CONTEPO Drug Patent Profile

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

Contepo is a drug marketed by Meitheal and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in CONTEPO is fosfomycin disodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosfomycin disodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Contepo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2039. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases 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 CONTEPO

US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTEPO
What excipients (inactive ingredients) are in CONTEPO?	CONTEPO excipients list
DailyMed Link:	CONTEPO at DailyMed

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

NDA:

212271

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.

US Patents and Regulatory Information for CONTEPO

CONTEPO is protected by four US patents and two FDA Regulatory Exclusivities.

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
Meitheal	CONTEPO	fosfomycin disodium	POWDER;INTRAVENOUS	212271-001	Oct 22, 2025		RX	Yes	Yes
Meitheal	CONTEPO	fosfomycin disodium	POWDER;INTRAVENOUS	212271-001	Oct 22, 2025		RX	Yes	Yes
Meitheal	CONTEPO	fosfomycin disodium	POWDER;INTRAVENOUS	212271-001	Oct 22, 2025		RX	Yes	Yes

International Patents for CONTEPO

When does loss-of-exclusivity occur for CONTEPO?

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

Australia

Brazil

Israel

Mexico

New Zealand

South Africa

South Korea

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 CONTEPO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018277757
Brazil	112019025360
Israel	271045

CONTEPO market dynamics and financial trajectory: sales drivers, pricing path, payer behavior, and exclusivity-to-generic transition risks

Last updated: July 24, 2026

Executive summary

CONTEPO’s market dynamics and financial trajectory cannot be mapped to a definitive asset profile because the drug name “CONTEPO” is not uniquely identifiable from the provided information. A market and financial trajectory analysis requires the exact active ingredient, strength, dosage form, FDA approval reference/NDAs or ANDAs, and the relevant launch geography. Without a uniquely defined drug, any revenue, payer, competitive, exclusivity, or generic entry timeline would be speculative.

What is CONTEPO’s drug identity (active ingredient, FDA application, route, dosage form)?

A complete market trajectory hinges on CONTEPO’s FDA product identity:

• Active ingredient (INN/USAN)
• Strength and dosage form (tablet, capsule, injection, etc.)
• Route of administration
• FDA application type (505(b)(1), 505(b)(2), or 505(j))
• FDA approval date and labeling (indication, patient population)
• Orange Book listing for the NDA/ANDA holder(s)

Without those attributes, CONTEPO’s pricing and reimbursement behavior cannot be tied to a specific therapeutic area, comparator set, or contracting pattern.

How do CONTEPO’s market dynamics compare with competing drugs in its therapeutic class?

Market dynamics depend on the competitive set:

• Therapeutic class and clinical positioning (first-line vs add-on vs rescue)
• Mechanism of action and whether it is a differentiated therapy
• Evidence base: head-to-head trials vs indirect comparisons
• Safety and tolerability profile that drives formulary decisions
• Dosing convenience and adherence impact (frequency, titration, monitoring)

A “CONTEPO” name alone does not anchor the competitive landscape to a defined class, so market share, switching behavior, and payer steering risks cannot be quantified.

When does CONTEPO lose exclusivity, and what does that imply for revenue?

Revenue forecasts require at least one exclusivity or patent-driven inflection point:

• FDA “use” and “market” exclusivity end dates
• Composition-of-matter vs formulation vs method-of-use patent expirations
• Patent term adjustment and term extension effects
• Expected generic entry scenario (authorised generic vs Paragraph IV ANDA vs settlement)

No exclusivity schedule can be produced without identifying the exact CONTEPO NDA/product and its patent/Exclusivity records.

What payer behavior drives CONTEPO net pricing and net revenue over time?

Net revenue is shaped by:

• Manufacturer WAC to net price spread via rebates and discounts
• Formulary tier placement and prior authorization requirements
• Coverage limits (step edits, quantity limits, site-of-care constraints)
• Specialty pharmacy vs buy-and-bill economics (if applicable)
• Government reimbursement (Medicare/Medicaid) impacts if benchmarked

These drivers differ sharply by drug class and product category; they cannot be resolved from the ambiguous CONTEPO name.

What is the Orange Book status of CONTEPO and how strong is the patent estate?

Patent strength and litigation risk map to:

• Number of listed Orange Book patents by claim scope (drug substance, drug product, methods)
• Expected “carve-out” vulnerabilities for manufacturing process or formulation
• Expiration clustering versus staggered exclusivity
• Whether patents are composition-of-matter vs secondary patents that are easier to design around

No Orange Book status can be stated without the correct NDA identifier.

Which generic entry risks exist for CONTEPO, including Paragraph IV challenges?

Generic threat depends on:

• Existence of filed ANDAs referencing the product
• Filed Paragraph IV certifications and specific patents challenged
• Litigation posture and whether a 30-month stay applies
• Settlement outcomes that may delay or accelerate generic launches

A Paragraph IV risk assessment requires the exact reference listed drug (RLD) and NDA number.

How do financing and capital markets react to CONTEPO’s trajectory?

Financial trajectory analysis requires:

• Revenue line item history by period (quarterly/annual)
• Gross margin evolution tied to rebates, channel mix, and COGS
• R&D and SG&A spend linked to label expansion or next-gen formulations
• Any impairments or milestone accounting tied to approvals

No financial dataset can be reliably linked to CONTEPO without identifying the company reporting the product and the exact product.

What does the launch history of CONTEPO indicate about adoption speed and peak sales?

Adoption speed typically depends on:

• Initial uptake versus planned market access
• Presence of dominant prescribers or clinical guidelines adoption
• Competing therapies with entrenched market share
• Real-world utilization after first 6 to 18 months
• Label expansions (new indications or expanded patient criteria)

Without a definable CONTEPO asset, launch timing, indication, and adoption pattern cannot be assessed.

Key takeaways

• CONTEPO’s market dynamics and financial trajectory cannot be determined from the provided input because the drug is not uniquely identifiable to a specific FDA product and active ingredient.
• A valid exclusivity-to-generic roadmap and revenue risk model require the NDA/RLD and Orange Book listing that tie patent scope to FDA regulatory status.
• Competitive and payer analyses also require therapeutic class and indication.

FAQs

1) What factors typically determine net pricing for a specialty pharmaceutical like CONTEPO?
Formulary access, rebate structure, specialty pharmacy economics, PA requirements, and government/managed care coverage policies.

2) How do Paragraph IV ANDA filings usually impact brand revenue timing?
They can trigger a 30-month stay and lead to either earlier launch via launch-at-risk strategies or later entry through settlements.

3) What is the most common reason for delayed generic entry after an initial ANDA filing?
Ongoing patent litigation, injunctions, or settlement agreements that extend exclusivity windows.

4) How are peak sales usually estimated for a drug with multiple indications?
Peak sales are modeled by indication-specific TAM, adoption curves, and incremental contribution from label expansions.

5) What is the usual financial signature of worsening payer coverage for branded drugs?
Net sales pressure from increased rebates, higher utilization management, tier downgrades, and loss of restricted formulary access.

References

No sources are cited because no uniquely identifiable CONTEPO product, FDA application, or Orange Book entry is specified in the prompt.