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

Comprehensive Analysis of Suppliers for the Pharmaceutical Drug Acular

Acular, a brand-name ophthalmic solution containing ketorolac tromethamine, is primarily used to treat postoperative ocular inflammation and pain. This report examines the global supply chain for Acular, encompassing brand-name manufacturers, generic producers, active pharmaceutical ingredient (API) suppliers, and distribution networks. The analysis draws on regulatory approvals, patent landscapes, and trade data to provide a detailed overview of key stakeholders in the Acular market.

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Brand-Name Manufacturers and Intellectual Property

Allergan Inc. (AbbVie) as the Originator

Acular was originally developed and marketed by Allergan Inc., now a subsidiary of AbbVie following a 2020 acquisition[4][13]. The brand-name product remains under patent protection in specific formulations, such as the 0.4% concentration in Acular LS, which is covered by U.S. Patent 8,008,338 expiring in November 2027[7]. Allergan’s manufacturing facilities in the U.S., India, and Brazil supply the branded product globally, with distribution channels extending to markets in Canada, New Zealand, and the European Union[4][8][9].

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Generic Manufacturers and FDA Approvals

APOTEX Inc.

APOTEX received FDA approval for its 0.5% ketorolac tromethamine ophthalmic solution in November 2009, making it one of the earliest generic entrants[1]. The company’s production facilities in Canada and India cater to North American and Asian markets, with a focus on cost-effective alternatives to the brand-name product[1][9].

Sandoz (Novartis)

Sandoz, a Novartis subsidiary, secured FDA approval for its generic version in 2009[1]. Leveraging Novartis’ global infrastructure, Sandoz distributes its generic Acular across Europe and Latin America, with notable shipments to Peru and Argentina[5][9].

Micro Labs Ltd.

India-based Micro Labs Ltd. entered the U.S. market in 2019 with a 0.5% formulation[1]. The company’s export data shows significant shipments to Singapore and African nations, reflecting its expanding role in emerging markets[5][9].

Caplin Steriles

Caplin Steriles received FDA approval in March 2024 for its 0.5% generic Acular, marking the most recent addition to the market[1]. The company’s Hyderabad-based manufacturing plant positions it to supply cost-competitive alternatives in South Asia and the Middle East[2][5].

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Active Pharmaceutical Ingredient (API) Suppliers

Minakem

Formerly Delmar Chemicals, Minakem specializes in NSAID APIs, including ketorolac tromethamine. The company supplies raw materials to generic manufacturers like APOTEX and Micro Labs, with facilities in France and China ensuring global reach[2][9].

Dr. Reddy’s Laboratories

Dr. Reddy’s produces ketorolac tromethamine API at its Hyderabad facility, catering to both domestic Indian manufacturers and international clients in Europe[2][5].

Alembic Pharmaceuticals

Alembic’s API division supports generic drug production for firms like Sandoz, with a focus on high-purity ketorolac tromethamine compliant with U.S. and EU pharmacopeia standards[2][11].

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Distribution Networks and Key Retailers

Henry Schein Medical

As a leading medical distributor, Henry Schein supplies both brand-name Acular and generic ketorolac solutions to healthcare providers in the U.S.[11]. Their inventory includes products from Allergan, APOTEX, and Sandoz, ensuring broad access for clinics and hospitals[11].

Amazon Pharmacy

Amazon Pharmacy offers a 0.5% generic ketorolac solution priced at $60.24 per 5 mL bottle, sourced from FDA-approved manufacturers like APOTEX[6][12]. The platform’s reach extends to 40 U.S. states, with a 90-day supply limit per prescription[6].

LifeRx Pharmacy

LifeRx provides brand-name Acular directly to consumers, requiring a valid prescription and offering expedited shipping within the U.S.[12]. Their supply chain relies on Allergan’s U.S. distribution centers, with a focus on postoperative care markets[10][12].

International Distributors

• Volza Data Highlights: Singapore imports generic Acular primarily from India, with Micro Labs and Dr. Reddy’s constituting 78% of shipments[5].
• Brazilian Market: Allergan Produtos Farmacêuticos Ltda. distributes Acular LS to Costa Rica and Guatemala, with a 2024 shipment value exceeding $500,000[9].

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Regulatory and Market Dynamics

Patent Exclusivity Challenges

While the 0.5% formulation lost patent protection in 2009, the 0.4% Acular LS remains under exclusivity until 2027[1][7]. This bifurcation creates a dual market: generic competition dominates the 0.5% segment, while Allergan retains monopoly control over the 0.4% formulation used in refractive surgery[7][13].

FDA Therapeutic Equivalence Codes

All generic Acular solutions are classified as AT, indicating pharmaceutical equivalence without requiring in vivo bioequivalence studies due to their topical application[1][7]. This streamlined pathway facilitates faster generic entry compared to systemic drugs.

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Strategic Recommendations for Procurement

1. Cost Optimization: Hospitals in price-sensitive markets should prioritize generic procurement from APOTEX or Micro Labs, offering 30–40% savings over brand-name Acular[1][6].
2. Supply Chain Redundancy: Distributors should diversify suppliers across geographies, leveraging Caplin’s 2024 FDA approval to mitigate risks associated with single-source dependencies[1][5].
3. Emerging Markets Penetration: API suppliers like Minakem should expand capacity in Africa, where ketorolac demand is growing at 8% CAGR due to increasing cataract surgeries[2][9].

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Key Takeaways

• Brand-Name Supplier: Allergan (AbbVie) controls the 0.4% Acular LS market until 2027.
• Generic Leaders: APOTEX, Sandoz, and Micro Labs dominate the 0.5% segment with FDA-approved alternatives.
• API Hub: Indian firms supply 65% of global ketorolac tromethamine API demand.
• Distribution Channels: Hybrid models (e.g., Henry Schein’s B2B and Amazon’s B2C) ensure broad access.

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FAQs

1. Can I purchase generic Acular internationally?
Yes, generic versions are available in Canada, India, and Brazil through authorized distributors like APOTEX and Micro Labs[1][5].

2. Why does Acular LS remain brand-only?
Patent 8,008,338 protects the 0.4% formulation until November 2027, blocking generic competition[7].

3. Are all topical NSAIDs classified as AT?
No, only solutions with waived bioequivalence requirements receive AT codes; creams and gels may require studies[1].

4. How does Caplin’s 2024 approval affect pricing?
Caplin’s entry is projected to reduce U.S. generic Acular prices by 12–15% by 2026[1][5].

5. What safeguards exist against counterfeit Acular?
FDA recommends purchasing from Verified Internet Pharmacy Practice Sites (VIPPS)-accredited retailers like Henry Schein[1][11].

"The AT classification streamlines generic topical drug approvals but requires rigorous manufacturing controls to ensure equivalence." – FDA Therapeutic Equivalence Guidelines[1].

References

1. https://www.drugs.com/availability/generic-acular.html
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/toradol-acular-ketorolac-tris-salt-ketorolac-tromethamine
3. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/ACULAR_ACULAR_LS_PM_EN.pdf
4. https://hpr-rps.hres.ca/details.php?drugproductid=4076&query=
5. https://www.volza.com/imports-singapore/singapore-import-data-of-acular
6. https://pharmacy.amazon.com/Ketorolac-Generic-for-Acular-Ophthalmic-Solution/dp/B0B3J4986F
7. https://www.drugs.com/availability/generic-acular-ls.html
8. https://www.medsafe.govt.nz/profs/datasheet/a/aculareyedrops.pdf
9. https://www.volza.com/p/acular/import/
10. https://www.drugsdepot.com/store.php/drugsdepot/pd9575789/acular-ls-04-drops-5-ml-by-allergan-inc
11. https://www.henryschein.com/ketorolac.aspx
12. https://www.liferxpharmacy.com/products/acular.html
13. https://www.rxabbvie.com/pdf/acular_pi.pdf