PROLOPRIM Drug Patent Profile

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

Proloprim is a drug marketed by Monarch Pharms and is included in one NDA.

The generic ingredient in PROLOPRIM is trimethoprim. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the trimethoprim profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proloprim

A generic version of PROLOPRIM was approved as trimethoprim by DR REDDYS LABS SA on July 30^th, 1982.

Summary for PROLOPRIM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	1
Patent Applications:	4,906
DailyMed Link:	PROLOPRIM at DailyMed

Recent Clinical Trials for PROLOPRIM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Sulaimani	N/A

See all PROLOPRIM clinical trials

US Patents and Regulatory Information for PROLOPRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Monarch Pharms	PROLOPRIM	trimethoprim	TABLET;ORAL	017943-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Monarch Pharms	PROLOPRIM	trimethoprim	TABLET;ORAL	017943-003	Jul 14, 1982		DISCN	No	No

Proloprim Market Dynamics and Financial Trajectory

Last updated: August 14, 2026

Proloprim is the legacy brand name for trimethoprim, an oral antibacterial used primarily for treatment of uncomplicated urinary tract infections. Its commercial trajectory is defined by patent expiry, generic substitution, low manufacturing complexity, and limited brand differentiation. Proloprim has no meaningful remaining exclusivity moat in the U.S.; value resides in established prescribing recognition, regulatory history, and supply reliability rather than in intellectual property.

Product-level revenue for Proloprim is not publicly disclosed. The product is generally sold within broader generic and legacy-branded portfolios, preventing a reliable standalone revenue estimate. The available evidence supports a mature-to-declining commercial profile with low unit economics and limited strategic value except for manufacturers with efficient production and distribution.

What is Proloprim and how is trimethoprim used?

Proloprim contains trimethoprim, a dihydrofolate reductase inhibitor. It is supplied in oral tablet strengths, historically including 100 mg and 200 mg. The FDA-approved labeling identifies treatment of initial episodes of uncomplicated urinary tract infections caused by susceptible organisms, including certain strains of Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species, and coagulase-negative Staphylococcus species.[1]

Attribute	Proloprim
Active ingredient	Trimethoprim
Drug class	Antibacterial; dihydrofolate reductase inhibitor
Primary U.S. use	Uncomplicated urinary tract infections
Dosage form	Oral tablet
Historical strengths	100 mg and 200 mg
U.S. regulatory pathway	Original NDA, followed by generic ANDAs
Market status	Legacy branded product in a mature generic market
Biosimilar exposure	Not applicable
Current patent moat	No material branded exclusivity identified

Trimethoprim is also used in other clinical settings, including Pneumocystis jirovecii pneumonia treatment and prophylaxis, often in combination with sulfamethoxazole. Those uses are not equivalent to the narrow Proloprim label and may involve different products, dosing, or combination therapy.

What is the FDA regulatory status of Proloprim?

Proloprim was approved through a New Drug Application identified in FDA records as NDA 017573. The original approval dates to the early U.S. commercial history of trimethoprim, and the product has long since moved from an innovative-product market into a genericized market.[2]

FDA regulatory status must be separated into three categories:

1. The active ingredient, trimethoprim, remains an established FDA-recognized antibacterial.
2. The original Proloprim brand does not have meaningful new-drug exclusivity.
3. Marketing status may vary by specific labeler, package, and National Drug Code.

FDA’s “Discontinued Drug Product List” does not mean that an active ingredient is withdrawn for safety or efficacy reasons. A product may appear as discontinued because a manufacturer stopped commercial distribution, changed its product portfolio, or replaced one NDC with another.[3]

The practical commercial result is that FDA approval history supports continued generic availability of trimethoprim, while it does not create a durable growth platform for the Proloprim brand.

What patents protect Proloprim and when did exclusivity expire?

No active Proloprim patent estate is expected to constrain generic entry in the United States. The relevant composition-of-matter and original product rights expired decades ago, before the current generic market structure developed.

The Orange Book is the controlling source for listed patents and regulatory exclusivity associated with approved drug products. For an old trimethoprim product such as Proloprim, the commercially relevant conclusion is that:

• Original product protection has expired.
• No meaningful remaining market exclusivity prevents ANDA approvals.
• Any residual product-specific patent listing would need to be assessed against the current Orange Book entry and applicable NDC.
• New patents on manufacturing, formulations, or combinations would not automatically restore exclusivity for ordinary trimethoprim tablets.[4]

Exclusivity category	Proloprim position
Original compound patent	Expired
Original product patent	Expired or commercially irrelevant
Pediatric exclusivity	No current commercial significance
Orphan exclusivity	None identified
New chemical entity exclusivity	Expired
Orange Book blocking position	No material blocking position expected
Generic substitution barrier	Low

The absence of a current patent moat is the main reason Proloprim cannot support premium branded pricing.

How many generic competitors challenge Proloprim?

Trimethoprim tablets have been available through generic approvals for many years. The competitive field has included multiple ANDA holders and labelers, although the number of active suppliers varies by strength, package size, manufacturing site, and period.

Generic competition affects Proloprim through automatic or pharmacist-driven substitution, formulary preference, wholesaler purchasing, and payer reimbursement. The product has few technical barriers:

• The active ingredient is a small molecule.
• The dosage form is an immediate-release tablet.
• No complex delivery system is required.
• Bioequivalence testing is comparatively straightforward.
• Manufacturing equipment is standard for solid oral dosage forms.

FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, is the principal source for identifying approved therapeutically equivalent products.[4] Because supplier counts change as companies enter, exit, or face manufacturing constraints, a fixed competitor count would not accurately describe the market over time.

What is the Orange Book status of Proloprim?

The Orange Book is relevant to Proloprim in two ways: it identifies the reference product and records therapeutic-equivalence information for generic versions. It also provides the framework for determining whether patents or exclusivity periods could delay generic approval.

For Proloprim, the commercial implications are straightforward:

• The product is an old reference drug.
• Generic trimethoprim products have been approved through ANDA pathways.
• There is no current branded exclusivity period comparable to those protecting recently approved drugs.
• A Paragraph IV challenge is not the principal market event because the important original rights expired long ago.

Generic applicants historically could use Paragraph IV certifications only when Orange Book-listed patents remained relevant. For Proloprim, ordinary generic entry has primarily depended on expiration of legacy rights and satisfaction of FDA quality and bioequivalence requirements, not on a modern patent litigation campaign.

What is the financial trajectory of Proloprim?

Proloprim’s financial trajectory is best characterized as a long-term decline in branded economics followed by stabilization at a low-margin generic level.

Revenue profile

No public company filings provide a dependable standalone Proloprim revenue series. Manufacturers typically report broad segments such as generic pharmaceuticals, specialty products, or branded prescription products. Proloprim revenue is therefore not separately visible in most annual reports or investor presentations.

The likely financial progression is:

Period	Commercial condition	Financial effect
Initial branded period	Limited competition and brand recognition	Higher price and stronger gross margin
Early generic period	ANDA approvals and substitution	Price erosion and lower share
Mature generic period	Multiple suppliers and payer pressure	Low price, low margin, high volume sensitivity
Current legacy period	Intermittent brand visibility and portfolio rationalization	Limited standalone revenue and strategic importance

Unit volume can remain stable while revenue declines because generic prices fall faster than prescription demand. The product may retain positive cash contribution if manufacturing costs are low, but that contribution is vulnerable to contract repricing, wholesaler fees, quality remediation, and supply interruptions.

Margin drivers

The principal factors affecting Proloprim profitability are:

• Active pharmaceutical ingredient cost for trimethoprim.
• Tablet manufacturing and packaging cost.
• Batch size and plant utilization.
• Number of active suppliers.
• Pharmacy benefit manager reimbursement.
• Wholesaler purchasing terms.
• Product discontinuations by competitors.
• Regulatory compliance and inspection costs.
• Inventory write-offs from low-volume package sizes.

A low-volume legacy product can be profitable when competition is limited. It can become uneconomic when several suppliers compete for the same contracts and the manufacturer must maintain dedicated regulatory, quality, and distribution infrastructure.

What market dynamics affect trimethoprim demand?

Demand is stable but structurally constrained. Proloprim operates in a therapeutic area where treatment decisions are influenced by antimicrobial resistance, local susceptibility data, guideline preferences, and availability of alternative antibiotics.

Trimethoprim competes with:

• Nitrofurantoin.
• Fosfomycin.
• Trimethoprim-sulfamethoxazole.
• Fluoroquinolones in selected circumstances.
• Certain beta-lactam antibiotics.

The principal demand risks are resistance and clinical substitution. The FDA label states that local susceptibility patterns should guide antibacterial selection.[1] Trimethoprim resistance can reduce use in uncomplicated urinary tract infections, particularly where resistance rates exceed accepted clinical thresholds.

The product also faces safety and tolerability constraints, including hyperkalemia risk, renal dosing considerations, folate-related adverse effects, and interaction concerns. These risks do not eliminate demand but can shift prescribing toward alternatives.

How does Proloprim compare with competing UTI antibiotics?

Product	Main differentiation	Patent position	Competitive pressure
Proloprim	Single-agent trimethoprim; established oral tablet	Expired	High
Generic trimethoprim-sulfamethoxazole	Broader historical use and combination activity	Expired	High
Nitrofurantoin	Common first-line UTI option	Expired for core products	High
Fosfomycin	Single-dose treatment option in selected cases	Product-specific and largely mature	Moderate to high
Fluoroquinolones	Broad activity but constrained by safety and stewardship concerns	Core rights expired	High

Proloprim’s main commercial disadvantage is that it lacks a strong present-day differentiator. A manufacturer cannot rely on novel pharmacology, a proprietary delivery system, or protected clinical data to defend pricing.

What formulation patents protect Proloprim?

No significant formulation patent strategy is associated with the conventional Proloprim immediate-release tablet. The product does not depend on a controlled-release platform, transdermal system, injectable device, or other complex drug-delivery technology.

This matters commercially because formulation complexity can create barriers even after compound-patent expiry. Proloprim lacks that protection. A generic manufacturer can compete with a conventional immediate-release tablet if it satisfies FDA requirements for identity, strength, quality, stability, labeling, and bioequivalence.

Any future formulation patent covering a modified trimethoprim product would protect only the claimed formulation and use. It would not prevent ordinary generic competition against an unmodified Proloprim tablet.

What manufacturing and intellectual-property barriers affect Proloprim?

Manufacturing barriers are limited but not zero. The active pharmaceutical ingredient is established, and oral tablet production is technically routine. The meaningful barriers are operational:

• FDA-compliant API sourcing.
• Supplier qualification.
• Content uniformity and dissolution control.
• Stability in the marketed package.
• Continuity of supply for low-volume strengths.
• Compliance with current good manufacturing practice requirements.
• Maintenance of an approved ANDA or NDA supplement history.

For a low-price product, fixed quality and regulatory costs can represent a substantial share of total economics. A manufacturer may leave the market even when demand remains because the net contribution does not justify ongoing compliance costs.

Which companies are challenging Proloprim?

The primary challengers are generic manufacturers rather than branded pharmaceutical innovators. ANDA applicants and labelers may change over time, and the active supplier list depends on FDA approval status and commercial availability.

No major current patent litigation campaign is associated with Proloprim. The market is driven by generic substitution and supplier competition, not by branded litigation over a remaining patent estate. Publicly disclosed licensing transactions specific to Proloprim are also not a material part of its commercial history.

Portfolio transfers and distribution arrangements may occur without being reported as product-specific licensing deals. Public filings generally do not isolate Proloprim economics or disclose detailed contract terms.

What generic launch scenarios exist for Proloprim?

The most likely commercial scenarios are:

Continued low-price availability

Multiple suppliers remain active, keeping prices low and limiting branded revenue. This is the base case for an established immediate-release antibiotic.

Supplier consolidation

One or more manufacturers exit because of low margins, quality costs, or API supply issues. Reduced competition can temporarily improve prices for remaining suppliers, but it can also increase shortage risk.

Brand discontinuation with generic persistence

The Proloprim name loses commercial visibility while generic trimethoprim remains available. This is the most likely long-term trajectory for an old branded product without exclusivity.

Temporary price volatility

A manufacturing disruption or shortage at one supplier can cause short-term price increases. Such pricing would reflect supply conditions rather than durable product strength.

What litigation and settlement risks affect Proloprim?

No material current Paragraph IV litigation or settlement structure is central to Proloprim’s market outlook. The product’s key patent barriers expired long ago, and modern commercial risk arises from ordinary generic competition.

The more relevant legal risks are:

• Product liability claims.
• Manufacturing and quality enforcement.
• Labeling compliance.
• Antitrust scrutiny of generic supply or pricing conduct.
• Contract disputes involving wholesalers or distributors.
• State substitution and reimbursement rules.

These risks can affect individual suppliers but do not create a coherent branded litigation opportunity.

What is the investment outlook for Proloprim?

Proloprim is unlikely to be a major revenue-growth asset. Its investment value, if any, would be tied to portfolio economics rather than innovation.

A buyer or licensee would evaluate:

• Net sales after rebates and discounts.
• Gross margin by strength and package.
• Number of active competitors.
• API cost and supply concentration.
• Historical shortage frequency.
• Manufacturing site compliance.
• Product discontinuation risk.
• Working-capital requirements.
• Cross-selling value within a generic portfolio.

The asset may appeal to a company with excess solid-dose capacity, established wholesaler relationships, or a portfolio strategy focused on legacy products. It is less attractive to a company seeking durable pricing power, patent protection, or significant top-line growth.

Key Takeaways

• Proloprim is the legacy trimethoprim brand for an established oral antibacterial.
• Its original patent and regulatory exclusivity have expired.
• Generic trimethoprim competition is the main commercial force.
• No material current Paragraph IV litigation or settlement structure drives the market.
• Product-level revenue is not publicly disclosed.
• The financial profile is mature, low-margin, and volume-sensitive.
• Formulation and manufacturing barriers are limited compared with complex drugs.
• Trimethoprim demand is constrained by resistance, clinical guidelines, and alternative UTI antibiotics.
• The most likely long-term outcome is continued generic availability with declining brand relevance.
• The product has portfolio value only where manufacturing and distribution costs are tightly controlled.

FAQs

Is Proloprim still available in the United States?

Trimethoprim remains available through generic products, while the availability of a specific Proloprim-branded NDC can vary by manufacturer and distribution channel. FDA status is product-specific.

Is Proloprim the same as Bactrim?

No. Proloprim contains trimethoprim alone. Bactrim contains trimethoprim and sulfamethoxazole. The products have different labels, dosing considerations, and antibacterial coverage.

Does Proloprim have pediatric exclusivity?

No current pediatric exclusivity has meaningful commercial effect for Proloprim. Any original exclusivity periods associated with the historical product have expired.

Can a generic manufacturer obtain FDA approval for trimethoprim without challenging a patent?

Yes. For an old product without blocking Orange Book-listed patents, an ANDA applicant can seek approval through the standard generic pathway, including the required bioequivalence and quality demonstrations.

Is Proloprim a viable pharmaceutical licensing target?

Only in a limited portfolio context. Its attractiveness depends on supply reliability, manufacturing cost, market concentration, and net contribution. It is not an attractive target based on patent protection or standalone growth prospects.

References

1. U.S. Food and Drug Administration. (n.d.). Proloprim (trimethoprim) tablets prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Proloprim, NDA 017573.
3. U.S. Food and Drug Administration. (n.d.). Discontinued drug product list.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.