RECARBRIO Drug Patent Profile

Which patents cover Recarbrio, and what generic alternatives are available?

Recarbrio is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has seventy-four patent family members in thirty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Recarbrio

Recarbrio was eligible for patent challenges on July 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 16, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RECARBRIO

International Patents:	74
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for RECARBRIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECARBRIO
What excipients (inactive ingredients) are in RECARBRIO?	RECARBRIO excipients list
DailyMed Link:	RECARBRIO at DailyMed

See drug prices for RECARBRIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RECARBRIO

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

212819

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 RECARBRIO

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 4
Q2 Solutions	Phase 4
Indiana University Health Methodist Hospital	Phase 4

See all RECARBRIO clinical trials

Pharmacology for RECARBRIO

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

US Patents and Regulatory Information for RECARBRIO

RECARBRIO is protected by three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes

International Patents for RECARBRIO

When does loss-of-exclusivity occur for RECARBRIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

France

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RECARBRIO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009206119
Brazil	PI0906871
Canada	2712783
China	101918407
China	102827067
Colombia	6331438

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2231667	301050	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2666774	301052	Netherlands		PRODUCT NAME: RELEBACTAM, DESGEWENST IN DE VORM VAN HET MONOHYDRAAT, IMIPENEM EN CILASTATINE, DESGEWENST IN DE VORM VAN HET NATRIUMZOUT; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774	301051	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2231667	LUC00165	Luxembourg		PRODUCT NAME: RELEBACTAM, OU SON MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2231667	PA2020516	Lithuania		PRODUCT NAME: RELEBAKTAMAS ARBA JO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
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

Last updated: May 25, 2026

RECARBRIO market dynamics and financial trajectory (US revenue, pricing pressure, and exclusivity-driven risk)

Executive summary: RECARBRIO (imipenem, cilastatin, and relebactam; Merck) is a US hospital-focused, IV antibiotic with sales tied to inpatient demand cycles, formulary access, and carbapenem-replacement inertia rather than outpatient expansion. Revenue growth has been constrained by limited prescribing share versus older carbapenems and by rapid competitive responses from other broad-spectrum and beta-lactamase inhibitor regimens, including next-wave agents with differentiated spectra and contracting advantages. Financial trajectory is most sensitive to (i) time-to-formulary across large IDNs, (ii) CDI and culture-driven stewardship adoption, (iii) payer reimbursement and ASP compression during negotiated price cycles, and (iv) the pace of generic/authorized generic substitution risk at the molecule and formulation level as IP protection and regulatory exclusivities approach expiry windows.

---

What is RECARBRIO and how is it positioned in US hospital antibiotic purchasing?

RECARBRIO is an IV combination antibacterial indicated for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including in adults who have limited treatment options. Commercially, it competes inside a narrow inpatient utilization slice where empiric broad coverage and resistant Gram-negative coverage drive procurement decisions.

Positioning that matters in contracting:

• Stewardship fit: preference patterns in tertiary-care centers treating CRE- and ESBL-associated disease influence usage density.
• Payer mechanics: hospital acquisition cost and negotiated discounts determine formulary stickiness, not list price.
• Formulary adoption curve: national IDNs can grant restricted access, then expand after antibiogram and outcomes review.

Bottom line: RECARBRIO’s market dynamics are primarily driven by hospital formulary and antibiotic stewardship committees rather than outpatient volume.

---

How have RECARBRIO sales and market share evolved in the US?

Revenue trend drivers (practical):

1. Adoption lags after launch: inpatient antibiotics often take quarters to move from restricted to preferred status as pharmacy and therapeutics committees evaluate outcomes.
2. Utilization concentration: use clusters in high-acuity hospitals with high Gram-negative resistance prevalence and active infectious disease (ID) teams.
3. Contracting and ASP compression: as contracting expands beyond early adopters, negotiated net prices usually compress, muting top-line growth even when volume holds.
4. Inventory cycles: IV antibiotic demand can swing with staffing, bed occupancy, and seasonal infection patterns.

What to watch for in financial trajectory:

• Net sales growth vs. implied unit growth.
• Changes in ASP or average net price per dose after major IDN contracts.
• Whether usage shifts toward narrower indications (lower eligible patient pool) or broad empiric strategies (higher capture pool).

---

When does RECARBRIO lose exclusivity and how does that affect revenue risk?

Featured snippet answer: Revenue risk accelerates when market authorization pathways for generic imitations can enter before or at expiration of relevant regulatory exclusivities and listed patents.

Key exclusivity risk channels:

• Patent expiration (Orange Book listed patents): sets the legal entry window for generic manufacturers.
• Regulatory exclusivities (New Chemical Entity or New Molecular Entity): governs exclusivity for first applicant marketing approvals.
• Method-of-use exclusivity and additional regulatory protections: can extend commercial exclusivity if covered by distinct protected claims or pediatric exclusivity structures.

Financial impact mechanism:

• If exclusivity expires without enforceable follow-on patents, biosimilar-equivalent dynamics do not apply; generic entry still typically leads to steep ASP drops and volume reallocation within inpatient formularies.
• If follow-on patents remain enforceable, “pause-and-switch” behavior can delay substitution to the post-litigation window.

---

What patents protect RECARBRIO and how strong is the patent estate?

RECARBRIO’s patent estate strength typically determines whether generic entry is launched via Paragraph IV challenges and whether settlements delay effective substitution.

Patent estate components that affect litigation leverage:

• Composition-of-matter coverage on the active combination and/or specific salt forms.
• Formulation patents tied to stability, lyophilization, or IV delivery characteristics.
• Method-of-use patents tied to indications such as cIAI/cUTI populations.
• Manufacturing method patents affecting ability to produce a bioequivalent generic without design-around.

How “strength” maps to revenue trajectory:

• A strong estate with multiple staggered expiries creates a longer runway for Merck to retain pricing and formulary positions.
• Multiple independent claim sets that survive early invalidity motions can support a licensing or settlement structure that delays generic launch.

---

What generic entry risks exist for RECARBRIO under Paragraph IV?

Generic entry risk under Paragraph IV hinges on:

• Whether an ANDA has been filed (and for which strength/dosage forms).
• Whether the filing includes an explicit Paragraph IV certification for listed patents.
• Whether litigation has resulted in a settlement that carves out a delayed launch date.
• Whether courts have invalidated or narrowed key claims.

Commercial outcomes in the real world:

• If a settlement grants delayed entry, Merck’s net price often holds longer, and inventory ordering remains predictable.
• If a court decision clears the way earlier than expected, the volume shock is rapid as hospital formularies switch to lower net price options.

---

How does RECARBRIO compare with other carbapenem and beta-lactamase inhibitor antibiotics?

RECARBRIO competes in the same inpatient antibiotic category where differentiation is usually clinical outcomes plus contracting and availability.

Comparative competitive axes:

• Spectrum and resistance coverage for resistant Enterobacterales and healthcare-associated Gram-negative infections.
• Time-to-therapy and stewardship adoption patterns based on local antibiogram.
• Dosing convenience and IV administration characteristics that influence nursing workflow and dosing protocol adoption.
• Contracting leverage: hospitals often select a “preferred” within the category, and competing agents with better access can displace RECARBRIO even if clinical profiles are close.

Market dynamic implication: RECARBRIO growth is most vulnerable when competing drugs secure broader preferred status through system-wide contracts, especially at IDN scale.

---

What FDA status and regulatory milestones shape RECARBRIO’s commercial timeline?

FDA and commercial timeline linkages:

• Approval scope defines the eligible patient pool and drives how quickly uptake can scale.
• Label expansions can extend use into additional clinical contexts and support formulary expansion.
• Regulatory exclusivity affects when generic applicants can enter without marketing infringement risk.

Revenue trajectory sensitivity: label breadth changes are usually less frequent than contracting changes, so financial trajectory is typically driven more by purchasing patterns than by regulatory updates.

---

How do pricing, contracting, and hospital formularies influence RECARBRIO financial performance?

Key market mechanisms in inpatient antibiotic economics:

• Rebates and discounts shape net revenue more than list price.
• GPO and IDN negotiations often determine whether RECARBRIO is “preferred” or “restricted.”
• Formulary tiering drives prescribing habits for empiric therapy.

Implications for financial trajectory:

• Even if hospital demand grows, net sales can lag if net prices compress due to contract reopens or competitive bids.
• Conversely, if Merck secures preferred status in large systems, net price stability can preserve earnings through volume gains.

---

Which competitors are most likely to pressure RECARBRIO net sales?

In this therapeutic space, competitive pressure typically comes from:

• Next-generation beta-lactam/beta-lactamase inhibitor regimens with expanding IDN preference.
• Carbapenem alternatives with optimized spectrum and reduced use barriers.
• Resistance-targeted agents that match high-risk microbiology patterns in major hospitals.

How competitive dynamics show up in financials:

• Revenue declines often begin with restricted access reversals rather than immediate volume loss across all indications.
• Net price reductions can precede volume loss due to contracting re-optimization.

---

RECARBRIO revenue exposure by US lifecycle stage: what should management expect next?

Lifecycle stages and revenue behavior:

1. Adoption stage: incremental growth as restricted use becomes broader.
2. Maturity stage: growth flattens, and net price becomes the key variable.
3. Pre-expiry stage: late-cycle contracting can change net price forward.
4. Post-expiry / entry stage: ASP compression and rapid volume share transfer to generics if legal barriers fall.

RECARBRIO-specific sensitivity: market performance depends less on overall inpatient antibiotic market growth and more on whether Merck sustains preferred access through contracting while the patent estate remains enforceable.

---

How should investors underwrite RECARBRIO earnings under different exclusivity outcomes?

Scenario mapping:

• Favorable (patents sustain): Merck holds formulary preference, limiting net price erosion and delaying generic-driven volume substitution.
• Neutral (partial challenges / delayed launch): revenue may continue but at lower net price; margin compression can appear before a large volume drop.
• Adverse (early clearance / no settlement): generic entry triggers rapid net price decreases and volume reallocation.

Underwriting focus points:

• Contract renegotiation cadence with top IDNs.
• Whether usage remains in higher-resistance sites or drifts toward broader low-resistance populations.
• Degree of category preference and switching speed once a cheaper alternative enters.

---

Key Takeaways

• RECARBRIO’s market dynamics are dominated by US hospital contracting, stewardship adoption, and formulary tiering rather than outpatient expansion.
• Financial trajectory is shaped by a balance of (i) inpatient volume stability in high-resistance settings and (ii) negotiated net price trends driven by competitive bids and contract reopens.
• The primary revenue risk is exclusivity and patent-driven generic entry timing, including whether Paragraph IV filings lead to court wins or settlements that delay launch.
• Competitive pressure is most acute when alternative IV beta-lactamase inhibitor regimens secure preferred status at IDN scale, causing both net price erosion and prescribing shifts.

---

FAQs

What hospital systems drive the majority of RECARBRIO utilization?

Utilization concentrates in large IDN accounts with active stewardship programs and higher observed prevalence of resistant Gram-negative pathogens, where pharmacy and therapeutics committees evaluate RECARBRIO as a preferred restricted agent.

Does RECARBRIO face more pricing pressure from generics or from branded competitors?

In most inpatient antibiotic categories, branded competitor contracting pressure often drives earlier net price compression, while generic entry is the larger structural driver of volume share loss if it occurs.

How do formulary changes typically affect RECARBRIO sales quarter to quarter?

Formulary tiering shifts can create step-change impacts: restricted-to-preferred transitions usually lift utilization over successive quarters, while preferred-to-restricted reversals can reduce volume more quickly once protocols are updated.

What is the main stewardship driver for RECARBRIO prescribing in cIAI and cUTI?

Stewardship adoption tends to track microbiology patterns, antibiogram alignment, and clinician confidence in broad coverage for suspected resistant organisms, which is reinforced by local resistance trends and outcomes reviews.

How does patent litigation timing influence real-world net sales beyond the launch date?

Litigation can influence inventory purchasing behavior, contract reopen pacing, and whether hospitals hold or adjust therapy protocols, often causing net sales changes ahead of the generic launch window.

---

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drug Trials Snapshots. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
3. Merck. (n.d.). Investor relations and financial reporting. Merck & Co., Inc. https://www.merck.com/investors/

DrugChatter Q&A for RECARBRIO

Recarbrio imipenem cilastatin relebactam us market launch date?