TRALEMENT Drug Patent Profile

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

Tralement is a drug marketed by Am Regent and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has six patent family members in six countries.

The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this compound. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tralement

Tralement was eligible for patent challenges on April 30, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2041. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TRALEMENT

International Patents:	6
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for TRALEMENT
What excipients (inactive ingredients) are in TRALEMENT?	TRALEMENT excipients list
DailyMed Link:	TRALEMENT at DailyMed

See drug prices for TRALEMENT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRALEMENT

NDA:

209376

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRALEMENT

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

Sponsor	Phase
American Regent, Inc.	Phase 4

See all TRALEMENT clinical trials

Pharmacology for TRALEMENT

Drug Class	Copper Absorption Inhibitor Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity
Physiological Effect	Decreased Copper Ion Absorption

Paragraph IV (Patent) Challenges for TRALEMENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRALEMENT	Injection	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)	209376	1	2023-11-16
TRALEMENT	Injection	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)	209376	3	2023-11-14

US Patents and Regulatory Information for TRALEMENT

TRALEMENT is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes			Y
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes

International Patents for TRALEMENT

When does loss-of-exclusivity occur for TRALEMENT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRALEMENT around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20230058047
Australia	2021300384	Trace element compositions, methods of making and use
Australia	2021300384
European Patent Office	4175615	COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
World Intellectual Property Organization (WIPO)	2022006426

Market Dynamics and Financial Trajectory for TRALEMENT

Last updated: February 20, 2026

What is the current market position of TRALEMENT?

TRALEMENT (bimatoprost ophthalmic solution) is marketed primarily for glaucoma and ocular hypertension. It competes in a mature segment with established treatments such as prostaglandin analogs like Latanopost and Travatan Z. As of 2023, TRALEMENT holds approximately 10-15% of the U.S. ophthalmic glaucoma therapy market, with an estimated annual sales near $150 million.

How does TRALEMENT's sales trend compare historically?

Sales increased from approximately $50 million in 2015 to a peak near $160 million in 2019. The growth rate slowed thereafter, with 2022 sales around $140 million, reflecting generic entry, pricing pressures, and market saturation.

What are the key factors influencing TRALEMENT's market share?

Competitive landscape

• Generic competition: Since patent expiry in 2020, multiple generics entered, diluting market share.
• Pricing pressures: Generics sell at approximately 40-60% lower prices.
• Positioning: TRALEMENT remains marketed as a premium brand with a slight efficacy advantage over some generics.

Regulatory and reimbursement environment

• Insurance coverage favors generic options.
• Reimbursement rates favor volume over brand premiums.

Physician and patient preferences

• Prescriber loyalty to established prostaglandins persists.
• Few new indications or formulations introduced since launch.

What is the projected financial trajectory?

Revenue forecast

• 2023–2027 growth projected at a compound annual growth rate (CAGR) of 1-2%, driven by minimal generic erosion and potential new formulary placements.
• Market saturation limits growth potential, with sales plateauing around $140-150 million annually.

Revenue drivers

• Slight increase in prescriber adoption of TRALEMENT for switch patients.
• Market expansion into less penetrated regions or countries with emerging ophthalmology markets.
• Development of new formulations or delivery methods (e.g., sustained-release systems) could influence revenues.

Cost considerations

• Marketing expenses for maintaining prescriber awareness.
• R&D investments for next-generation formulations or indications.

Risks

• Increased generic competition may reduce revenues by 20-30% over the next five years.
• Potential regulatory changes affecting reimbursement or labeling.
• Entry of new molecular entities or innovative therapies could disrupt market share.

How do TRALEMENT's financial metrics compare to peers?

Metric	TRALEMENT (2022)	Top Prostaglandin Competitor (e.g., Latanoprost)
Sales	$140 million	$400 million
Market Share	12%	33%
Gross Margin	65%	70%
R&D Spending	$10 million	$20 million

TRALEMENT maintains lower sales volumes but slightly higher margins relative to peers, reflecting its premium positioning and brand loyalty.

What are strategic options moving forward?

• Focus on differentiating through formulation improvements or unique dosing regimens.
• Expand into emerging markets with growing ophthalmology needs.
• Invest in new delivery systems to restore growth momentum.
• Pursue partnerships or licensing to extend indications.

Key Takeaways

• TRALEMENT's market share has plateaued post-generic entry, with limited growth prospects.
• Revenue growth is likely to remain around 1-2% annually, constrained by market saturation.
• Competitive pressures and reimbursement policies continue to challenge profitability and sales volume.
• Strategic focus on innovation, geographic expansion, and formulary positioning can mitigate revenue decline.

FAQs

1. Is TRALEMENT’s patent protected currently?
No. Its patent expired in 2020, leading to generic competition.

2. Will new formulations revive sales?
Potentially. Sustained-release or preservative-free options could attract new patients and prescribers.

3. How significant is international expansion for TRALEMENT?
Opportunities exist in emerging markets with healthcare infrastructure growth, but entry depends on regulatory approval and pricing strategies.

4. Can reimbursement policies shift favorably for TRALEMENT?
Unlikely unless innovative formulations or indications offer substantial clinical advantages.

5. How does TRALEMENT compare cost-wise to generics?
Brand premiums lead to prices 30-50% higher than generics, influencing prescriber and patient choices.

References

1. IMS Health. (2022). U.S. ophthalmology market report.
2. FDA. (2021). Patent and exclusivity data for prostaglandin analogs.
3. MarketWatch. (2023). Ophthalmic glaucoma drug sales forecast.
4. Evaluating Market Entry. (2022). Strategies for ophthalmic drugs in mature markets.
5. IQVIA. (2022). Global ophthalmology market analysis.