LEVALBUTEROL TARTRATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2927-54	1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER	2016-10-03
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA	Lupin Pharmaceuticals, Inc.	27437-056-01	1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER	2023-11-10
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA AUTHORIZED GENERIC	Praxis, LLC	59368-410-01	1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER	2016-10-03
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA AUTHORIZED GENERIC	Proficient Rx LP	63187-876-15	1 INHALER in 1 CARTON (63187-876-15) / 200 AEROSOL, METERED in 1 INHALER	2016-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies primary suppliers of levalbuterol tartrate and analyzes the patent landscape impacting its market availability. Key manufacturers include Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Cipla Ltd. The patent expiration for Xopenex HFA (levalbuterol tartrate inhalation aerosol) in the United States, originally scheduled for 2014, has been subject to multiple legal challenges and extensions, influencing generic market entry.

Key Suppliers of Levalbuterol Tartrate

The supply chain for levalbuterol tartrate involves both active pharmaceutical ingredient (API) manufacturers and finished dosage form producers. Dominant players include global pharmaceutical companies with established generics divisions and specialized API suppliers.

Major API and Finished Dosage Form Suppliers:

Sun Pharmaceutical Industries Ltd.: This Indian multinational pharmaceutical company is a significant player in the generics market. Sun Pharma manufactures and markets a levalbuterol tartrate inhalation solution and a generic version of Xopenex HFA. Their global manufacturing footprint allows for broad market reach.
Teva Pharmaceutical Industries Ltd.: A leading global generics manufacturer, Teva is a key supplier of levalbuterol tartrate in various formulations. Teva offers both generic levalbuterol tartrate inhalation solution and an inhalation aerosol product.
Cipla Ltd.: Another prominent Indian pharmaceutical company, Cipla is involved in the production of levalbuterol tartrate API and finished products. Cipla supplies levalbuterol tartrate inhalation solutions to multiple markets.
Viatris Inc. (formerly Mylan N.V.): Viatris manufactures and distributes a generic version of levalbuterol tartrate inhalation aerosol, contributing to market competition.
Generic Pharmaceutical Manufacturers: Numerous smaller and regional generic drug manufacturers also source levalbuterol tartrate API to produce finished dosage forms for their respective markets. These include companies like Accord Healthcare and Aurobindo Pharma.

The sourcing of levalbuterol tartrate API often involves specialized chemical manufacturers. While specific API suppliers are not always publicly disclosed due to business-to-business confidentiality agreements, large pharmaceutical companies may have internal API manufacturing capabilities or rely on contracted third-party manufacturers, predominantly in India and China.

Patent Landscape and Market Exclusivity

The patent landscape surrounding levalbuterol tartrate, particularly for the branded product Xopenex HFA, has been complex, with multiple patent challenges affecting generic market entry timelines. The primary patent protecting the original formulation and its delivery device has faced litigation.

Key Patents and Litigation:

Xopenex HFA (Levalbuterol Tartrate Inhalation Aerosol): The U.S. Food and Drug Administration (FDA) approved Xopenex HFA (brebuhaler) in 2005. The patent for the drug and its delivery system has been a focal point of legal disputes.
- U.S. Patent No. 5,639,723: This patent, among others, has been litigated. It pertains to the use of levalbuterol as a therapeutic agent.
- Patent Expiration and Litigation: The primary patents for Xopenex HFA were originally set to expire around 2014. However, Sun Pharmaceutical Industries filed an Abbreviated New Drug Application (ANDA) for a generic version, initiating patent litigation. This led to a series of legal battles.
- District Court and Federal Circuit Rulings: In 2014, the U.S. District Court for the District of Delaware ruled that Sun Pharma did not infringe certain patents related to Xopenex HFA. This ruling was appealed. Subsequently, the U.S. Court of Appeals for the Federal Circuit vacated and remanded the decision, leading to further proceedings.
- Settlements and Market Entry: While specific settlement details are often confidential, these legal challenges have influenced the timing of generic levalbuterol tartrate inhalation aerosol market entry. Generic versions have become available following these legal resolutions.
Levalbuterol Tartrate Inhalation Solution: Patents related to the inhalation solution formulation and its use may also exist, though they have generally been less litigated than those for the HFA aerosol. Generic versions of the inhalation solution have entered the market with less pronounced patent-related delays.

Impact on Generic Availability:

The protracted patent litigation for Xopenex HFA has delayed the entry of generic levalbuterol tartrate inhalation aerosol products into the U.S. market compared to earlier expectations. This has allowed the branded product to maintain a longer period of market exclusivity. However, with the resolution of these disputes, a competitive generic market has emerged, increasing accessibility and potentially reducing prices.

The market for levalbuterol tartrate is characterized by a high degree of generic competition, particularly for the inhalation solution. The inhalation aerosol segment, while now populated by generics, experienced a more delayed generic entry due to intellectual property challenges.

Regulatory Approvals and Market Status

Regulatory approvals from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are critical for market access. Manufacturers must demonstrate bioequivalence for generic products.

Key Regulatory Considerations:

FDA Approval: Generic versions of levalbuterol tartrate products require FDA approval through an ANDA. This process verifies that the generic drug is bioequivalent to the branded reference listed drug.
EMA Approval: In Europe, similar procedures are followed, requiring marketing authorization for generic products.
Pharmacopeial Standards: Manufacturers adhere to standards set by pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.), to ensure drug quality, purity, and strength.
Exclusivity Periods: Regulatory agencies grant market exclusivity periods for new drug approvals, including for orphan drugs or new formulations. For levalbuterol tartrate, the original patent exclusivity for Xopenex HFA was the primary driver of market protection.

Market Dynamics:

The U.S. market for levalbuterol tartrate is substantial, driven by the prevalence of asthma and other obstructive airway diseases. The availability of multiple generic suppliers has led to a competitive pricing environment.

Competition in Inhalation Solution: The levalbuterol tartrate inhalation solution market is highly competitive, with numerous generic manufacturers offering the product.
Competition in Inhalation Aerosol: The levalbuterol tartrate inhalation aerosol market has seen increased generic competition following the resolution of patent disputes related to Xopenex HFA. This has introduced more cost-effective treatment options.

The sustained demand for bronchodilators in respiratory care ensures a stable market for levalbuterol tartrate. The emergence of generic alternatives continues to influence market share and pricing strategies of both branded and generic manufacturers.

Manufacturing and Quality Control

The production of levalbuterol tartrate API and finished drug products demands stringent adherence to Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy.

Manufacturing Standards:

API Synthesis: The synthesis of levalbuterol tartrate API involves complex chemical processes. Manufacturers must control reaction conditions, impurities, and chiral purity, as levalbuterol is the (R)-enantiomer of albuterol.
Chiral Purity: Ensuring high enantiomeric purity is paramount. The presence of the inactive (S)-enantiomer can potentially lead to unwanted side effects or reduced efficacy. Analytical methods like chiral chromatography are used for quality control.
Finished Dosage Form Manufacturing: The manufacturing of inhalation products, such as solutions and aerosols, requires specialized equipment and controlled environments to ensure accurate dosing and particle size distribution.
- Inhalation Solution: Production involves precise dispensing and sterile filling of solutions.
- Inhalation Aerosol: Manufacturing of metered-dose inhalers (MDIs) requires precise propellant filling, valve assembly, and container sealing to ensure consistent dose delivery.
Quality Assurance and Control: Robust quality assurance systems are in place throughout the manufacturing process, from raw material testing to finished product release. This includes in-process testing, stability studies, and validation of analytical methods.
Regulatory Compliance: Manufacturers are subject to regular inspections by regulatory authorities (FDA, EMA, etc.) to ensure ongoing compliance with GMP and other relevant regulations.

Key Quality Parameters:

Assay: Determination of the levalbuterol tartrate content.
Impurities: Identification and quantification of process-related impurities and degradation products.
Enantiomeric Purity: Measurement of the ratio of (R)-levalbuterol to (S)-albuterol.
Particle Size Distribution (for aerosols): Critical for ensuring proper deposition in the lungs.
Dose Uniformity: Verification that each actuation of an MDI delivers a consistent dose.
Sterility (for inhalation solutions): Ensuring the absence of microbial contamination.

The commitment to rigorous quality control and adherence to global GMP standards is a prerequisite for all suppliers of levalbuterol tartrate to maintain market access and patient trust.

Pricing and Market Access Considerations

The pricing and market access of levalbuterol tartrate are influenced by patent status, generic competition, and formulary decisions by healthcare providers and payers.

Pricing Factors:

Generic Competition: The introduction of multiple generic versions of levalbuterol tartrate has significantly driven down prices for both inhalation solutions and, more recently, inhalation aerosols.
Brand Pricing: The branded Xopenex HFA was priced at a premium during its period of market exclusivity.
Reimbursement: Payer formularies and preferred drug lists impact market access. Generic levalbuterol tartrate products are generally preferred due to lower cost, provided they meet clinical efficacy and safety profiles.
Volume Discounts: Large purchasers, such as hospital systems and pharmacy benefit managers, can negotiate volume-based discounts with suppliers.
Manufacturing Costs: The cost of API synthesis, formulation, packaging, and regulatory compliance contributes to the overall pricing of the drug.

Market Access Strategies:

Generic Manufacturers: Focus on cost-effective manufacturing and broad distribution to capture market share. They often engage with payers to ensure formulary placement.
Branded Manufacturers: May employ strategies such as authorized generics or patent extensions (where legally permissible) to maintain market position. However, the trend favors generic availability post-patent expiry.
Healthcare Providers: Prescribing practices are influenced by patient cost-sharing, formulary status, and physician familiarity with generic alternatives.

The shift from branded exclusivity to a competitive generic market has generally improved patient access to levalbuterol tartrate treatments by reducing out-of-pocket costs and increasing the number of available product options.

Key Takeaways

Major suppliers of levalbuterol tartrate include Sun Pharmaceutical Industries, Teva Pharmaceutical Industries, Cipla, and Viatris, encompassing both API and finished dosage form manufacturing.
The patent landscape for levalbuterol tartrate, particularly for Xopenex HFA, has been characterized by prolonged litigation, delaying the entry of generic inhalation aerosol products.
Generic versions of levalbuterol tartrate inhalation solution have been available for a longer period and face intense market competition.
Regulatory compliance, including adherence to GMP and pharmacopeial standards, is critical for all suppliers to ensure product quality, safety, and market access.
The increasing availability of generic levalbuterol tartrate products has led to a competitive pricing environment and improved patient access to bronchodilator therapy.

Frequently Asked Questions

What is the primary indication for levalbuterol tartrate?

Levalbuterol tartrate is indicated for the treatment or prevention of bronchospasm in adult patients aged 6 years and older with reversible obstructive airway disease. It is also used for the prevention of exercise-induced bronchospasm in patients 6 years of age or older.

How does levalbuterol tartrate differ from albuterol?

Levalbuterol tartrate is the (R)-enantiomer of racemic albuterol. While albuterol is a mixture of two enantiomers, (R)-albuterol and (S)-albuterol, levalbuterol is a pure form of the (R)-enantiomer. This distinction is important as studies suggest (R)-albuterol may be the pharmacologically active component responsible for bronchodilation, with (S)-albuterol potentially having counter-regulatory effects.

What are the common dosage forms for levalbuterol tartrate?

Levalbuterol tartrate is primarily available as a metered-dose inhalation aerosol and as an inhalation solution for nebulization.

Who are the key regulatory bodies overseeing the approval of levalbuterol tartrate products?

The primary regulatory bodies include the U.S. Food and Drug Administration (FDA) for products marketed in the United States and the European Medicines Agency (EMA) for products marketed in the European Union. Other national regulatory authorities also oversee approvals in their respective regions.

What is the significance of chiral purity for levalbuterol tartrate?

Chiral purity is critical because levalbuterol tartrate is a single enantiomer product. Ensuring a high percentage of the (R)-enantiomer and minimizing the presence of the (S)-enantiomer is essential for optimal therapeutic efficacy and to avoid potential side effects associated with the less active or inactive enantiomer.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/information-drug-labeling/approved-drug-products-therapeutic-equivalence-evaluations-orange-book [2] Sun Pharmaceutical Industries Ltd. (n.d.). Products. Retrieved from https://www.sunpharma.com/products [3] Teva Pharmaceutical Industries Ltd. (n.d.). Products. Retrieved from https://www.tevapharm.com/products [4] Cipla Ltd. (n.d.). Products. Retrieved from https://www.cipla.com/products [5] Viatris Inc. (n.d.). Products. Retrieved from https://www.viatris.com/en/Products [6] Court decisions and patent litigation databases (e.g., LexisNexis, Westlaw). (Information on specific patent cases related to Xopenex HFA). [7] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.usp.org/products/usp-nf [8] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-263

Suppliers and packagers for generic pharmaceutical drug: LEVALBUTEROL TARTRATE