine compound is an older small molecule whose original patent protection would have expired decades ago. No current composition-of-matter exclusivity has been identified in the public regulatory and patent records reviewed for the marketed product.
| Exclusivity category | Current assessment |
|---|---|
| Original compound patent | Expired or no longer commercially relevant |
| U.S. NCE exclusivity | None identified |
| European regulatory exclusivity | Expired |
| Current formulation exclusivity | No material active protection identified |
| Method-of-use exclusivity | No material active protection identified |
| Orphan-drug exclusivity | Not applicable |
| Pediatric exclusivity | Not applicable |
| Biosimilar exclusivity | Not applicable |
The commercial implication is straightforward: pricing depends on manufacturing cost, local competition, reimbursement and prescriber familiarity. Patent expiration is not a future catalyst or cliff because the product is already in the post-exclusivity phase.
What patents protect propiomazine hydrochloride?
No active patent estate with material commercial significance has been identified for the core propiomazine hydrochloride product.
Composition and formulation patents
Propiomazine was developed before the current pharmaceutical patent lifecycle became commercially important for most prescription products. Any original compound or basic formulation patents would be expected to have expired. The marketed 25 mg tablet does not appear to depend on a recent delivery technology, extended-release platform or proprietary device.
Potential residual rights could theoretically relate to:
- A country-specific tablet formulation.
- Manufacturing controls or process know-how.
- Packaging or stability systems.
- Trademark rights for Propavan.
- Regulatory dossier ownership or data access.
These rights differ from patent exclusivity. They may affect market entry operationally but do not create a durable barrier comparable to an active composition patent.
Manufacturing and intellectual-property barriers
The principal barriers are likely operational:
- Sourcing a qualified active pharmaceutical ingredient.
- Demonstrating compliance with current good manufacturing practice requirements.
- Maintaining product quality and stability.
- Securing national marketing authorization.
- Establishing distribution through pharmacies and wholesalers.
The molecule itself is unlikely to present a high technical barrier. Its low volume can be a larger commercial obstacle because a manufacturer may not achieve attractive scale economics without a reliable national market.
Are there Paragraph IV challenges or generic litigation?
No major Paragraph IV challenge or U.S. patent litigation campaign involving propiomazine hydrochloride has been identified.
That result is consistent with the product’s commercial profile. Paragraph IV litigation is generally used when a branded product has substantial U.S. sales and an active Orange Book patent estate. Propiomazine lacks both conditions in the United States.
| Litigation issue | Assessment |
|---|---|
| U.S. Paragraph IV certification | No material public activity identified |
| ANDA litigation | No material public activity identified |
| Orange Book patent dispute | None identified |
| European opposition | No material public dispute identified |
| Settlement agreement | None identified |
| Product liability litigation | No major public case identified in the reviewed sources |
The absence of litigation should not be interpreted as evidence of a large unserved market. It primarily reflects the absence of a valuable U.S. patent-protected franchise.
What formulations are protected by propiomazine patents?
No commercially important active formulation patent has been identified for the standard 25 mg tablet.
The marketed dosage form is a conventional immediate-release oral tablet. This limits formulation differentiation. A new entrant would likely compete through:
- Price.
- Supply reliability.
- National reimbursement status.
- Wholesaler access.
- Tablet presentation.
- Regulatory and quality performance.
A new extended-release or modified-release formulation could create a differentiated product, but it would require clinical and regulatory investment. The market size would make that strategy difficult to justify unless the product demonstrated a clear safety or adherence advantage.
How does propiomazine compare with competing insomnia drugs?
Propiomazine competes in a mature hypnotic market with newer products that have stronger commercial positioning and, in some countries, active patent protection.
| Product or class | Mechanism or profile | Patent position | Commercial position |
|---|---|---|---|
| Propiomazine | Phenothiazine-derived sedative | Mature, no meaningful core exclusivity | Low-cost niche |
| Zopiclone | Cyclopyrrolone hypnotic | Mature generic market | Broad European use |
| Zolpidem | Imidazopyridine hypnotic | Mature generic market | Large historical use |
| Benzodiazepines | GABAergic sedatives | Mature generic market | Established but safety-limited |
| Melatonin products | Circadian regulator | Mostly generic or formulation-specific | Consumer and prescription segments |
| Daridorexant | Dual orexin receptor antagonist | Recent product patents and exclusivity | Premium newer therapy |
| Suvorexant | Dual orexin receptor antagonist | Patent-protected in selected markets | Branded insomnia product |
| Lemborexant | Dual orexin receptor antagonist | Patent-protected in selected markets | Branded insomnia product |
Propiomazine’s commercial advantage is low product cost and established prescriber familiarity in its remaining markets. Its disadvantages include an older safety and tolerability profile, limited geographic availability and weak ability to command premium pricing.
What is the market size and revenue exposure?
Public sources do not report standalone global sales for propiomazine hydrochloride. Neither the active ingredient nor Propavan appears to be a material revenue contributor in the public financial reporting of major multinational pharmaceutical companies.
The product’s revenue exposure is best characterized as:
- Concentrated in a small number of national markets.
- Predominantly prescription-based.
- Low value per treatment course.
- Sensitive to generic substitution and reimbursement controls.
- Unlikely to affect the financial outlook of a diversified pharmaceutical company.
Financial trajectory
The product’s likely financial trajectory has four stages:
| Period | Financial profile |
|---|---|
| Historical launch period | Protected or semi-protected product economics, depending on market |
| Post-patent period | Price erosion and expansion of generic alternatives |
| Current phase | Stable but small mature-market revenue |
| Forward outlook | Flat to declining nominal sales, with possible short-term increases from supply shortages or competitor withdrawal |
The absence of disclosed molecule-level sales prevents a reliable estimate of revenue, gross margin or market share. The business case is more consistent with a portfolio-maintenance product than with a growth asset.
Revenue drivers
Revenue can be supported by:
- Continued Swedish prescribing.
- Limited competition in specific national formularies.
- Physician familiarity with the product.
- Availability of low-cost manufacturing.
- Short-term shortages affecting alternative hypnotics.
Revenue is constrained by:
- Generic substitution.
- Reduced use of older sedatives.
- Safety concerns associated with phenothiazine-derived compounds.
- Prescriber migration toward newer insomnia medicines.
- Small addressable markets.
- Low price per tablet.
What is the competitive landscape for Propavan?
Propavan’s strongest competition is likely from other established hypnotics rather than from a direct proprietary propiomazine substitute. In Sweden and comparable European markets, prescribers can select from zopiclone, zolpidem, benzodiazepines, melatonin and newer insomnia therapies.
The competitive landscape has three tiers:
Low-cost legacy hypnotics
These products compete directly for price-sensitive prescriptions. Their markets are mature and their patent estates are generally expired.
Newer insomnia products
Dual orexin receptor antagonists compete on newer mechanisms and potentially differentiated safety or efficacy profiles. They are more exposed to patent expiry timing and reimbursement restrictions but can achieve higher prices.
Nonprescription and behavioral alternatives
Melatonin, sleep-behavior programs and digital or primary-care interventions can reduce demand for prescription sedatives. These alternatives are especially relevant for long-term insomnia management.
What licensing deals involve propiomazine hydrochloride?
No major publicly disclosed licensing, co-development or acquisition transaction centered on propiomazine hydrochloride has been identified.
The product’s commercial structure is more likely to involve national marketing authorization arrangements, distribution contracts or generic supply agreements than strategic global licensing. Trademark and dossier rights may have local value, but there is no evidence of a high-value platform transaction.
What generic launch risks exist?
A generic launch would carry low patent risk but meaningful commercial risk.
| Risk | Impact |
|---|---|
| Patent invalidity or infringement | Low |
| Regulatory approval | Moderate |
| API availability | Moderate |
| Market size | High |
| Price competition | High |
| Reimbursement access | Moderate to high |
| Pharmacovigilance burden | Moderate |
| Product discontinuation risk | Moderate |
| Supply-chain disruption | Moderate |
The central risk is market insufficiency. A manufacturer could obtain approval but still fail to generate adequate returns because annual demand is too small to support dedicated production, registration and pharmacovigilance expenses.
What is the geographic coverage of propiomazine hydrochloride?
Commercial coverage is narrow compared with widely used hypnotics.
Sweden is the clearest current market associated with Propavan. Availability in other countries may be historical, limited, or dependent on local registrations. The product should not be treated as a broadly commercialized European or global pharmaceutical.
Geographic concentration creates both risk and stability:
- A national reimbursement change can materially affect total sales.
- A local supply interruption can produce a sharp temporary revenue increase.
- A manufacturer can preserve a niche position without competing globally.
- Expansion into new countries would require country-specific regulatory and commercial investment.
How strong is the patent estate for propiomazine hydrochloride?
The patent estate is weak from a current commercial perspective.
| Patent-estate factor | Rating |
|---|---|
| Active composition patent | Very weak or absent |
| Active formulation patent | Weak |
| Method-of-use protection | Weak |
| Regulatory exclusivity | Expired |
| Manufacturing know-how | Potentially moderate |
| Trademark protection | Potentially relevant locally |
| Litigation deterrence | Very weak |
| Ability to support premium pricing | Very weak |
The product’s defensibility depends on execution, not exclusionary intellectual property. A national supplier with an established registration and dependable distribution may retain a niche position, but that position would not prevent a technically qualified competitor from entering where regulatory and commercial conditions support entry.
Key Takeaways
- Propiomazine hydrochloride is an old, mature hypnotic with limited current geographic commercialization.
- Propavan 25 mg is the principal identifiable marketed product, particularly in Sweden.
- No material current U.S. FDA, Orange Book or Paragraph IV market has been identified.
- The core molecule and conventional tablet formulation have no meaningful modern patent protection.
- Public companies do not disclose standalone revenue, and the product is unlikely to represent material corporate revenue exposure.
- The market is stable to declining, with temporary upside possible during shortages of competing hypnotics.
- Generic entry risk is legally low but commercially constrained by small market size and weak pricing power.
- Manufacturing, regulatory maintenance and distribution are more important barriers than patents.
- Biosimilar analysis is not applicable because propiomazine is a small-molecule drug.
- The product is better viewed as a niche portfolio-maintenance asset than as a growth or licensing opportunity.
FAQs
Is propiomazine hydrochloride still sold in the United States?
No current U.S. FDA-approved commercial product with propiomazine hydrochloride as the active ingredient has been identified in standard FDA product databases [2,3].
Is Propavan a generic drug?
Propavan is a branded national-market product containing the mature active ingredient propiomazine. Its commercial economics resemble those of a legacy generic or off-patent product, even where the brand remains recognized.
Does propiomazine hydrochloride have biosimilar competition?
No. Biosimilars apply to biologic products. Propiomazine hydrochloride is a conventional small-molecule drug and would be subject to generic-drug, not biosimilar, competition.
Can a company develop a new patented propiomazine product?
A company could pursue a new formulation, combination or delivery system, but any patent would need to protect a genuinely novel and non-obvious product attribute. The commercial opportunity would be limited by the small existing market and competition from other insomnia therapies.
Is propiomazine hydrochloride an attractive acquisition target?
It is unlikely to be attractive as a standalone acquisition because sales are geographically concentrated, public revenue data are limited and the product lacks meaningful patent exclusivity. Its value would be higher as part of a broader mature-products portfolio with shared manufacturing and distribution infrastructure.
References
- FASS. (n.d.). Propavan 25 mg tablet: Product information. Swedish Association of the Pharmaceutical Industry. https://fass.se
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
- European Medicines Agency. (n.d.). Medicines database and national authorization information. https://www.ema.europa.eu/en/medicines-available-european-union-repository-human-medicines-national-authorisation-registers
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