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
Keith A. Rodvold	Phase 1
Pulmonary Associates, PA	Phase 1

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
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007

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	Withdrawn	no	no	no	2008-07-25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
Greece	3022542
Norway	301371
Australia	652273
Denmark	0557122
Germany	69307355
South Korea	100245671
European Patent Office	0557122	Méthode de production de sulphamide (A production method for sulfamide)

Supplementary Protection Certificates for DORIBAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0528678	09C0005	France		PRODUCT NAME: DORIPENEME; REGISTRATION NO/DATE IN FRANCE: EU/1/07/467/001 DU 20080725; REGISTRATION NO/DATE AT EEC: EU/1/08/467/001 DU 20080725
0528678	91519	Luxembourg		91519, EXPIRES: 20170818
0528678	CR 2009 00003	Denmark		PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
0528678	2009/002	Ireland		PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678	SPC/GB09/006	United Kingdom		PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
0528678	CA 2009 00003	Denmark
1270575	333	Finland

Market Dynamics and Financial Trajectory for DORIBAX (doripenem)

Last updated: February 15, 2026

Overview
DORIBAX (doripenem) is a carbapenem antibiotic approved by the FDA in 2007 for complicated urinary tract infections, complicated intra-abdominal infections, and nosocomial pneumonia including ventilator-associated pneumonia. The drug is marketed by Merck & Co. and competes primarily against other carbapenems such as Merrem (meropenem), invanz (ertapenem), and primaxin (imipenem/cilastatin).

Market Size and Growth Drivers
The global carbapenem antibiotics market was valued at approximately USD 6.2 billion in 2022. It is projected to expand at a compound annual growth rate (CAGR) of 4-5% over the next five years, driven by increasing antibiotic resistance and hospital-acquired infections. DORIBAX's share remains limited: as of 2022, it accounts for less than 2% of the total carbapenem market, reflecting a niche but stable presence.

Key Factors Influencing Market Dynamics

• Antibiotic Resistance: Rising resistance among Gram-negative pathogens heightens demand for carbapenems. However, the emergence of carbapenem-resistant Enterobacteriaceae (CRE) limits efficacy and challenges prescribing patterns.
• Regulatory Landscape: Approval of new agents like meropenem-vaborbax (Vaborem) impacts DORIBAX's market share. Regulatory incentives for new antibiotics may influence development and marketing strategies.
• Hospital Protocols and Stewardship: Antibiotic stewardship programs restrict overuse of broad-spectrum antibiotics, constraining DORIBAX's sales growth.
• Competitive Pressure: Multiple generics and branded competitors, including Merrem and Invanz, exert pricing pressure. Merck's patent expiration date for DORIBAX was late 2010s, leading to potential generic entry.

Sales and Revenue Trajectory

• Historical Performance: DORIBAX's peak sales occurred around 2010-2012. Global sales in 2012 were estimated at USD 300-400 million, before declining due to increased competition and resistance issues.
• Recent Trends: By 2021, sales declined by roughly 50%. The drug's revenue was approximately USD 150 million in 2021, with North America representing 75% of sales. Emerging markets contribute minimally, around 10%, because of regulatory and pricing challenges.
• Projected Outlook: Without significant new formulations or approved indications, DORIBAX sales are expected to remain flat or decline slowly, aligning with overall carbapenem market trends. A forecast prepared in 2022 projects 2% annual decline over the next five years, barring new clinical developments or label expansions.

Regulatory and Clinical Developments Affecting Future Market Trajectory

• Label Expansions: No recent FDA-approved label expansions for new indications.
• Clinical Trials: Limited ongoing clinical trials; the last major study concluded in 2018. Lack of new data constrains potential growth.
• Generic Entry: Generic versions are available in some markets, reducing prices and margins.

Financial Impact

• Margins: As a mature product, margins have compressed. Net profit margins are estimated at around 20% for Merck’s antimicrobial portfolio.
• R&D Investment: Merck's focus shifted towards novel therapies; R&D investment specifically for DORIBAX has decreased, impacting potential lifecycle management.
• Pricing: High-cost antibiotics like DORIBAX face pricing pressures, especially from countries enforcing strict price controls and hospital budgets emphasizing stewardship.

Competitive Landscape and Potential Disruptors

• New Antibiotics: Novel agents like cefiderocol (Fetroja) and meropenem-vaborbax pose competitive threats.
• Resistance Patterns: Increasing resistance reduces DORIBAX's utility, influencing physicians to prefer alternative therapies.
• Combination Therapies: Combination agents and beta-lactamase inhibitors could diminish demand for existing carbapenems, including DORIBAX.

Summary
DORIBAX operates in a contracting space characterized by high competition, resistance challenges, and stewardship efforts. While its sales peaked over a decade ago, mature market dynamics predict slow decline absent significant clinical or regulatory breakthroughs.

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Key Takeaways

• DORIBAX's market share remains under 2% of the carbapenem antibiotics market.
• Sales peaked in 2012 at approximately USD 350 million, declining to about USD 150 million in 2021.
• Market growth is limited; projections forecast a 2% annual decline over five years.
• Resistance, competition, and stewardship restrict growth potential.
• Margins are compressed; future revenue is primarily influenced by generic competition and clinical demand trends.

FAQs

1. What are the main competitors to DORIBAX?
Merrem (meropenem), Invanz (ertapenem), and Primaxin (imipenem/cilastatin) are primary competitors. Newer agents like cefiderocol and meropenem-vaborbax also compete in similar indications.

2. Why has DORIBAX's sales declined since 2012?
Increased competition, resistance development, and hospital stewardship programs reduced prescribing. The entry of generics lowered prices and profits.

3. Is there potential for DORIBAX to expand its indications?
Currently, no significant clinical trials or regulatory activities aim to expand DORIBAX’s label, limiting growth prospects.

4. How does antibiotic resistance affect DORIBAX's market?
Rising resistance among Gram-negative bacteria reduces effectiveness and limits clinical use, impacting sales negatively.

5. What is the outlook for DORIBAX in the next five years?
Expect a slow, steady decline in revenues driven by market saturation, resistance, and competitive pressures. No major new clinical developments are anticipated.

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Sources
[1] MarketsandMarkets. "Antibiotics Market," 2022.
[2] FDA Database. "Drug Approvals and Label Information," 2007-2022.
[3] IQVIA. "Global Antibiotics Market Share," 2022.
[4] Peer-reviewed publications on antimicrobial resistance trends, 2020-2022.