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
Patent Applications:	4,403
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/000891 Doribax 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
China	1222508
South Korea	20020087446
South Africa	200207675	Novel crystal form of pyrrolidylthiocarbapenem derivative.
China	1113233
Australia	652273
China	1078718
Norway	301371

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	SPC/GB09/006	United Kingdom		PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
0528678	CA 2009 00003	Denmark
0528678	C300374	Netherlands		PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678	CR 2009 00003	Denmark		PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
0528678	300374	Netherlands		300374, 20120818, EXPIRES: 20170817
0528678	C00528678/01	Switzerland		PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009

DORIBAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doribax (Doripenem)

Introduction

Doribax, also known as doripenem, is a broad-spectrum carbapenem antibiotic used to treat severe bacterial infections, particularly in hospitalized patients. Here, we will delve into the market dynamics and financial trajectory of Doribax, highlighting its key drivers, challenges, and future prospects.

Market Drivers

Several factors drive the market for Doribax:

Rising Incidence of Multidrug-Resistant Infections

The increasing prevalence of multidrug-resistant bacterial infections has created a significant demand for effective antibiotics like Doribax. This trend is particularly pronounced in healthcare settings where the risk of such infections is higher[3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, have enhanced the accessibility and affordability of advanced antibiotics. This has contributed to the growing demand for Doribax in these markets[3].

Strategic Collaborations and Partnerships

Pharmaceutical companies are engaging in strategic collaborations and partnerships to improve the distribution channels and market reach of Doribax. These efforts have been instrumental in expanding its market presence[3].

Market Challenges

Despite the drivers, the Doribax market faces several challenges:

Stringent Regulatory Requirements

The development and approval process for antibiotics like Doribax is stringent, which can slow down market entry and expansion. Regulatory bodies closely monitor the safety and efficacy of these drugs, as seen in the FDA's label changes for Doribax[4].

Antibiotic Resistance and Safety Concerns

The emergence of antibiotic-resistant strains and safety concerns, such as the increased risk of death and lower clinical cure rates in certain conditions, pose significant challenges. For instance, the FDA has highlighted that Doribax carries an increased risk of death compared to other antibiotics in treating ventilator-associated pneumonia[4].

Competition from Alternative Antibiotics

Doribax faces competition from other antibiotics and newer therapeutics. This competition can impact its market share and financial performance, especially if alternative treatments are perceived as safer or more effective[3].

Financial Trajectory

The financial trajectory of Doribax is influenced by several key factors:

Market Size and Growth

The Doripenem market, which includes Doribax, is projected to exhibit a robust CAGR of 5.20% during the forecast period. In the United States, the market size is estimated to reach approximately $200 million by 2025, with a CAGR of around 4.5%. Similar growth trends are observed in other regions, such as the U.K., Thailand, and Malaysia[3].

Regional Performance

• North America: This region leads the market due to high healthcare expenditures and a robust demand for effective treatments against multidrug-resistant pathogens.
• Asia-Pacific: Emerging markets in this region, such as India and China, show significant growth potential due to large populations, increasing healthcare investments, and high penetration of generic drug manufacturers[1][3].

Revenue and Sales

The global carbapenem-based antibiotics market, which includes Doribax, is projected to reach US$ 5,346.62 million by 2028 from US$ 3,964.57 million in 2021, growing at a CAGR of 4.4%. This growth is driven by the increasing production of generic drugs and the expiry of patented antibiotics, which widens opportunities for generic manufacturers[1].

Distribution Channels

The distribution of Doribax is primarily through hospital pharmacies, which held the largest share of the carbapenem-based antibiotics market in 2021. This segment is expected to register the highest CAGR during the forecast period, indicating a strong demand for antibiotics in healthcare settings[1].

Key Players and Competitive Landscape

Major players in the Doribax market include Merck & Co. and Pfizer. These companies are focused on research and development to enhance the efficacy of Doripenem and expand its applications. The competitive landscape is characterized by strategic collaborations and partnerships aimed at improving distribution channels and market reach[1][3].

Future Trends and Opportunities

• Combination Therapies: There is a growing focus on developing combination therapies to combat antibiotic resistance. This trend presents opportunities for Doribax to be used in conjunction with other antibiotics to enhance its efficacy.
• Expanding Healthcare Infrastructure: The ongoing expansion of healthcare infrastructure in developing regions is expected to increase the demand for advanced antibiotics like Doribax.
• Clinical Trials and Research: Investment in clinical trials to demonstrate the efficacy of Doripenem against resistant pathogens could further bolster its adoption and market growth[3].

Impact of Regulatory Changes

Regulatory changes, such as the FDA's label updates for Doribax, can significantly impact its market dynamics. The revised label highlighting the risks associated with using Doribax for unapproved indications, such as ventilator-associated pneumonia, may influence prescribing practices and affect sales[4].

Key Takeaways

• The Doribax market is driven by the rising incidence of multidrug-resistant infections and advancements in healthcare infrastructure.
• Despite growth potential, the market faces challenges such as stringent regulatory requirements, antibiotic resistance, and competition from alternative antibiotics.
• The financial trajectory is positive, with a projected robust CAGR and significant market size in various regions.
• Hospital pharmacies are the primary distribution channels, and key players are focusing on research and development to enhance the drug's efficacy.

FAQs

1. What is Doribax used for? Doribax (doripenem) is used to treat adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections called pyelonephritis[4].

2. What are the key drivers of the Doribax market? The key drivers include the rising incidence of multidrug-resistant infections, advancements in healthcare infrastructure, and strategic collaborations among pharmaceutical companies[3].

3. What are the major challenges facing the Doribax market? The major challenges include stringent regulatory requirements, the emergence of antibiotic-resistant strains, and competition from alternative antibiotics[3].

4. How is the distribution of Doribax primarily managed? The distribution of Doribax is primarily managed through hospital pharmacies, which held the largest share of the carbapenem-based antibiotics market in 2021[1].

5. What are the future trends and opportunities for Doribax? Future trends include the development of combination therapies, expanding healthcare infrastructure in developing regions, and ongoing research into clinical trials to demonstrate efficacy against resistant pathogens[3].

Cited Sources:

1. Carbapenem-Based Antibiotics Global Market Outlook 2022-2028 - ResearchAndMarkets.com
2. Johnson & Johnson and Subsidiaries Consolidated Balance Sheets - Johnson & Johnson
3. Comprehensive Market Forecast for Doripenem: Market Analysis - OpenPR
4. FDA approves label changes for antibacterial Doribax (doripenem) - FDA
5. Shionogi: Global Perspective. Global Reach. - Shionogi Group