Suppliers and packagers for LOTEPREDNOL ETABONATE

LOTEPREDNOL ETABONATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sentiss	LOTEPREDNOL ETABONATE	loteprednol etabonate	GEL;OPHTHALMIC	212080	ANDA	Sentiss Pharmaceuticals LLC	70244-036-01	1 BOTTLE, DROPPER in 1 CARTON (70244-036-01) / 5 g in 1 BOTTLE, DROPPER	2026-04-17
Sentiss	LOTEPREDNOL ETABONATE	loteprednol etabonate	GEL;OPHTHALMIC	212080	ANDA	ARMAS PHARMACEUTICALS INC.	72485-630-05	1 BOTTLE, DROPPER in 1 CARTON (72485-630-05) / 5 g in 1 BOTTLE, DROPPER	2023-10-25
Amneal	LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	216345	ANDA	Amneal Pharmaceuticals NY LLC	60219-1366-3	1 BOTTLE in 1 CARTON (60219-1366-3) / 5 mL in 1 BOTTLE	2024-12-18
Amneal	LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	216345	ANDA	Amneal Pharmaceuticals NY LLC	60219-1367-6	1 BOTTLE in 1 CARTON (60219-1367-6) / 10 mL in 1 BOTTLE	2024-12-18
Amneal	LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	217484	ANDA	Amneal Pharmaceuticals NY LLC	60219-1362-1	1 BOTTLE in 1 CARTON (60219-1362-1) / 5 mL in 1 BOTTLE	2025-05-22
Amneal	LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	217484	ANDA	Amneal Pharmaceuticals NY LLC	60219-1362-2	1 BOTTLE in 1 CARTON (60219-1362-2) / 10 mL in 1 BOTTLE	2025-05-22
Amneal	LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	217484	ANDA	Amneal Pharmaceuticals NY LLC	60219-1362-3	1 BOTTLE in 1 CARTON (60219-1362-3) / 15 mL in 1 BOTTLE	2025-05-22

Suppliers for the Pharmaceutical Drug: Loteprednol Etabonate

Last updated: February 20, 2026

Who Are the Top Manufacturers of Loteprednol Etabonate?

Loteprednol etabonate is a corticosteroid used primarily for allergic conjunctivitis, postoperative inflammation, and other ocular inflammations. Multiple pharmaceutical companies produce this compound, often through licensing agreements and generic manufacturing.

Main Market Players

Company	Country	Production Capacity	Drug Forms	Notable Markets
Bausch + Lomb	USA	High	Ophthalmic suspension and gel	North America, Europe
Sun Pharmaceutical	India	Moderate	Ophthalmic suspension	Asia, emerging markets
Sandoz (Novartis)	Switzerland	High	Ophthalmic suspension	Global
Amneal Pharmaceuticals	USA	Moderate	Ophthalmic suspension	US, Canada
TEVA Pharmaceuticals	Israel	High	Ophthalmic suspension	Global

Licensing and Patent Status

• Patent Expiry: The original patent expired around 2003 in the U.S. [1].
• Generic Availability: Numerous generics produced globally; Sandoz, Teva, and Amneal dominate the market.
• Licensing Agreements: Some companies, like Bausch + Lomb, originally developed proprietary formulations, whereas others acquire licenses from patent holders.

Regulatory Approvals

• Approved by the U.S. Food and Drug Administration (FDA) since 2003.
• Approved in the European Medicines Agency (EMA) jurisdictions.
• Other regulators in Asia and Latin America have approved generic versions under local regulations.

Production and Supply Chain Considerations

• Key manufacturing facilities are based in the U.S., India, and Europe.
• Supply constraints may arise from formulation complexity and raw material sourcing.
• Regulatory compliance (GMP standards) is critical; most suppliers adhere to internationally recognized GMP standards.

Market Dynamics

• Growing prevalence of ocular inflammatory conditions drives demand.
• Patent expiration led to increased entry of generics.
• Supply chain disruptions can impact availability, especially during the COVID-19 pandemic.

Summary

Multiple pharmaceutical companies manufacture loteprednol etabonate, mainly through generic formulations. Leading suppliers include Bausch + Lomb, Sun Pharma, Sandoz, Amneal, and Teva. The active pharmaceutical ingredient (API) is produced mainly in the U.S., India, and Europe, with globally distributed finished products. The market is characterized by increased generic competition following patent expiry and consistent regulatory oversight.

Key Takeaways

• The patent for loteprednol etabonate expired around 2003, increasing generic production.
• Top suppliers are Bausch + Lomb, Sandoz, Teva, Sun Pharma, and Amneal.
• Market growth is driven by rising ocular inflammation cases; supply chain stability depends on manufacturing compliance.
• The drug is approved in major regions, with generics available worldwide.
• Supply constraints can affect pricing and availability, especially in emerging markets.

FAQs

1. When did patent protection for loteprednol etabonate expire?
Patent protection expired around 2003 in the United States.[1]

2. Who currently supplies generics of loteprednol etabonate?
Sandoz, Teva, Amneal, and others manufacture generic versions globally.

3. What formulations of the drug are available?
Primarily ophthalmic suspension and gel.

4. Are there regional differences in supplier availability?
Yes; while global brands are available worldwide, regional distribution varies based on regulatory approvals and manufacturing licenses.

5. What factors influence the supply chain stability for loteprednol etabonate?
Regulatory compliance, raw material sourcing, production capacity, and manufacturing disruptions.

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References

[1] U.S. Patent and Trademark Office. (2003). Patent expiration date for loteprednol etabonate.