DORIBAX Drug Patent Profile

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

Doribax is a drug marketed by Shionogi Inc and is included in one NDA.

The generic ingredient in DORIBAX is doripenem. There are five drug master file entries for this compound. Additional details are available on the doripenem profile page.

Summary for DORIBAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Drug Prices:	Drug price information for DORIBAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DORIBAX
DailyMed Link:	DORIBAX at DailyMed

See drug prices for DORIBAX

Recent Clinical Trials for DORIBAX

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

Sponsor	Phase
Janssen Pharmaceutica
Pulmonary Associates, PA	Phase 1
Janssen-Cilag Ltd.,Thailand	Phase 4

See all DORIBAX clinical trials

Paragraph IV (Patent) Challenges for DORIBAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DORIBAX	Injection	doripenem	250 mg/vial and 500 mg/vial	022106	1	2011-10-12

US Patents and Regulatory Information for DORIBAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010		DISCN	Yes	No
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007		DISCN	Yes	No

Expired US Patents for DORIBAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010	5,317,016
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007	8,247,402
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007	5,317,016
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010	8,247,402

EU/EMA Drug Approvals for DORIBAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Doribax	doripenem	EMEA/H/C/000891Doribax is indicated for the treatment of the following infections in adults:nosocomial pneumonia (including ventilator-associated pneumonia);complicated intra-abdominal infections;complicated urinary tract infections.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Withdrawn	no	no	no	2008-07-25

International Patents for DORIBAX

See the table below for patents covering DORIBAX around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2252205
European Patent Office	1270575	NOUVELLE FORME CRISTALLINE D'UN DERIVE DE PYRROLIDYLTHIOCARBAPENEM (NOVEL CRYSTAL FORM OF PYRROLIDYLTHIOCARBAPENEM DERIVATIVE)
China	1078718
Germany	60113243
China	1222508
European Patent Office	0528678	Dérivé de pyrrolidylthiocarbapénème ayant une activité antibacterienne (A pyrrolidylthiocarbapenem derivative with antibacterial activity)
China	1052474

Supplementary Protection Certificates for DORIBAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0528678	2009/002	Ireland		PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678	CA 2009 00003	Denmark
1270575	333	Finland
0528678	C300374	Netherlands		PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678	300374	Netherlands		300374, 20120818, EXPIRES: 20170817
0528678	SPC/GB09/006	United Kingdom		PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
0528678	C00528678/01	Switzerland		PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009

Market Dynamics and Financial Trajectory for DORIBAX

Last updated: July 29, 2025

Introduction

DORIBAX (doripenem for injection) stands as a broad-spectrum carbapenem antibiotic, primarily used to combat complicated urinary tract infections (cUTIs), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP). Since its FDA approval in 2007 and subsequent global distribution, DORIBAX's market performance reflects a complex interplay of clinical efficacy, competitive landscape, regulatory aspects, and evolving healthcare dynamics. This analysis explores the current market environment, growth trajectory, and factors shaping DORIBAX's financial prospects.

Market Landscape and Key Drivers

1. Therapeutic Market Environment

The antibiotic segment, especially carbapenems like DORIBAX, continues to be pivotal in managing nosocomial infections amid rising antimicrobial resistance (AMR). The increasing incidence of multidrug-resistant (MDR) pathogens, including resistant Pseudomonas aeruginosa and Acinetobacter baumannii, sustains demand for potent broad-spectrum agents such as DORIBAX. According to the CDC, antibiotic resistance causes over 2 million illnesses annually in the U.S. alone, with around 23,000 deaths, underscoring the ongoing need for effective antibiotics (CDC, 2022).

2. Competitive Dynamics

DORIBAX competes with other carbapenems—meropenem (Merrem), imipenem, and ertapenem—alongside newer agents like ceftazidime-avibactam and meritevib (meropenem-vaborbactam). The clinical efficacy, spectrum, and resistance patterns influence prescribing behaviors. Notably, despite its broad activity, DORIBAX faces competition due to concerns about promoting resistance and relatively high acquisition costs. The emergence of newer, combination antibiotics, with pharmacokinetic advantages, also impacts market share.

3. Regulatory and Reimbursement Factors

Regulatory approvals across key markets (U.S., Europe, Asia-Pacific) shape DORIBAX’s availability. Its inclusion in hospital formularies depends on local antimicrobial stewardship policies. Reimbursement frameworks, primarily under hospital coverage, influence prescribing decisions. Notably, reimbursement challenges may limit wider adoption, especially where healthcare systems emphasize cost containment.

4. Market Penetration and Adoption

DORIBAX's utilization is confined largely to inpatient settings, particularly intensive care units (ICUs). Growth is influenced by hospital antibiograms, stewardship programs favoring narrow-spectrum agents, and clinician familiarity. Efforts to expand indications and educate providers can bolster market penetration.

Financial Trajectory and Revenue Projections

1. Historical Financial Trends

While detailed public financial disclosures on DORIBAX are limited, Pfizer (the original marketer) experienced moderate revenues derived from its sales. Fragmented data suggests that DORIBAX achieved annual sales in the low hundreds of millions USD globally at peak periods before commercial challenges and competition intensified.

2. Revenue Drivers

• Increased Resistance and Demand: Escalating MDR cases are likely to sustain or increase demand, provided the drug remains clinically relevant and accessible.
• Generic Competition: The expiration of patent exclusivity tends to introduce generics, promising price reductions and broader access but pressuring original sales.
• Innovation and Line Extensions: Potential availability of combination formulations or new delivery methods could enhance revenue streams.
• Market Expansion: Penetrating emerging markets where antibiotic resistance is surging can boost sales volume.

3. Challenges Impacting Financial Trajectory

• Antibiotic Stewardship: Heightened stewardship efforts aim to curb unnecessary antibiotic use, especially broad-spectrum agents, which can limit DORIBAX’s application.
• Resistance Development: Emerging resistance mechanisms may diminish clinical effectiveness, thereby affecting sales.
• Regulatory and Competitive Changes: New entrants and alternative therapies could reduce DORIBAX’s market share.

4. Future Outlook and Growth Potential

Forecasts for DORIBAX's financial performance suggest a cautious trajectory. The antibiotic market's inherent volatility, combined with stewardship-driven prescribing, implies slow but steady revenue evolution. Global trends favorising antimicrobial resistance management and infection control indicate potential growth in markets with high MDR prevalence. Nonetheless, patent expiration and introduction of competing drugs are likely to cap long-term revenue growth.

Market Challenges and Opportunities

Challenges

• Antibiotic Resistance: Resistance development can weaken DORIBAX's efficacy, leading to decreased usage.
• Pricing Pressures: Cost containment measures in healthcare and generic competition suppress profit margins.
• Prescribing Behavior: Clinicians tend to reserve broad-spectrum antibiotics for resistant infections, limiting routine use.

Opportunities

• Combination Therapies: Developing combination formulations to extend shelf-life and clinical utility.
• Global Expansion: Targeting regions with rising MDR infections, such as Asia and Latin America.
• Stewardship Collaboration: Partnering with stewardship programs to educate clinicians about appropriate use, potentially expanding DORIBAX's niche.

Conclusion

DORIBAX remains a relevant agent within the hospital-based antimicrobial arsenal, driven by the global rise of resistant bacterial infections. While immediate financial performance faces headwinds from competitive, regulatory, and stewardship influences, the evolving landscape of antimicrobial resistance offers pathways for sustained, albeit moderated, growth. Strategic positioning—through innovation, global expansion, and stewardship alignment—will be crucial for optimizing DORIBAX's long-term financial trajectory.

Key Takeaways

• DORIBAX's market resilience hinges on the growing burden of MDR infections and limited alternatives.
• Competition from newer antibiotics and generics constrains revenue growth prospects.
• Stewardship programs and regulatory pressures necessitate strategic adaptation for sustained market presence.
• Expansion into high-burden regions presents significant growth opportunities.
• Ongoing innovation and collaboration with healthcare providers are vital for maintaining DORIBAX’s relevance and financial viability.

FAQs

Q1: How does antimicrobial resistance influence DORIBAX’s market prospects?
A: Rising antimicrobial resistance enhances the clinical need for potent agents like DORIBAX, supporting demand. However, resistance development against DORIBAX itself could curtail its effectiveness and market share over time.

Q2: What are the main competitive threats facing DORIBAX?
A: DORIBAX faces competition from other carbapenems, newer combination antibiotics, and generic versions, all of which can impact pricing, market share, and prescribing patterns.

Q3: How do regulatory policies affect DORIBAX’s revenue potential?
A: Regulations on antimicrobial use, approval processes, and reimbursement policies influence drug access and utilization, directly impacting revenue generation.

Q4: What role do global markets play in DORIBAX’s financial growth?
A: Countries with high MDR bacterial infections and limited healthcare infrastructure expansion represent significant growth opportunities for DORIBAX, especially if regulatory pathways are navigated effectively.

Q5: What future strategies could enhance DORIBAX’s market positioning?
A: Developing combination therapies, expanding into emerging markets, partnering with antimicrobial stewardship programs, and innovating delivery methods can help improve its market standing.

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Sources:
[1] Centers for Disease Control and Prevention (CDC), 2022. Antibiotic Resistance Threats in the United States.
[2] Pfizer Annual Reports and Market Data.
[3] Industry analysis reports on antimicrobial agents and resistance trends.
[4] Clinical guidelines and prescribing trends from Infectious Diseases Society of America.