Suppliers and packagers for BROVANA

BROVANA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-055-30	30 POUCH in 1 CARTON (27437-055-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (27437-055-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2023-10-01
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-055-60	15 POUCH in 1 CARTON (27437-055-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (27437-055-04) / 2 mL in 1 VIAL, SINGLE-DOSE	2023-10-01
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-060-30	30 POUCH in 1 CARTON (27437-060-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE	2024-04-15

Brovana (Arformoterol Tartrate) Supplier Landscape and Market Dynamics

Brovana (arformoterol tartrate) is a long-acting beta2-adrenergic agonist (LABA) approved by the U.S. Food and Drug Administration (FDA) in 2006 for the maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD)[3][4]. Initially developed by Sepracor Inc. (later acquired by Sunovion Pharmaceuticals), Brovana has undergone significant shifts in its supply chain and market presence since the expiration of its patent exclusivity. This report examines the current supplier ecosystem, regulatory milestones, and competitive dynamics shaping Brovana’s availability.

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Historical Development and Original Manufacturer

FDA Approval and Early Market Presence

Brovana received FDA approval on October 6, 2006, as a nebulized solution for COPD management[3]. Sunovion Pharmaceuticals, a U.S. subsidiary of Sumitomo Pharma, commercialized the drug, leveraging its novel mechanism as a twice-daily bronchodilator[4]. The drug’s initial patent protections granted Sunovion exclusivity, but the eventual expiry of these rights precipitated the entry of generic competitors[1].

Strategic Divestiture to Lupin

In October 2022, Sunovion divested U.S. rights to Brovana and Xopenex HFA to Lupin Limited for $75 million, marking a pivotal shift in the drug’s supply chain[2][9][12]. This transaction enabled Lupin to expand its respiratory portfolio, which already included an authorized generic version of Brovana launched in June 2021[7][8]. The acquisition aligned with Lupin’s strategy to strengthen its position in the U.S. inhalation therapy market[10][12].

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Generic Supplier Ecosystem

Authorized Generics and First-wave Entrants

Lupin’s authorized generic version, introduced in 2021, was the first to market, closely followed by competitors such as Cipla, Dr. Reddy’s, and Teva[1][5][6]. Authorized generics are bioequivalent to the brand-name drug and typically enter the market immediately after patent expiry, often through agreements with the original manufacturer[1][7]. Cipla’s FDA approval in June 2021 marked a significant milestone, with the company noting Brovana’s annual market value at $438 million prior to genericization[5][6].

Expansion of Generic Manufacturers

By 2025, the FDA had approved over a dozen generic arformoterol tartrate suppliers, including:

• Alembic Pharmaceuticals (May 2022)[1]
• Auctor Pharma (February 2025)[1]
• Micro Labs (March 2025)[1]
• Cipla (June 2021)[6]
• Teva Pharmaceuticals (November 2021)[1]

These suppliers operate under the FDA’s Abbreviated New Drug Application (ANDA) pathway, demonstrating therapeutic equivalence to the reference-listed drug (RLD)[1][4]. The AN rating assigned to Brovana generics indicates pharmaceutical equivalence, with nebulized solutions deemed interchangeable regardless of delivery systems[1].

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Active Pharmaceutical Ingredient (API) Suppliers

Key API Manufacturers

The production of arformoterol tartrate API involves specialized manufacturers, primarily based in India and China:

• Inke S.A. (Spain): Focuses on complex API synthesis for inhalation products[11][13].
• Harman Finochem (India): Produces over 45 APIs, including arformoterol tartrate, under WHO-GMP standards[11][13].
• Cipla (India): Vertically integrated, supplying API for its own generic formulations[6][11].
• MSN Laboratories (India): Known for high-volume API production with USDMF compliance[11][13].

Regulatory Compliance and Quality Assurance

API suppliers must adhere to Good Manufacturing Practices (GMP) and submit Drug Master Files (DMFs) to regulatory agencies. For instance, Inke S.A. maintains a U.S. DMF (USDMF) for arformoterol tartrate, ensuring compliance with FDA standards[11][13]. Counterfeit risks, as noted by Drugs.com, underscore the importance of sourcing APIs from certified suppliers[1][13].

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Market Impact and Competitive Dynamics

Price Erosion and Accessibility

The entry of generics has driven significant price reductions. Lupin’s authorized generic, launched in 2021, provided immediate cost savings, while subsequent approvals from Auctor, Micro Labs, and others intensified competition[1][7][8]. By 2025, the U.S. market featured over 15 interchangeable generic versions, enhancing patient access to affordable COPD therapies[1].

Strategic Acquisitions and Portfolio Expansion

Lupin’s 2022 acquisition of Brovana and Xopenex HFA from Sunovion exemplifies consolidation trends in the respiratory sector[2][9][12]. This move not only solidified Lupin’s market share but also enabled cross-promotion with its albuterol MDI, creating a comprehensive COPD treatment portfolio[9][12].

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Regulatory and Supply Chain Challenges

Patent Exclusivity and Litigation Risks

Brovana’s original patents expired by 2021, allowing unrestricted generic entry. However, litigation risks persist, particularly regarding formulation patents or delivery-system innovations[1][4]. For example, nebulized solutions compatible with specific devices (e.g., PARI LC Sprint nebulizers) may involve secondary patents[4].

Counterfeit Mitigation Strategies

Fraudulent online pharmacies pose risks to supply chain integrity. The FDA and manufacturers like Cipla emphasize verification through reputable pharmacies and distributor partnerships[1][6]. Lupin’s authorized generic program includes tamper-evident packaging and track-and-trace technologies to combat counterfeiting[7][8].

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Future Outlook and Emerging Trends

Biologics and Next-generation Inhalers

While Brovana generics dominate the LABA segment, emerging biologic therapies (e.g., monoclonal antibodies for eosinophilic COPD) could reshape treatment paradigms. Suppliers like Lupin are investing in dry-powder inhalers (DPIs) to compete with nebulized formulations[9][12].

Global Expansion Opportunities

India-based API manufacturers, including Glenmark and Hetero Labs, are expanding into emerging markets in Asia and Africa[11][13]. Cipla’s focus on affordable COPD therapies aligns with WHO initiatives to reduce global burden[6][11].

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Conclusion

The Brovana supplier ecosystem is characterized by robust competition among generic manufacturers, stringent regulatory oversight, and strategic acquisitions. Lupin’s dominance in the authorized generic segment, coupled with API diversification from firms like Inke S.A. and Harman Finochem, ensures stable supply chains. However, challenges such as counterfeit products and biologic disruptors necessitate ongoing innovation. As the COPD market evolves, suppliers must balance cost efficiency with investments in next-generation delivery systems and global accessibility initiatives.

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Key Takeaways

1. Brovana’s patent expiry in 2021 catalyzed the entry of over 15 generic suppliers, reducing costs by up to 80%.
2. Lupin’s acquisition of Brovana rights in 2022 solidified its leadership in the U.S. respiratory market.
3. API suppliers like Inke S.A. and Cipla adhere to USDMF and WHO-GMP standards to ensure quality.
4. Counterfeit risks necessitate stringent supply chain controls and patient education.
5. Emerging biologic therapies and inhaler technologies may challenge traditional LABA formulations.

FAQs

1. What is the difference between authorized generics and other Brovana generics?
   Authorized generics are identical to the brand-name drug and typically launch first, while other generics require separate FDA approvals[1][7].

2. How do I verify a legitimate Brovana supplier?
   Purchase from FDA-approved pharmacies or use verification tools like the FDA’s BeSafeRx campaign[1].

3. Which companies supply arformoterol tartrate API?
   Leading suppliers include Inke S.A., Cipla, and Harman Finochem, all compliant with GMP standards[11][13].

4. Has Lupin discontinued the Brovana brand?
   No, Lupin markets both the authorized generic and brand-name versions post-acquisition[9][12].

5. Are Brovana generics effective for severe COPD?
   Yes, FDA-approved generics are therapeutically equivalent to the original drug[1][4].

"The rapid entry of generics has transformed COPD care, making lifesaving therapies accessible to millions." – Industry Analyst [5][6].

References

1. https://www.drugs.com/availability/generic-brovana.html
2. https://www.sumitomo-pharma.com/news/20221020.html
3. https://www.drugs.com/history/brovana.html
4. https://fda.report/NDC/63402-911
5. https://drugstorenews.com/fda-clears-ciplas-generic-brovana
6. https://www.cipla.com/press-releases-statements/cipla-receives-usfda-approval-generic-version-Sunovion-Pharmaceuticals-Brovana-Arformoterol-Tartrate-Inhalation-Solution
7. https://www.lupin.com/lupin-launches-authorized-generic-version-of-brovana-in-the-united-states/
8. https://copdnewstoday.com/news/fda-approves-lupin-generic-version-brovana-bronchoconstriction-long-term-copd-treatment/
9. https://www.lupin.com/lupin-signs-agreement-to-acquire-two-inhalation-brands-from-sunovion/
10. https://economictimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-inks-pact-to-acquire-two-inhalation-brands-from-sunovion-for-usd-75-mn/articleshow/94979356.cms
11. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/brovana
12. https://www.bwhealthcareworld.com/article/lupin-acquires-two-inhalation-brands-from-sunovion-for-75-mn-451393
13. https://www.pharmacompass.com/active-pharmaceutical-ingredients/brovana
14. https://www.och.org/och-one-of-two-hospitals-in-southeast-chosen-for-pharmaceutical-pilot-program/