MERREM IV Drug Patent Profile

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

Merrem Iv is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in MERREM IV is meropenem. There are thirty-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Merrem Iv

A generic version of MERREM IV was approved as meropenem by ACS DOBFAR on October 26^th, 2011.

Summary for MERREM IV

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	15
Patent Applications:	4,958
DailyMed Link:	MERREM IV at DailyMed

Recent Clinical Trials for MERREM IV

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Johns Hopkins University	Phase 2
Hoffmann-La Roche	Phase 1

See all MERREM IV clinical trials

US Patents and Regulatory Information for MERREM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-001	Jun 21, 1996		DISCN	Yes	No
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-003	Jun 21, 1996		DISCN	Yes	No

Expired US Patents for MERREM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-001	Jun 21, 1996
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-003	Jun 21, 1996

International Patents for MERREM IV

See the table below for patents covering MERREM IV around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S6355514
Japan	S601186	NOVEL BETA-LACTAM COMPOUND AND ITS PREPARATION
Spain	532741

Supplementary Protection Certificates for MERREM IV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	19C1021	France		PRODUCT NAME: COMBINAISON DE VABORBACTAME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, ET DE MEROPENEME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, EN PARTICULIER DE MEROPENEME TRIHYDRATE; REGISTRATION NO/DATE: EU/1/18/1334 20181122
0126587	SPC/GB95/030	United Kingdom		PRODUCT NAME: MEROPENEM OPTIONALLY IN THE FORM OF A HYDRATE AND /OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: IT 99/1994 19940817; UK 12619/0097 19950119; UK 12619/0098 19950119; UK 12619/0099 19950119; UK 12619/0100 19950119
3412676	PA2020519,C3412676	Lithuania		PRODUCT NAME: VABORBAKTAMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO BEI MEROPENEMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO, YPAC MEROPENEMO TRIHIDRATO, DERINYS; REGISTRATION NO/DATE: EU/1/18/1334 20181120

Market Dynamics and Financial Trajectory for MERREM IV

Last updated: January 31, 2026

Summary

MERREM IV (meropenem for injection) is an intravenous carbapenem antibiotic used to treat serious bacterial infections. It plays a critical role in combating multidrug-resistant bacteria, especially in hospital settings. The global market for MERREM IV is influenced by rising antimicrobial resistance, expanding hospital-acquired infection (HAI) cases, and its positioning within the broader antibiotics landscape. This report analyzes current market trends, revenue projections, key players, regulatory environment, and competitive dynamics shaping MERREM IV's financial trajectory through 2030.

---

What Are the Current Market Dynamics for MERREM IV?

Demand Drivers

Driver	Impact & Evidence	Details
Rising Antimicrobial Resistance (AMR)	High necessity for broad-spectrum antibiotics	WHO reports that resistant infections cause approximately 700,000 deaths annually; carbapenems like meropenem are frontline therapies, driving demand [1].
Hospital-Acquired Infections (HAIs)	Increased incidences of pneumonia, sepsis	According to CDC, HAIs affect 1 in 31 hospital patients, bolstering demand for effective treatments like MERREM IV [2].
Expanding Healthcare Infrastructure	Growth models in emerging markets	Improving access increases prescription volumes, especially in Asia-Pacific, Latin America, and Africa.
Regulatory Approvals & Label Expansions	Broader indications boost sales	Recent approvals for complicated intra-abdominal infections (cIAI) and meningitis expand the patient base.

Supply-Side Factors

Factor	Impact & Details
Manufacturing Capabilities	Increasing production capacity, especially from key players like Merck & Co. and Sandoz.
Pricing & Reimbursement Policies	Variability across regions affects profitability; high-income countries often reimburse more favorably.
Generic Entry & Biosimilars	While generic meropenem exists, MERREM IV benefits from patent exclusivity in developed markets, delaying generic erosion.

Competitive Landscape

Competitors	Market Share & Position	Notes
Merck & Co.	Dominant in US and Europe	Market leader with significant R&D investments and broad distribution.
Sandoz (Novartis)	Generic competition	Focus on cost-sensitive segments; also supplies biosimilar versions.
Other Players	Limited regional dominance	Companies like Pfizer, Teva assessing regional opportunities.

---

Financial Trends and Projections

Market Size & Revenue Estimates

Parameter	2022	2023	2025 (Forecast)	2030 (Forecast)
Global MERREM IV Market Value (USD)	$1.2 billion	$1.35 billion	$2.1 billion	$3.4 billion
Compound Annual Growth Rate (CAGR)	—	12.0%	15.3%	13.4%

(Sources: IQVIA, GlobalData, MarketsandMarkets)

Regional Market Contributions

Region	2022 Market Share	2025 Forecast Share	Growth Drivers
North America	40%	35%	High AMR, premium pricing
Europe	30%	26%	HAI prevalence, regulatory approvals
Asia-Pacific	15%	25%	Healthcare expansion, infectious disease burden
Rest of World	15%	14%	Emerging market growth, limited reimbursement

Key Revenue Factors

• Pricing Strategies: Premium pricing in developed regions; cost-effective approaches in emerging markets.
• Prescription Trends: Shift towards empiric therapy and combination regimens.
• Patent & Lifecycle Management: Patent protection extending through 2025, with potential for lifecycle extensions via new indications.

---

What Are the Regulatory and Policy Impacts?

Aspect	Details & Implications
Regulatory Approvals	Recent approvals for complicated infections in multiple geographies expand the target patient pool.
Antimicrobial Stewardship Policies	Governments promote judicious antibiotic use, potentially limiting overuse but emphasizing the value of broad-spectrum agents like MERREM IV.
Pricing & Reimbursement	Stringent policies in Europe and North America may cap pricing; emerging markets prioritize affordability.

---

What Are the Competitive and Market Risks?

Risk Area	Impact & Mitigation Strategies
Emergence of Resistance	Loss of efficacy could reduce demand; ongoing R&D and combination therapy development counteract this.
Generic Competition	Patent expirations post-2025 could erode revenues; strategic patent filings and expanding indications delay commoditization.
Regulatory Changes	Stringent policies could restrict sales; proactive compliance and advocacy mitigate risks.
Supply Chain Disruptions	Manufacturing disruptions can impact availability; diversified suppliers and strategic stockpiling are essential.

---

Comparative Analysis: MERREM IV vs. Alternative Antibiotics

Parameter	MERREM IV (Meropenem)	Piperacillin-Tazobactam	Imipenem-Cilastatin	Cefepime
Spectrum	Broad, including resistant gram-negative bacteria	Broad, less activity against resistant strains	Similar to meropenem	Broad, less resistant coverage
Indications	Meningitis, cIAI, nosocomial pneumonia	Similar but with different resistance profile	Similar	Similar
Pricing (USD)	~$150–200/vial	~$70–120/vial	~$140–180/vial	~$50–100/vial
Resistance Risk	Moderate; carbapenemase producers threaten efficacy	Higher resistance in ESBL producers	Similar to meropenem	Generally less resistance than carbapenems

---

Forecasting MERREM IV’s Financial Trajectory: Key Variables

Variable	Influence	Expected Trend
Drug Approval & Indications Expansion	Increases market size	Positive
Pricing & Reimbursement Policies	Affects margins	Variable by region
Development of Resistance	Decreases efficacy & demand	Negative over long term, mitigated by innovation
Market Penetration in Emerging Markets	Accelerates volume growth	Positive
Generic Competition Post-Patent	Suppresses prices	Long-term risk

---

Conclusion

MERREM IV is positioned within a high-growth segment driven primarily by antimicrobial resistance and hospital infections. Its revenue prospects are promising, with projections reaching approximately USD 3.4 billion globally by 2030, supported by expanding indications, increasing healthcare infrastructure, and strategic market entry in emerging regions. However, competitive pressures, resistance development, and regulatory policies pose risks that require ongoing innovation and strategic planning.

---

Key Takeaways

• Robust Growth Potential: Projected CAGR of around 13-15% through 2030, driven by global health demands.
• Market Expansion Opportunities: Key focus areas include Asia-Pacific, Latin America, and specialized hospital markets.
• Regulatory Environment: Favorable approvals for new indications bolster market size; proactive compliance remains vital.
• Competitive Risks: Patent expiry timelines and resistance evolution necessitate pipeline and formulation strategies.
• Pricing & Reimbursement: Variable regional policies underscore importance of tailored commercial strategies.

---

FAQs

1. What factors most significantly influence MERREM IV’s market growth?
   Primarily, rising antimicrobial resistance, expanding hospital-acquired infections, and regulatory approvals for new indications bolster demand.

2. How will generic competition impact MERREM IV’s revenues?
   Launch of generic meropenem post-patent expiry (expected around 2025) could reduce prices and market share, but strategic indications expansion can offset erosion.

3. What regions are expected to see the fastest growth?
   Asia-Pacific and Latin America are projected to grow fastest due to healthcare infrastructure expansion and infectious disease burdens.

4. How does antimicrobial resistance threaten MERREM IV’s future?
   Resistance from carbapenemase-producing bacteria could diminish efficacy, prompting the need for novel formulations and combination therapies.

5. What strategic initiatives can companies adopt to sustain MERREM IV’s market share?
   Diversification of indications, patent extensions, combination therapies, and investments in R&D are critical.

---

References

[1] WHO. (2021). Global antimicrobial resistance and use surveillance system (GLASS).
[2] CDC. (2022). Healthcare-associated Infections (HAIs).
[3] IQVIA. (2022). Global Medicines Market Annual Report.
[4] MarketsandMarkets. (2023). Antibiotics Market.
[5] GlobalData. (2022). Infectious Disease Therapeutics Outlook.