CILASTATIN SODIUM; IMIPENEM; RELEBACTAM - Generic Drug Details

What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of freedom to operate?

Cilastatin sodium; imipenem; relebactam is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Cilastatin sodium; imipenem; relebactam has seventy-one patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

International Patents:	71
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	CILASTATIN SODIUM; IMIPENEM; RELEBACTAM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Merck Sharp & Dohme Corp.	Phase 3

See all CILASTATIN SODIUM; IMIPENEM; RELEBACTAM clinical trials

Pharmacology for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

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

US Patents and Regulatory Information for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes			Y	Y
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes

International Patents for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Country	Patent Number	Title	Estimated Expiration
South Africa	201005333	BETA-LACTAMASE INHIBITORS
Cyprus	1114900
Cyprus	2020025
Slovenia	2231667
Cyprus	1116243
France	20C1030

Supplementary Protection Certificates for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2231667	122020000034	Germany		PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/19/1420 20200213; FIRST REGISTRATION: EU EU/1/191420 20200213
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
2666774	132020000000073	Italy		PRODUCT NAME: RELEBACTAM, OPZIONALMENTE IN FORMA DEL MONOIDRATO, IMIPENEM E CILASTATINA, OPZIONALMENTE NELLA FORMA DEL SALE SODICO(RECARBRIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1420, 20200217
2666774	31/2020	Austria		PRODUCT NAME: RELEBACTAM, GEGEBENENFALLS IN DER FORM DES MONOHYDRATS, IMIPENEM UND CILASTATIN, GEGEBENENFALLS IN DER FORM DES NATRIUMSALZES.; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217
2666774	2020C/524	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2231667	2090030-4	Sweden		PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REG. NO/DATE: EU/1/19/1420 20200217

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Imipenem/Cilastatin/Relebactam

Introduction to Imipenem/Cilastatin/Relebactam

Imipenem/cilastatin/relebactam, a combination of the carbapenem antibiotic imipenem, the dehydropeptidase inhibitor cilastatin, and the beta-lactamase inhibitor relebactam, has emerged as a significant player in the treatment of complicated Gram-negative bacterial infections. This combination, marketed as Recarbrio, has shown promising results in clinical trials and has been approved for various indications.

Clinical Efficacy and Safety

The clinical efficacy of imipenem/cilastatin/relebactam has been demonstrated in several pivotal Phase 3 studies. The RESTORE-IMI 1 trial showed that this combination had a favorable overall response against imipenem-non-susceptible bacterial infections, with lower treatment-emergent nephrotoxicity compared to a colistin plus imipenem regimen[1][5].

In another study, imipenem/cilastatin/relebactam was found to be non-inferior to piperacillin/tazobactam for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia[1][5].

Regulatory Status

The U.S. Food and Drug Administration (FDA) has designated imipenem/cilastatin/relebactam as a Qualified Infectious Disease Product (QIDP) with Fast Track status for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infections[1][5].

Market Need and Demand

The increasing prevalence of carbapenem-resistant Gram-negative pathogens has created a significant market need for effective new antibacterial agents. As Dr. Amanda Paschke from Merck Research Laboratories noted, "Infections caused by Gram-negative bacteria continue to be a major problem for hospitalized patients," highlighting the urgent need for drugs like imipenem/cilastatin/relebactam[1].

Cost-Effectiveness

Several studies have evaluated the cost-effectiveness of imipenem/cilastatin/relebactam. One study compared the cost-effectiveness of this combination versus colistin plus imipenem for treating infections caused by carbapenem-non-susceptible Gram-negative pathogens. The results indicated that imipenem/cilastatin/relebactam generated more quality-adjusted life years (QALYs) at an increased cost, but the incremental cost-effectiveness ratio was below the typical U.S. willingness-to-pay threshold[2][4].

Another study focused on the cost-effectiveness for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, showing that early adjustment to imipenem/cilastatin/relebactam from empiric piperacillin/tazobactam was cost-effective, with an incremental cost-effectiveness ratio of $17,529 per QALY[4].

Financial Trajectory

Given its clinical efficacy, regulatory approvals, and cost-effectiveness, the financial trajectory for imipenem/cilastatin/relebactam is promising. Here are some key financial aspects:

Revenue Potential

The approval and adoption of imipenem/cilastatin/relebactam in various markets are expected to drive significant revenue for Merck. The drug's ability to treat serious and resistant infections positions it as a valuable asset in the pharmaceutical market.

Market Share

As the drug gains more acceptance and usage in clinical settings, it is likely to capture a substantial market share in the segment of antibiotics targeting Gram-negative bacterial infections.

Pricing Strategy

The pricing of imipenem/cilastatin/relebactam will be influenced by its cost-effectiveness and the value it brings to patients and healthcare systems. Given its favorable cost-effectiveness ratios, the drug is likely to be priced competitively to ensure widespread adoption.

Competitive Landscape

The antibiotic market is highly competitive, but imipenem/cilastatin/relebactam's unique profile and approvals for specific indications give it a competitive edge. It will compete with other antibiotics like piperacillin/tazobactam and colistin-based regimens, but its lower nephrotoxicity and broader spectrum of activity are significant differentiators[1][5].

Future Outlook

The future outlook for imipenem/cilastatin/relebactam is positive, driven by several factors:

Ongoing Clinical Trials

Merck is conducting additional clinical trials to further establish the efficacy and safety of this combination. The RESTORE-IMI 2 trial, for example, is comparing imipenem/cilastatin/relebactam to piperacillin/tazobactam in patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia[1].

Expanding Indications

There is potential for imipenem/cilastatin/relebactam to be approved for additional indications, further expanding its market reach.

Global Health Impact

The drug's ability to combat multidrug-resistant Gram-negative infections makes it a crucial tool in the global fight against antibiotic resistance.

Key Takeaways

• Clinical Efficacy: Imipenem/cilastatin/relebactam has demonstrated favorable outcomes against imipenem-non-susceptible bacterial infections with lower nephrotoxicity.
• Regulatory Approvals: The combination has been approved for various indications and has QIDP and Fast Track status.
• Cost-Effectiveness: Studies show that imipenem/cilastatin/relebactam is cost-effective compared to other treatment options.
• Market Potential: The drug has significant revenue potential due to its unique profile and market need.
• Future Outlook: Ongoing trials and potential for expanded indications suggest a bright future for this antibiotic combination.

FAQs

Q: What is imipenem/cilastatin/relebactam used for? A: Imipenem/cilastatin/relebactam is used for the treatment of complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia caused by Gram-negative bacteria.

Q: How does relebactam enhance the efficacy of imipenem? A: Relebactam is a beta-lactamase inhibitor that prevents the breakdown of imipenem by beta-lactamases, thereby extending its antibacterial activity against resistant pathogens[1][5].

Q: What are the common adverse events associated with imipenem/cilastatin/relebactam? A: Common adverse events include anemia, elevated liver enzymes, electrolyte imbalances, nausea, vomiting, diarrhea, headache, fever, phlebitis, and infusion-site reactions[5].

Q: Is imipenem/cilastatin/relebactam cost-effective? A: Yes, studies have shown that imipenem/cilastatin/relebactam is cost-effective compared to other treatment options, generating more QALYs at an acceptable incremental cost[2][4].

Q: What is the regulatory status of imipenem/cilastatin/relebactam? A: The combination has been approved by the FDA and has been designated as a QIDP with Fast Track status for several indications[1][5].

Sources

1. Merck Press Release: Pivotal Phase 3 Study of Merck's Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections[1].
2. PubMed: Cost-Effectiveness of Imipenem/Cilastatin/Relebactam Compared to Colistin Plus Imipenem for the Treatment of Infections Caused by Confirmed CNS Pathogens[2].
3. European Medicines Agency: Recarbrio[3].
4. PubMed: Cost-effectiveness of imipenem/cilastatin/relebactam for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia[4].
5. American Journal of Health-System Pharmacy: Imipenem/cilastatin/relebactam: A new carbapenem β-lactamase inhibitor combination[5].