Cilastatin sodium; imipenem - Generic Drug Details

What are the generic sources for cilastatin sodium; imipenem and what is the scope of patent protection?

Cilastatin sodium; imipenem is the generic ingredient in three branded drugs marketed by Merck, Acs Dobfar, Hospira Inc, Hq Spclt Pharma, and Msd Merck Co, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for cilastatin sodium; imipenem

US Patents:	1
Tradenames:	3
Applicants:	5
NDAs:	8
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
DailyMed Link:	cilastatin sodium; imipenem at DailyMed

Recent Clinical Trials for cilastatin sodium; imipenem

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 clinical trials

Pharmacology for cilastatin sodium; imipenem

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

US Patents and Regulatory Information for cilastatin sodium; imipenem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	090825-001	Nov 16, 2011		DISCN	No	No
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			Y	Y
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-002	Nov 26, 1985	AP	RX	Yes	Yes
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990		DISCN	No	No

Expired US Patents for cilastatin sodium; imipenem

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

Cilastatin sodium; imipenem Market Analysis and Financial Projection

Last updated: February 15, 2026

Market Dynamics for Cilastatin Sodium and Imipenem

Cilastatin sodium and imipenem are co-administered in the treatment of severe bacterial infections. Imipenem is a broad-spectrum carbapenem antibiotic, while cilastatin sodium inhibits renal dehydropeptidase-1, preventing imipenem degradation and enhancing its efficacy ([1]).

Market Drivers

• Rising antimicrobial resistance: The growth of multidrug-resistant bacteria favors the use of carbapenems like imipenem, boosting demand.
• Increase in healthcare-associated infections: Hospitals mandate potent antibiotics like imipenem for complicated infections.
• Expanding hospital network and advanced diagnostics: These facilitate early identification of severe infections, increasing scope for imipenem use.
• Limited antibiotics pipeline: Few new carbapenem alternatives restrict substitution options, sustaining imipenem’s market position ([2]).

Market Challenges

• Antimicrobial stewardship policies: Stricter regulations aim to curb overuse, limiting sales growth.
• Generic competition: Many imipenem formulations are off-patent, reducing prices significantly.
• Side-effect profile: Risks of seizures and hypersensitivity restrict use in some patient groups.

Market Trends

• Growth in Asia-Pacific: Rising healthcare expenditure and infection cases propel regional sales.
• Shift towards injectable formulations: Imipenem is primarily administered intravenously, limiting outpatient usage.
• Combination therapy preference: Use with other antibiotics for resistant infections increases demand for fixed-dose combinations.

Competitive Landscape

• Major players: Merck (as of 2023, product marketed as Primaxin), Schein (Mundipharma), and others produce generic imipenem-cilastatin.
• Patent expirations: Several formulations have gone off patent since 2010, intensifying price competition.
• Emerging biosimilars: No biosimilars exist for imipenem-cilastatin as of 2023, but generic options dominate.

Financial Trajectory

Revenue Estimates

• Global imipenem-cilastatin sales: Estimated at USD 1.2 billion in 2022 ([3]).
• Regional revenue breakdown:
  • North America: 40%
  • Europe: 25%
  • Asia-Pacific: 20%
  • Rest of the world: 15%

Growth Projections

• Compound Annual Growth Rate (CAGR): Forecasted at 4-5% globally from 2023 to 2028 ([4]).
• Factors influencing growth:
  • Increased use in emerging markets.
  • Regulatory approvals for new formulations or combination therapies.
  • Adoption in intensive care units and for multidrug-resistant infections.

Pricing Trends

• Price erosion: Generic competition has reduced the price of imipenem-cilastatin by approximately 30-50% since patent expiry.
• Reimbursement policies: Vary by region, with fluctuations affecting market size.
• Manufacturing costs: Relatively stable, with some reduction driven by optimization and scale.

Investment Outlook

• Research and Development: Limited pipeline, with few early-stage developments.
• Potential for new indications: Investigations into combination regimens for resistant pathogens could create market expansion.
• Regulatory landscape: Stringent approval processes influence entry of new formulations.

Conclusion

Imipenem-cilastatin remains a key antibiotic for severe bacterial infections, especially amid rising antimicrobial resistance. Market growth is steady but tempered by generic competition, stewardship policies, and pricing pressures. Emerging markets and potential new indications provide growth avenues.

Key Takeaways

• Market driven by antimicrobial resistance and hospital infection trends.
• Revenue growth forecast at 4-5% CAGR through 2028.
• Intense price competition from generics reduces margins.
• No biosimilar presence; generic options dominate.
• Regulatory and stewardship policies impact future sales potential.

FAQs

1. What are the primary indications for imipenem-cilastatin?
Used to treat complicated intra-abdominal, urinary tract, skin, and respiratory infections caused by multidrug-resistant bacteria.

2. How does antimicrobial resistance influence imipenem’s market?
Resistance increases demand for carbapenems like imipenem, but resistance development also threatens long-term efficacy.

3. Are there new formulations or combinations in development?
Limited pipeline; some research explores combinations with beta-lactamase inhibitors, but no major approvals reported as of 2023.

4. How does pricing affect the global market?
Generic competition has significantly lowered prices, especially outside North America and Europe, impacting revenue and profit margins.

5. What role do regulations play in market evolution?
Stewardship policies restrict overuse, potentially limiting growth but ensuring sustainable demand within approved indications.

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Sources:
[1] WHO. "Imipenem." 2021.
[2] MarketsandMarkets. "Antibiotics Market." 2022.
[3] IMS Health. "Global Antibiotics Sales." 2022.
[4] GlobalData. "Pharmaceutical Market Forecasts." 2023.