PRIMAXIN Drug Patent Profile

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

Primaxin is a drug marketed by Merck and is included in three NDAs.

The generic ingredient in PRIMAXIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.

Summary for PRIMAXIN

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	2
Drug Prices:	Drug price information for PRIMAXIN
What excipients (inactive ingredients) are in PRIMAXIN?	PRIMAXIN excipients list
DailyMed Link:	PRIMAXIN at DailyMed

See drug prices for PRIMAXIN

Recent Clinical Trials for PRIMAXIN

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 1
Pfizer	Phase 3
AstraZeneca	Phase 3

See all PRIMAXIN clinical trials

Pharmacology for PRIMAXIN

Drug Class	Penem Antibacterial Renal Dehydropeptidase Inhibitor
Mechanism of Action	Dipeptidase Inhibitors

US Patents and Regulatory Information for PRIMAXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	INJECTABLE;INJECTION	062756-001	Jan 8, 1987		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	INJECTABLE;INJECTION	062756-002	Jan 8, 1987		DISCN	No	No

Expired US Patents for PRIMAXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990	5,147,868
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-002	Nov 26, 1985	5,147,868
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990	5,147,868

International Patents for PRIMAXIN

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

Country	Patent Number	Title	Estimated Expiration
Norway	150602
Poland	131618
Australia	4893279

Supplementary Protection Certificates for PRIMAXIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	C202030035	Spain		PRODUCT NAME: RELEBACTAM, OPCIONALMENTE EN FORMA DE MONOHIDRATO E IMIPENEM Y CILASTATINA; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF AUTHORISATION: 20200213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1420; DATE OF FIRST AUTHORISATION IN EEA: 20200213
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2666774	122020000036	Germany		PRODUCT NAME: RELEBACTAM, ODER RELEBACTAM IN FORM DES MONOHYDRATES, IMIPENEM UND CILASTATIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1420 20200213

PRIMAXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PRIMAXIN

Introduction

PRIMAXIN, a combination of imipenem and cilastatin, is a potent carbapenem antibiotic used to treat a wide range of bacterial infections. Understanding the market dynamics and financial trajectory of PRIMAXIN is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The imipenem market, which includes PRIMAXIN, has shown significant growth in recent years. As of 2019, the global imipenem market was valued at approximately USD 5.44 billion. This market is expected to grow further, with a projected Compound Annual Growth Rate (CAGR) of 24% from 2020 to 2027[4].

Indications and Usage

PRIMAXIN is indicated for the treatment of various infections, including urinary tract infections, intra-abdominal infections, gynecologic infections, bacterial septicemia, bone and joint infections, skin and skin structure infections, and endocarditis. Its broad spectrum of activity against both gram-positive and gram-negative bacteria contributes to its market demand[2].

Competitive Landscape

The antibiotic market is highly competitive, with several other carbapenems and broad-spectrum antibiotics available. However, PRIMAXIN's unique combination of imipenem and cilastatin, which prevents the renal metabolism of imipenem, sets it apart. This combination allows for higher urinary concentrations of imipenem, enhancing its efficacy against urinary tract infections[1][2].

Regulatory Environment

PRIMAXIN is regulated by stringent guidelines to ensure its safe and effective use. It is contraindicated in patients with hypersensitivity to any component of the drug and is not recommended for patients with meningitis or CNS infections due to the risk of seizures. These regulations impact its market dynamics by limiting its use in certain patient populations[2].

Pricing and Cost-Effectiveness

The cost of PRIMAXIN can be a significant factor in its market dynamics. A single vial of PRIMAXIN, containing 500 mg of imipenem and 500 mg of cilastatin, can be valued at around €6 in the Greek market, which is relatively affordable compared to other diagnostic methods for carbapenemase-producing bacteria[3].

Market Demand Drivers

Several factors drive the demand for PRIMAXIN:

• Increasing Incidence of Infections: The rising incidence of bacterial infections, particularly those caused by drug-resistant strains, increases the demand for effective antibiotics like PRIMAXIN.
• Hospital and Clinical Use: PRIMAXIN is widely used in hospitals and clinical settings due to its broad-spectrum activity and the need for effective treatment of severe infections.
• Lack of Alternative Treatments: For certain infections, PRIMAXIN may be one of the few effective treatment options, which can drive its demand despite its higher cost compared to some other antibiotics[2].

Financial Performance

The financial performance of PRIMAXIN is closely tied to the overall growth of the imipenem market. With a projected CAGR of 24%, the market is expected to expand significantly, contributing to increased revenue for pharmaceutical companies manufacturing PRIMAXIN. The market valuation and growth rate indicate a strong financial trajectory for this drug[4].

Challenges and Limitations

Despite its strong market position, PRIMAXIN faces several challenges:

• Resistance and Side Effects: The development of drug-resistant bacteria and the risk of side effects, such as seizures in patients with renal impairment, can impact its long-term market viability.
• Regulatory Restrictions: Limitations on its use in certain patient populations, such as those with CNS infections or impaired renal function, can restrict its market growth[1][2].

Future Outlook

The future outlook for PRIMAXIN remains positive due to its efficacy and the ongoing need for effective antibiotics. However, continuous monitoring of resistance patterns and side effects will be crucial. Additionally, advancements in diagnostic methods, such as the direct colorimetry of imipenem decomposition to detect carbapenemase-producing bacteria, could further enhance its market position[3].

Key Takeaways

• Market Growth: The imipenem market, including PRIMAXIN, is expected to grow significantly with a CAGR of 24% from 2020 to 2027.
• Broad Indications: PRIMAXIN is indicated for a wide range of bacterial infections, contributing to its market demand.
• Unique Mechanism: The combination of imipenem and cilastatin sets PRIMAXIN apart from other antibiotics.
• Regulatory Considerations: Strict regulations and contraindications impact its market dynamics.
• Financial Performance: The drug is expected to contribute significantly to the revenue of pharmaceutical companies due to its strong market position.

FAQs

What is PRIMAXIN used for?

PRIMAXIN is used to treat a variety of bacterial infections, including urinary tract infections, intra-abdominal infections, gynecologic infections, bacterial septicemia, bone and joint infections, skin and skin structure infections, and endocarditis[2].

What are the key components of PRIMAXIN?

PRIMAXIN consists of two components: imipenem, a carbapenem antibiotic, and cilastatin sodium, which inhibits the renal enzyme dehydropeptidase-I to prevent the metabolism of imipenem[1][2].

Why is PRIMAXIN not recommended for certain patient populations?

PRIMAXIN is not recommended for patients with meningitis or CNS infections due to the risk of seizures, and it is also not recommended for pediatric patients weighing less than 30 kg with impaired renal function[2].

How does the combination of imipenem and cilastatin enhance the efficacy of PRIMAXIN?

The combination allows for higher urinary concentrations of imipenem by preventing its renal metabolism, thus enhancing its efficacy against urinary tract infections[1][2].

What is the expected market growth for PRIMAXIN?

The imipenem market, including PRIMAXIN, is expected to grow with a CAGR of 24% from 2020 to 2027[4].

Sources

1. PRIMAXIN® - PDF, hres.ca
2. PRIMAXIN (imipenem and cilastatin) - accessdata.fda.gov
3. Direct colorimetry of imipenem decomposition as a novel cost-effective method for detecting carbapenemase production - biorxiv.org
4. Imipenem Market Demand & Growth, 2020-2027 - Reports and Data