Suppliers and packagers for TERBUTALINE SULFATE

TERBUTALINE SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	076887	ANDA	Henry Schein, Inc.	0404-9962-01	1 VIAL in 1 BAG (0404-9962-01) / 1 mL in 1 VIAL	2022-01-12
Fresenius Kabi Usa	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	076887	ANDA	Fresenius Kabi USA, LLC	63323-665-01	25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)	2011-03-10
Hikma Farmaceutica	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	078630	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9375-10	10 VIAL in 1 CARTON (0143-9375-10) / 1 mL in 1 VIAL (0143-9375-01)	2009-05-20
Hikma Farmaceutica	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	078630	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9746-10	10 VIAL in 1 CARTON (0143-9746-10) / 1 mL in 1 VIAL (0143-9746-01)	2009-05-20
Hikma Farmaceutica	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	078630	ANDA	Henry Schein, Inc.	0404-9778-01	1 VIAL in 1 BAG (0404-9778-01) / 1 mL in 1 VIAL	2025-10-07
Hikma Farmaceutica	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	078630	ANDA	Medical Purchasing Solutions. LLC	71872-7080-1	1 VIAL in 1 BAG (71872-7080-1) / 1 mL in 1 VIAL	2009-05-20
Impax Labs	TERBUTALINE SULFATE	terbutaline sulfate	TABLET;ORAL	075877	ANDA	Amneal Pharmaceuticals of New York LLC	0115-2611-01	100 TABLET in 1 BOTTLE (0115-2611-01)	2001-06-26

Terbutaline Sulfate: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

This report analyzes the supply chain and patent landscape for terbutaline sulfate, a short-acting beta-2 adrenergic receptor agonist used to treat bronchospasm associated with asthma and chronic obstructive pulmonary disease (COPD). Key manufacturers and their production capacities, alongside active patent filings and expiry dates, are identified to inform R&D and investment strategies.

What is Terbutaline Sulfate?

Terbutaline sulfate is a bronchodilator administered via inhalation or oral routes. It functions by relaxing the smooth muscles of the airways, leading to improved airflow. The chemical structure of terbutaline sulfate is 1-(3,5-dihydroxyphenyl)-2-(tert-butylamino)ethanol sulfate. Its primary therapeutic use is in managing reversible airway obstruction.

Who are the Primary Manufacturers of Terbutaline Sulfate API?

Several pharmaceutical manufacturers produce the active pharmaceutical ingredient (API) for terbutaline sulfate. Production is concentrated among companies with established expertise in small molecule synthesis and adherence to stringent Good Manufacturing Practices (GMP).

• Key Manufacturers:
  • Sanofi S.A.: A global pharmaceutical company with a significant presence in respiratory therapeutics. Sanofi manufactures terbutaline sulfate API and finished dosage forms. Production capacity figures are proprietary.
  • Teva Pharmaceutical Industries Ltd.: A leading global generics manufacturer. Teva produces terbutaline sulfate API, contributing to its availability in the generics market. Specific production volumes are not publicly disclosed.
  • Mylan N.V. (now Viatris Inc.): Another major generics player. Viatris supplies terbutaline sulfate API and various formulations. Production data remains undisclosed.
  • Novartis AG: While primarily known for its innovative portfolio, Novartis has had historical involvement in respiratory medications that may include terbutaline sulfate production or sourcing for certain markets.
  • Indian and Chinese API Manufacturers: A significant portion of global API production, including for terbutaline sulfate, is sourced from India and China. Companies such as Lupin Limited, Dr. Reddy's Laboratories, and various Chinese chemical manufacturers are known API suppliers, although specific terbutaline sulfate production capacities are not publicly detailed. These manufacturers often operate on a contractual basis for global pharmaceutical companies.

The market for terbutaline sulfate API is characterized by a balance between established pharmaceutical giants and specialized API manufacturers, particularly in Asia. Pricing and supply availability are influenced by raw material costs, regulatory compliance, and global demand for respiratory treatments.

What is the Patent Landscape for Terbutaline Sulfate?

The patent landscape for terbutaline sulfate is largely characterized by early composition of matter patents that have long since expired. Current patent activity focuses on manufacturing processes, formulations, and novel delivery systems.

• Composition of Matter Patents:

  • The original patents covering the terbutaline molecule itself expired decades ago. For instance, the initial patents filed by AstraZeneca (formerly AB Astra) in the late 1960s and early 1970s have expired. These patents established the novelty and utility of terbutaline.

• Manufacturing Process Patents:

  • While the core synthesis pathway is well-established, companies have sought patents for optimized or novel manufacturing processes that offer advantages in yield, purity, cost-efficiency, or environmental impact.
  • Example Patent Area: Patents may cover specific catalytic steps, purification techniques, or methods for achieving particular polymorphic forms of terbutaline sulfate. Searching patent databases (e.g., USPTO, EPO, WIPO) reveals filings related to "improved methods for synthesizing terbutaline" or "purification of terbutaline sulfate."
  • Representative Patent Filing Period: Recent filings for process improvements have occurred within the last 5-15 years, often from generic manufacturers or specialized chemical process developers aiming to differentiate their API production.

• Formulation and Delivery System Patents:

  • Patents are frequently filed for new formulations designed to enhance efficacy, patient compliance, or delivery. This is particularly relevant for inhalation devices.
  • Inhalation Devices: Innovations in metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizer solutions can be protected by patents. These patents often cover the device's mechanical design, propellant composition (for MDIs), or specific excipients that improve drug dispersion or stability.
  • Extended-Release Formulations: While terbutaline is primarily used as a short-acting agent, patents might exist for modified-release oral formulations to alter its pharmacokinetic profile, although this is less common for terbutaline compared to other bronchodilators.
  • Combination Therapies: Patents could protect combinations of terbutaline sulfate with other active ingredients, although such combinations are not prevalent in current therapeutic guidelines for terbutaline.

• Key Patent Holders (Recent Filings):

  • Generic Manufacturers: Companies like Teva, Viatris, and Sun Pharma may file patents related to process optimization or specific generic formulations designed for market entry post-exclusivity.
  • Specialized Pharmaceutical Technology Companies: Firms focusing on drug delivery technologies may hold patents for novel inhaler devices or formulation techniques applicable to existing APIs like terbutaline sulfate.

• Patent Expiry:

  • The critical aspect for many pharmaceutical businesses is the expiry of formulation or delivery system patents, which opens the door for generic competition.
  • Generic Accessibility: Given the age of the composition of matter patent, generic versions of oral and standard inhaled terbutaline sulfate are widely available and have been for many years. Patent expiry for specific branded formulations or delivery devices would be the primary driver for new generic entrants in those segments.

Analysis of Supply Chain Risks and Opportunities

The supply chain for terbutaline sulfate presents both risks and opportunities for pharmaceutical companies. Understanding these dynamics is crucial for ensuring consistent product availability and for identifying potential areas for innovation and market expansion.

Supply Chain Risks

• Raw Material Volatility: The synthesis of terbutaline sulfate relies on precursor chemicals. Fluctuations in the price and availability of these raw materials, often sourced globally, can impact API manufacturing costs and lead times. Geopolitical instability, trade disputes, or disruptions at key chemical intermediate suppliers can create supply chain bottlenecks.
• Regulatory Hurdles: API manufacturers must adhere to stringent GMP regulations imposed by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Any failure to comply can result in product recalls, manufacturing suspensions, or import alerts, leading to significant supply disruptions. Changes in regulatory requirements can also necessitate costly process modifications.
• Geographic Concentration of Manufacturing: A significant portion of API manufacturing is concentrated in India and China. While this offers cost advantages, it also creates a dependency on these regions. Natural disasters, pandemics, or changes in national policies in these countries can have a disproportionate impact on global supply.
• Quality Control and Impurity Profiles: Ensuring consistent API quality is paramount. Deviations in impurity profiles can lead to batch rejections or regulatory actions. Robust quality control systems are essential, but unforeseen issues can arise, affecting product release and availability.
• Intellectual Property Challenges: While primary patents have expired, disputes over process patents or new formulation patents can arise. Litigation or the threat of litigation can create uncertainty and impact market entry strategies for generic products.

Supply Chain Opportunities

• Process Optimization and Cost Reduction: Continuous innovation in chemical synthesis and manufacturing processes can lead to significant cost reductions for API production. Companies that invest in R&D for more efficient, higher-yield synthesis routes can gain a competitive advantage and improve profit margins.
• Development of Novel Delivery Systems: The development of improved or novel delivery systems for terbutaline sulfate, such as more patient-friendly inhalers or formulations with enhanced stability, offers opportunities for market differentiation and potentially longer product exclusivity. This could involve new device technologies or advanced formulation science.
• Geographic Diversification of Manufacturing: Companies seeking to mitigate supply chain risks may explore diversifying their API manufacturing base to include facilities in different geographic regions. This can enhance supply chain resilience and reduce reliance on single-source locations.
• Vertical Integration: Pharmaceutical companies that manufacture both the API and the finished dosage form can achieve greater control over their supply chain, potentially leading to cost efficiencies and more predictable product availability.
• Strategic Partnerships: Collaborations between API manufacturers, formulation developers, and device engineers can accelerate the development and commercialization of innovative terbutaline sulfate products. These partnerships can pool expertise and resources, reducing time-to-market.

Key Takeaways

• Terbutaline sulfate API production is dominated by established pharmaceutical companies and a significant number of manufacturers in India and China.
• Original composition of matter patents have expired, leading to widespread generic availability of the API.
• Current patent activity is focused on manufacturing process improvements and novel drug delivery systems, particularly for inhalation devices.
• Supply chain risks include raw material volatility, regulatory compliance, and geographic concentration of manufacturing.
• Opportunities exist in process optimization, development of advanced delivery systems, supply chain diversification, and strategic partnerships.

Frequently Asked Questions

What is the typical lead time for terbutaline sulfate API production?

Lead times for terbutaline sulfate API production can vary from 3 to 9 months, depending on the manufacturer's capacity, raw material availability, and current production schedules. Batch sizes and specific quality requirements also influence this timeline.

Are there any bioequivalent generics of terbutaline sulfate available in the U.S. market?

Yes, numerous bioequivalent generic versions of oral and inhaled terbutaline sulfate are available in the U.S. market, indicated by their FDA approval. These generics demonstrate comparable pharmacokinetic and pharmacodynamic profiles to their branded counterparts.

What are the primary quality control parameters for terbutaline sulfate API?

Key quality control parameters for terbutaline sulfate API include assay (potency), identification, related substances (impurities), residual solvents, heavy metals, water content, and microbial limits, all as specified by pharmacopeial monographs (e.g., USP, EP).

What is the current regulatory status of terbutaline sulfate manufacturing facilities?

Manufacturing facilities producing terbutaline sulfate API are subject to ongoing inspections by regulatory bodies like the FDA and EMA. Facilities must maintain compliance with current Good Manufacturing Practices (cGMP) to ensure product quality and patient safety. Any warning letters or import alerts would impact supply.

Can terbutaline sulfate API be used for veterinary applications?

While primarily used in human medicine, terbutaline sulfate can also be used in veterinary medicine for conditions such as asthma and bronchitis in animals. API manufacturers must ensure their product meets the specific regulatory standards for the intended veterinary market if applicable.

What are the key excipients used in terbutaline sulfate inhalation formulations?

Common excipients in terbutaline sulfate inhalation formulations include propellants (e.g., hydrofluoroalkanes for MDIs), co-solvents (e.g., ethanol), stabilizers, and surfactants. The specific excipients are proprietary to each formulation and are often covered by patents.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases [2] European Medicines Agency. (n.d.). Find Medicine. Retrieved from https://www.ema.europa.eu/en/medicines [3] World Intellectual Property Organization. (n.d.). Patentscope. Retrieved from https://patentscope.wipo.int/ [4] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/ [5] United States Pharmacopeia. (n.d.). USP-NF Online. Retrieved from https://www.uspnf.com/