MONOFERRIC Drug Patent Profile

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

Monoferric is a drug marketed by Pharmacosmos and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-three patent family members in twenty-five countries.

The generic ingredient in MONOFERRIC is ferric derisomaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric derisomaltose profile page.

DrugPatentWatch^® Generic Entry Outlook for Monoferric

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 25, 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 MONOFERRIC

International Patents:	63
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Drug Prices:	Drug price information for MONOFERRIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MONOFERRIC
What excipients (inactive ingredients) are in MONOFERRIC?	MONOFERRIC excipients list
DailyMed Link:	MONOFERRIC at DailyMed

See drug prices for MONOFERRIC

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

Constraining patent/regulatory exclusivity:

12,030,962

NDA:

208171

Dosage:

SOLUTION;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 MONOFERRIC

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

Sponsor	Phase
University of Saskatchewan	PHASE3
Oregon Health and Science University	Early Phase 1
Alberta Health Services, Calgary	Phase 3

See all MONOFERRIC clinical trials

US Patents and Regulatory Information for MONOFERRIC

MONOFERRIC is protected by five US patents.

This potential generic entry date is based on patent 12,030,962.

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
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	10,414,831		Y	Y

International Patents for MONOFERRIC

When does loss-of-exclusivity occur for MONOFERRIC?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

New Zealand

Philippines

Poland

Portugal

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 MONOFERRIC around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009342799
Brazil	PI0924653
Canada	2756580

Supplementary Protection Certificates for MONOFERRIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2411053	C02411053/01	Switzerland		PRODUCT NAME: FERRUM (III) UT FERRI ISOMALTOSIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67001 26.08.2019

MONOFERRIC (ferric derisomaltose) Market Dynamics and Financial Trajectory (Revenue, Pricing, Competition, and Patent-Driven Risk)

Last updated: July 28, 2026

What is Monoferric’s market position and revenue trajectory in iron deficiency anemia?

Monoferric (ferric derisomaltose; FDA: injectables) has competed in the intravenous (IV) iron deficiency anemia (IDA) segment where treatment speed, dosing convenience, and administered dose per visit drive clinician and payer selection. Market dynamics are shaped by three forces: (1) IV iron dosing schedules and maximum dose per infusion, (2) safety/tolerability and post-administration monitoring burden, and (3) formulary and contracting across hospital and outpatient infusion channels.

Competitive context. Monoferric’s main commercial rivals include older IV iron products (notably iron sucrose and ferric carboxymaltose) and newer IV iron alternatives in various geographies. Decision-making is often payer- and site-of-care specific because infusion center drug acquisition cost and administration workflow are priced differently than pharmacy benefit claims.

Financial trajectory drivers.

• Utilization expansion depends on guideline uptake for IV replacement in patients with poor oral response, intolerance, or need for rapid repletion.
• Channel mix (hospital outpatient vs inpatient vs clinic infusion) strongly affects realized net revenue due to rebates, distribution terms, and tendering.
• Contracting and switch rates depend on tender cycles, safety perceptions, and administration time.
• Switching risks rise when competitors gain favorable formulary placement or when procurement favors lower acquisition cost regardless of dosing convenience.

How do dosing schedule, infusion time, and administration convenience shape Monoferric’s market share?

In IV iron, dosing design impacts both throughput and costs per treated patient. Monoferric’s clinical positioning is typically anchored on ability to deliver larger single-visit doses under labeling, reducing the number of infusions versus regimens that require multiple shorter administrations.

Site-of-care economics.

• Fewer visits lower infusion chair time, nursing time, and observation overhead.
• Shorter administration pathways support higher patient throughput, which can be decisive in outpatient infusion centers.
• Supply reliability and distribution lead times affect tender outcomes.

What that means for share. Even when list price differs, procurement committees often compare “total treatment episode cost,” which bundles drug acquisition with administration workflow. Monoferric’s commercial performance has therefore been tied to how payers and providers price convenience and throughput, not only to per-mg acquisition.

What pricing and reimbursement dynamics affect Monoferric net revenue?

Net revenue is driven by reimbursement structure and contracting mechanics:

• Hospital and outpatient tendering: pricing is negotiated through group purchasing organizations and procurement contracts.
• Rebate intensity: depends on formulary status and whether volume commitments exist.
• ASP volatility: IV iron has pricing pressure because multiple products compete for the same infusions and procurement decisions can switch quickly between brands.

Realization pressure typically increases when:

• a competitor gains a broader formulary footprint in a hospital system;
• a tender bundles multiple IV iron products at a pooled discounted rate;
• biosafety or monitoring protocols are standardized across IV iron brands, reducing differentiation.

Which competitors are most likely to pressure Monoferric, and how does competition play out?

Monoferric competes in a crowded IV iron landscape. The most market-relevant competitive comparisons are against:

• Ferric carboxymaltose (strong competition in dosing convenience and fast repletion)
• Iron sucrose (dominant historically but often requires multiple administrations)
• Other IV iron formulations that gain traction via procurement or guideline reinforcement in specific indications

Competition mechanics in practice

• Formulary placement is often the biggest share driver. Once placed on formulary, switching can require new safety evidence, tighter tender pricing, or procurement renegotiation.
• Tender cycles can reset share quickly at contract renewal.
• Indication and patient subpopulations (chronic kidney disease, inflammatory bowel disease-related anemia, postpartum anemia, heart failure cohorts where IV iron use is common) can drive targeted adoption.

How do indication coverage and guideline use translate into demand for Monoferric?

Demand for IV iron is created by clinical need plus guideline adoption. Monoferric’s growth potential is tied to:

• expansion in label-relevant patient populations and care settings,
• clinician familiarity and trust in IV iron workflows,
• adoption in outpatient infusion with throughput constraints.

Key demand levers

• Physician preference: product selection in IDA often follows institutional experience and infusion protocols.
• Hospital pathways: standardized anemia pathways influence which IV iron is stocked and how orders are placed.
• Patient throughput targets: products enabling higher single-visit dosing can win contracts even with higher per-unit acquisition cost.

What is the patent and exclusivity landscape for Monoferric that shapes its financial trajectory?

Monoferric’s financial runway is governed by:

• composition-of-matter and formulation protection,
• method-of-use protection for IDA indications and specific dosing regimens (where claimed),
• exclusivity (if applicable to the specific jurisdiction and regulatory status),
• device/infusion protocol claims if present (less common for IV generics but sometimes relevant).

Commercial impact of the IP wall.

• If the patent estate is dense and includes formulation or dosing method claims, generic entry risk is reduced or delayed.
• If key claims are narrow or close to expiration, biosimilar-like substitution patterns can occur through “design-around” and litigation settlements.

When does Monoferric lose exclusivity, and what generic entry risks exist?

The market impact of exclusivity loss depends on:

• the jurisdiction (US vs EU vs UK),
• whether Orange Book-style listed patents exist for each relevant formulation/dosage,
• whether paragraph IV-style challenges are filed (US) or equivalent challenges occur in other jurisdictions,
• the settlement pattern (launch design-around, delayed launch date, or market-sharing).

Generic entry risk is highest when:

• the active substance has no broad method-of-use coverage remaining;
• formulation patents are weak or easy to design around;
• regulatory pathways allow rapid demonstration of bioequivalence/identity for complex IV iron products.

What Orange Book status applies to Monoferric in the US, and what patents are listed?

US market access and litigation timing typically hinge on the FDA Orange Book listings (for the specific brand, strengths, dosage forms, and manufacturer). The Orange Book determines which patents attach to the NDA and therefore which patents can be challenged via US-specific mechanisms.

How strong is the Monoferric patent estate against generic or biosimilar-style challenges?

Strength is evaluated via:

• claim breadth (composition vs process vs method-of-use),
• number of remaining active listed patents at each code,
• litigation history (if any) and how courts have treated similar IV iron patents,
• whether patents are vulnerable on obviousness or lack of written description/enabling disclosure.

Financial translation. A “thick” remaining estate tends to sustain price and volume retention and can support premium contracting. A thin estate increases the likelihood of price resets and faster volume migration to lower-cost entrants.

What patent litigation and settlement dynamics affect Monoferric revenue risk?

Litigation affects revenue through:

• entry delays via injunctions or settlement timing,
• switching behavior during litigation (some systems wait, others keep inventory),
• uncertainty discounts (providers may limit procurement of the challenged product near an expected entry date).

The practical revenue exposure is tied to:

• whether competitors can launch at risk if patents are not enjoined,
• how quickly payers and procurement systems switch post-launch.

What is the FDA regulatory status of Monoferric and how does it impact commercial scale-up?

Regulatory status influences:

• approved indications and dose administration frameworks,
• manufacturing scale readiness and batch release cadence,
• post-marketing requirements that can affect supply continuity and cost.

Commercial scale-up is constrained when:

• manufacturing capacity is limited relative to demand spikes,
• additional stability or manufacturing controls increase cost or slow release,
• label restrictions reduce real-world adoption.

How does Monoferric compare with ferric carboxymaltose and iron sucrose on market adoption and uptake?

From a business perspective, IV iron comparisons are usually reduced to three decision points:

• maximum dose per visit and implied number of administrations,
• safety monitoring burden and infusion center workflow,
• payer contracting preference and realized net price.

Typical pattern in adoption:

• multi-infusion regimens face switch pressure where single-visit dosing is valued,
• brands with better contracting outcomes can outperform even if perceived clinical advantages are similar.

What formulation and manufacturing/IP barriers could block or slow generic competition for Monoferric?

For complex IV iron products, barriers can include:

• manufacturing process controls tied to specific complex formation or stability profiles,
• specification windows and impurity profiles,
• need for consistent particle/complex characteristics,
• analytical comparability requirements that increase development cost and time.

Effect on financial trajectory. Higher development friction tends to delay entry and reduce the number of competitors that can successfully launch, sustaining pricing power longer.

How do channel strategy and distribution structure affect Monoferric sales stability?

IV iron sales often correlate with distribution relationships and tender execution:

• hospital group purchasing agreements can dominate volumes,
• outpatient infusion centers have faster switching but also more frequent tender turnover,
• supply chain disruptions can temporarily reduce fill and create short-term revenue volatility.

Stability factors

• multi-site contracting reduces customer churn,
• strong hospital pharmacy and infusion pharmacy relationships improve ordering consistency,
• reliable lead time reduces stockouts and avoids missed treatment cycles.

Key commercial timeline: what milestones typically move Monoferric revenue?

Monoferric’s financial path is generally moved by:

• label expansions that widen eligible patient populations,
• formulary placements in large hospital networks,
• tender awards or renewals in major procurement groups,
• competitive launches that reset acquisition economics,
• IP expiration or litigation outcomes that change expected switching timing.

(Note: the precise milestone dates and revenue figures for Monoferric are jurisdiction- and period-specific and must be sourced from the company’s financial disclosures and regulator/Orange Book records.)

Key Takeaways

• Monoferric’s market dynamics are primarily driven by IV iron contracting economics tied to dosing convenience, visit count, and infusion-center throughput.
• Net revenue is sensitive to hospital tendering cycles, rebate intensity, and channel mix between inpatient and outpatient infusion.
• Competitive pressure is centered on ferric carboxymaltose and other IV iron formulations that can match workflow needs or win procurement pricing.
• Financial trajectory risk increases as patent and exclusivity protections narrow and as generic entry timing becomes predictable via regulatory listings and litigation outcomes.

FAQs

1. What factors most influence IV iron procurement decisions in hospital outpatient settings?
2. How do FDA regulatory status and labeling changes affect Monoferric real-world adoption?
3. What Orange Book patent listings determine whether a generic can file a US paragraph IV challenge to Monoferric?
4. Which patient subgroups drive the highest incremental demand for IV iron products like Monoferric?
5. How does tender timing affect switching risk and near-term revenue for IV iron brands?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Approval Reports and Drug Trials Snapshots (for approved products and regulatory history). https://www.fda.gov/drugs/development-approval-process-drugs/
3. FDA. Access data for labeling and drug approval information. https://www.accessdata.fda.gov/

DrugChatter Q&A for MONOFERRIC

When did monoferric get approved in canada and when does the patent expire?
What are the name of the biosimilar of monoferric?
Monoferric biosimilar name?
Monoferric iron vs venofer?