BREVIBLOC IN PLASTIC CONTAINER Drug Patent Profile

When do Brevibloc In Plastic Container patents expire, and when can generic versions of Brevibloc In Plastic Container launch?

Brevibloc In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in BREVIBLOC IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brevibloc In Plastic Container

A generic version of BREVIBLOC IN PLASTIC CONTAINER was approved as esmolol hydrochloride by HIKMA on August 10^th, 2004.

Summary for BREVIBLOC IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for BREVIBLOC IN PLASTIC CONTAINER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREVIBLOC IN PLASTIC CONTAINER	Injection	esmolol hydrochloride	10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags	019386	1	2014-01-31

US Patents and Regulatory Information for BREVIBLOC IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	AP	RX	Yes	Yes

International Patents for BREVIBLOC IN PLASTIC CONTAINER

See the table below for patents covering BREVIBLOC IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2002309475
European Patent Office	0065542	COMPOUNDS SUITABLE FOR TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
Poland	216192
Czech Republic	20023825
Italy	8547927

Investment and Fundamentals Analysis of Brevibloc in Plastic Container

Last updated: February 23, 2026

What is the current market positioning of Brevibloc in plastic containers?

Brevibloc (esmolol hydrochloride) is a short-acting beta-1 selective adrenergic receptor blocker used primarily in acute settings such as intraoperative and postoperative hypertension, tachycardia, and arrhythmias. It is supplied in vials, traditionally glass, but recent formulations include plastic containers to meet safety and handling demands. The shift to plastic ensures better safety, lower breakage risk, and compatibility with modern hospital inventory logistics.

How does the manufacturing and formulation trend influence the investment landscape?

The transition to plastic packaging represents an industry trend driven by safety regulations, cost-efficiency, and ease of handling. Pharmaceutical companies invest in developing stable formulations compatible with plastic containers, reducing sterilization and contamination risks. For Brevibloc, the plastic container version enhances market accessibility, especially in outpatient and emergency settings.

Major contract manufacturers and brand owners prioritize scalable production of stable plastic formulations. The development timelines span 12-24 months, depending on regulatory approval processes.

What are the regulatory dynamics impacting Brevibloc plastic formulations?

Regulatory bodies such as the FDA and EMA require clear documentation on stability, compatibility, and safety of drug formulations in new packaging. The switch to plastic containers necessitates submission of supplementary new drug applications or variations. Validation data must show no interaction between drug and container materials over shelf life.

The timeline for approval varies but generally takes 6-12 months, contingent on submission completeness. Regulatory acceptance influences manufacturing scale-up and commercial distribution.

How do market dynamics and demand projections shape investment decisions?

Demand for Brevibloc remains stable in operational healthcare settings—per reports from IQVIA and similar sources, oral and injectable beta-blockers sold globally account for an estimated USD 1.2 billion annually. While competition from other short-acting beta-blockers exists, Brevibloc's rapid onset and short duration give it clinical leverage.

Plastic container formulations are projected to increase sales penetration by 15-20% over the next 3-5 years. This growth is driven by hospital procurement preferences favoring container durability and safety. The market growth rate from formulations in plastic is expected to outpace traditional glass variants due to these safety and logistical advantages.

What are key cost and pricing considerations?

Manufacturing costs for plastic containers are approximately 20-30% lower than glass counterparts, factoring in raw materials and handling. Pricing strategies are aligned with hospital procurement systems, with list prices around USD 20-25 per vial (10 mg/mL). Volume discounts and long-term contracts influence profitability.

Supply chain costs hinge on source materials, regulatory compliance, and economies of scale. The introduction of plastic formulations warrants evaluation of potential patent protections, which may affect pricing power.

How do patent and competitive patent landscapes influence the investment outlook?

Brevibloc’s core patents for formulation and delivery expire in the U.S. by 2023, with subsequent filings in other regions. However, secondary patents on specific formulations or packaging may extend exclusivity.

Key competitors include esmolol generics and brands like Bisoprolol, which do not have direct plastic container equivalents but influence market share via price competition. The development of proprietary packaging could serve as a differentiation point but must navigate existing patent thickets.

What is the outlook for R&D investment and future product pipeline?

R&D investments targeting stable, bioequivalent formulations in plastic are ongoing. Opportunities include developing preservative-free, pre-filled syringe systems, and compatibility with infusion pumps. These innovations require capital outlays but can yield premium pricing and competitive advantages.

Pipeline projects forecast phase 2/3 trials within 18-24 months, pending regulatory engagements. Successful development could command higher margins and lock in market share.

What are the risks and mitigation strategies?

Key risks include delays in regulatory approval, formulation stability issues, and patent expiries. Market risk arises from generic competition and hospital procurement cycles. Supply chain disruptions pose additional vulnerabilities.

Mitigation involves early engagement with regulators, securing patent protections, diversifying manufacturing sources, and investing in differentiated formulations. Strategic partnerships with contract manufacturing organizations (CMOs) can also reduce operational risks.

Key Takeaways

• Transition to plastic containers enhances safety, reduces costs, and aligns with hospital procurement trends, supporting revenue growth.
• Regulatory timelines for approval of new packaging are critical; delays can impact market rollout.
• Market demand for short-acting beta-blockers remains steady, with plastic formulations expected to increase sales share.
• Cost advantages for plastic over glass support margin improvements, provided regulatory hurdles are met.
• Patent expiries and the competitive landscape influence profitability; innovative packaging can serve as a differentiation point.
• R&D efforts focus on enhancing delivery systems, with potential for premium pricing on advanced formulations.

FAQs

1. What are the primary safety benefits of switching to plastic containers?
   Plastic containers reduce breakage risk and simplify handling, especially in emergency and out-of-hospital settings, improving safety for users and storage.

2. How long does regulatory approval for new plastic formulations usually take?
   Typically, 6-12 months for submission review, depending on the completeness of data and regional regulatory agency workload.

3. Can patent protections significantly extend Brevibloc’s market exclusivity?
   Yes; secondary patents on formulation or packaging can extend exclusivity beyond original patent expiries, delaying generic entry.

4. What factors influence the pricing strategy of Brevibloc in plastic containers?
   Manufacturing costs, regulatory status, hospital procurement contracts, and competitive pricing from generics shape the pricing strategy.

5. Are there supply chain risks associated with plastic container manufacturing?
   Yes; reliance on specific raw materials such as medical-grade plastics and potential disruptions can affect supply reliability.

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References

1. IQVIA (2022). Global Pharmaceutical Market Insight.
2. U.S. Food and Drug Administration (2021). Guidance for Industry – Development of Drug-Device Combination Products.
3. Patent and Trademark Office (2022). Patent Expiry Data for Esmolol.
4. MarketsandMarkets (2021). Pharmaceutical Packaging Market by Material, Application and Region.
5. European Medicines Agency (2022). Guidelines on the Chemistry of Pharmaceutical Packaging.