Suppliers and packagers for ACULAR

ACULAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700	NDA	Allergan, Inc.	0023-2181-05	1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER	1992-12-01

Suppliers for the Pharmaceutical Drug: ACULAR

Last updated: July 29, 2025

Introduction

ACULAR, a popular ophthalmic medication containing ketorolac tromethamine, is primarily used for the treatment of postoperative ocular inflammation and pain. As a non-steroidal anti-inflammatory drug (NSAID), ACULAR has garnered widespread clinical use due to its efficacy and safety profile. Its production and supply chain involve multiple pharmaceutical manufacturers and authorized distributors globally. This analysis provides a comprehensive overview of the primary suppliers of ACULAR, examining manufacturing entities, licensing arrangements, market dynamics, and regulatory considerations.

Pharmaceutical Manufacturers of ACULAR

The original formulation of ACULAR was developed and marketed by Allergan, now a subsidiary of AbbVie Inc. The drug was first approved in the United States in 1990 and has since become a key product within ophthalmic NSAIDs. Over the years, multiple generic manufacturers have entered the market following patent expirations, expanding the supply landscape.

Originator Manufacturer: AbbVie (formerly Allergan)

AbbVie, through its predecessor Allergan, held the original patent and marketed ACULAR until patent expiry, after which generic competition emerged. Allergan's role included not only manufacturing but also distribution agreements, establishing global supply chains for the drug.

Generic Manufacturers

Post-patent expiration, generic companies have become the primary suppliers of ketorolac tromethamine ophthalmic solutions. Generic manufacturers ensure broader availability and often at reduced costs, increasing access for healthcare providers and patients.

Key generic suppliers include:

• Sandoz (Novartis): Sandoz produces a ketorolac ophthalmic solution marketed in various regions, leveraging its robust global manufacturing network.

• Sun Pharmaceutical Industries: As a leading generic manufacturer, Sun Pharma supplies ketorolac-based eye drops in multiple markets, including India and parts of Europe.

• Akorn: Known for ophthalmic pharmaceuticals, Akorn manufactures ketorolac solutions that serve both prescription medication needs and compounding pharmacies.

• Bausch + Lomb: While primarily known for its own ophthalmology products, Bausch + Lomb also supplies generic ophthalmic NSAIDs that include ketorolac formulations.

• Aurobindo Pharma: A key Indian pharmaceutical exporter, Aurobindo offers ketorolac ophthalmic solutions approved in multiple jurisdictions.

• MediGene and other regional generics companies: These firms have also entered the market, especially in emerging markets.

Authorized and Contract Manufacturing

Due to the complexity of ophthalmic solution production, some suppliers operate via contract manufacturing organizations (CMOs). Contract manufacturing enables the original or licensed generic companies to meet demand, especially for large-volume markets.

Market Dynamics and Supply Chain Considerations

The supply of ACULAR hinges on both regulatory approvals and manufacturing capacity. Since the patent expiry, global supply has increased significantly, driven by the demand for affordable ophthalmic NSAIDs.

• Regulatory Approvals: Pharmaceutical companies must secure approvals from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and corresponding national bodies, influencing supply flow.

• Manufacturing Capacity: With multiple players, market stability depends on their capacity to meet prescription demand without shortages or quality issues. Recent shortages in ophthalmic NSAIDs, including ketorolac, have highlighted the importance of supply chain robustness.

• Pricing and Market Competition: Increased generic competition has driven prices down, improving patient access but exerting pressure on manufacturers' profit margins, potentially affecting supply decisions.

• Regional Variations: The availability of ACULAR and its generics varies globally, shaped by regional regulatory approvals, market size, and distribution logistics.

Regulatory and Patent Landscape

In major markets like the U.S., ACULAR's patent protections expired around 2014, paving the way for generics. Patent cliffs often lead to increased suppliers, intensifying competition, and improving supply consistency. However, product-specific patent protections or formulations can restrict generic entry in certain jurisdictions.

Emerging Trends and Future Outlook

• Biosimilars and Alternatives: Although biosimilars are more common in biologics, ongoing research aims to develop alternative ophthalmic NSAIDs that could supplement or compete with ketorolac-based products.

• Supply Chain Resilience: The COVID-19 pandemic underscored the importance of diversified supplier bases and resilient manufacturing strategies, which are now prioritized in the ophthalmic pharmaceuticals sector.

• Intellectual Property and Market Exclusivities: Strategic patent filings and patent term extensions can influence the timing of generic entry and subsequent supply availability.

Conclusion

The supply of ACULAR is characterized by a dual landscape: the original manufacturer AbbVie (formerly Allergan) and a growing pool of generic pharmaceutical companies. Key suppliers include Novartis/Sandoz, Sun Pharma, Akorn, Bausch + Lomb, and Aurobindo Pharma, among others. The expansion of generic manufacturing post-patent expiration has enhanced global availability, reduced costs, and mitigated shortages. Nonetheless, manufacturing capacity, regulatory hurdles, and regional market dynamics continue to shape the supply environment.

Key Takeaways

• Dominant Players: AbbVie remains the originator, with multiple generic manufacturers including Sandoz, Sun Pharma, Akorn, and Aurobindo Pharma supplying ACULAR globally.

• Patent Expiry Benefits: Post-patent expiration, increased generic competition has improved supply stability and lowered prices.

• Supply Chain Resilience: Manufacturers are adopting diversified sourcing and contract manufacturing to prevent shortages, especially amidst global disruptions.

• Regulatory Landscape Impact: Approvals and regional regulations significantly influence the timing and scope of ACULAR's supply.

• Future Outlook: Market expansion, potential biosimilar products, and emphasizing supply chain resilience will continue to shape the landscape for ACULAR suppliers.

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FAQs

1. Who are the leading suppliers of ACULAR worldwide?
Major suppliers include AbbVie (original manufacturer), Sandoz (Novartis), Sun Pharma, Akorn, Bausch + Lomb, and Aurobindo Pharma, offering both brand-name and generic ketorolac ophthalmic solutions.

2. How has patent expiration affected the availability of ACULAR?
Patent expiration around 2014 facilitated the entry of multiple generics, increasing supply, competition, and reducing costs for consumers across global markets.

3. What are the regulatory considerations impacting suppliers of ACULAR?
Manufacturers must obtain approvals from relevant agencies like the FDA and EMA. Regulatory hurdles can influence the timing and distribution scope of the drug.

4. Are there regional variations in ACULAR supply?
Yes, distribution depends on regional approvals, local manufacturing capacity, and market demand, leading to variable availability across countries.

5. What is the future outlook for ACULAR suppliers?
The market expects continued growth in generic manufacturing, enhanced supply chain resilience, and potential development of alternative ophthalmic NSAIDs, maintaining steady supply and competition.

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References

1. FDA Drug Approvals and Patent Information – U.S. Food and Drug Administration.
2. European Medicines Agency – Market Authorization Data.
3. Market analysis reports on ophthalmic pharmaceuticals and NSAIDs.
4. Press releases and annual reports from AbbVie, Sandoz, Sun Pharma, Akorn, and Bausch + Lomb.
5. Industry news on ophthalmic drug manufacturing trends and supply chain resilience strategies.