DICLOXACILLIN SODIUM Drug Patent Profile

Which patents cover Dicloxacillin Sodium, and when can generic versions of Dicloxacillin Sodium launch?

Dicloxacillin Sodium is a drug marketed by Aurobindo Pharma, Chartwell Rx, Teva, and Apothecon. and is included in four NDAs.

The generic ingredient in DICLOXACILLIN SODIUM is dicloxacillin sodium. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dicloxacillin Sodium

A generic version of DICLOXACILLIN SODIUM was approved as dicloxacillin sodium by TEVA on June 3^rd, 1982.

Summary for DICLOXACILLIN SODIUM

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	1
Patent Applications:	565
DailyMed Link:	DICLOXACILLIN SODIUM at DailyMed

Recent Clinical Trials for DICLOXACILLIN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all DICLOXACILLIN SODIUM clinical trials

Pharmacology for DICLOXACILLIN SODIUM

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for DICLOXACILLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for DICLOXACILLIN SODIUM

J01CF	Beta-lactamase resistant penicillins
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01CF	Beta-lactamase resistant penicillins
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01CF	Beta-lactamase resistant penicillins
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DICLOXACILLIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	216845-001	Sep 23, 2022	AB	RX	No	No
Teva	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	062286-002	Jun 3, 1982	AB	RX	No	Yes
Chartwell Rx	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	061454-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	DICLOXACILLIN SODIUM	dicloxacillin sodium	FOR SUSPENSION;ORAL	061455-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Aurobindo Pharma	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	216845-002	Sep 23, 2022	AB	RX	No	No
Chartwell Rx	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	061454-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	062286-001	Jun 3, 1982	AB	RX	No	No

Market Dynamics and Financial Trajectory for Dicloxacillin Sodium

Last updated: February 20, 2026

Dicloxacillin sodium is a penicillinase-resistant beta-lactam antibiotic used primarily for bacterial infections resistant to other penicillins. The current market landscape for dicloxacillin sodium reflects its therapeutic role, regulatory status, manufacturing landscape, and competitive environment.

Market Size and Demand Drivers

The global demand for dicloxacillin sodium remains modest compared to broad-spectrum antibiotics. In 2022, the global antibiotics market was valued at approximately $53 billion, with penicillin derivatives accounting for a small segment due to limited indications and patent expiration periods [1].

Breakdown of key drivers:

• Infection prevalence: Staphylococcal infections are common, but increasing resistance to antibiotics diminishes the drug's effectiveness.
• Treatment protocols: Shifts toward alternative antibiotics due to resistance issues limit dicloxacillin sodium's use.
• Regulatory landscape: Approval in select countries restricts market expansion.
• Generics: As patents expired decades ago, production is dominated by generic manufacturers, resulting in low prices and limited profit margins.

Manufacturing and Supply Considerations

Several companies, including Sandoz, Lupin, and Mylan, produce generic dicloxacillin sodium. Manufacturing costs are approximately $0.50–$1.00 per dose, with wholesale prices around $2–$5 per 500 mg capsule [2].

Supply chain stability is impacted by:

• Raw material availability for penicillin derivatives.
• Regulatory inspection and quality compliance.
• Batch-to-batch consistency concerns due to complex synthesis processes.

Competitive Environment

Dicloxacillin sodium faces competition from:

• Oral and IV alternatives: Cephalexin, clindamycin, and oxacillin.
• Resistance issues: Increasing MRSA prevalence reduces the drug’s efficacy.
• Market shift: Physicians favor broader-spectrum or newer antibiotics with better safety profiles.

Market share remains limited, primarily confined to niche therapeutic areas and specific regional markets.

Regulatory and Patent Status

• Patent expiry: The last patents expired in the late 1980s.
• Regulatory approval: Approved in the US, EU, and several Asian countries; some markets restrict its use due to resistance concerns.
• Reimbursement policies: Variable by country; many public health systems favor newer antibiotics with broader coverage.

Financial Trajectory

Revenue projections remain squeezed due to:

• Limited market growth: Market is shrinking as resistant strains diminish efficacy.
• Price erosion: Competition from generics depresses profit margins.
• Market segmentation: Geographic restrictions limit revenue potential.

Projected annual global sales for dicloxacillin sodium hover below $50 million, with some estimates as low as $20–$30 million in mature markets [3].

Future Outlook

Key factors influencing future financial trajectory:

• Resistance development: Rising MRSA and other resistant strains curtail use.
• New formulations: Limited pipeline; unlikely to significantly alter market dynamics.
• Regional variation: Some markets, like India and parts of Southeast Asia, report continued considerable use, maintaining a baseline revenue stream.
• Regulatory shifts: Potential for restrictions if resistance continues to increase.

In sum, the overall market for dicloxacillin sodium is static or declining, with minimal opportunity for growth absent new indications or formulations.

Key Takeaways

• The market is primarily driven by generic manufacturing, leading to low prices.
• Use has declined due to rising antibiotic resistance, especially MRSA.
• Revenue projections are stable but declining, with global sales under $50 million annually.
• Limited pipeline activity diminishes future market expansion potential.
• Regional markets may sustain some demand, particularly where resistance is low.

FAQs

1. Why is the market for dicloxacillin sodium limited?
Limited use stems from antibiotic resistance, especially MRSA, and competition from broader-spectrum or newer antibiotics.

2. Are there any significant patent protections?
No, patents expired in the late 1980s, resulting in widespread generic manufacturing.

3. Which regions still see considerable use of dicloxacillin sodium?
India, Southeast Asia, and some European countries maintain moderate usage, primarily in treating specific staphylococcal infections.

4. What are the main competitors to dicloxacillin sodium?
Cephalexin, oxacillin, clindamycin, and other antibiotics effective against staphylococcal infections.

5. Is there potential for market growth?
Limited unless new formulations or indications emerge; resistance trends suggest further decline.

References

[1] MarketsandMarkets. (2022). Antibiotics Market.
[2] IMS Health. (2021). Cost and pricing analysis for penicillin antibiotics.
[3] EvaluatePharma. (2022). Worldwide sales estimates for antibiotics.