ERTACZO Drug Patent Profile

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

Ertaczo is a drug marketed by Lacer Pharma and is included in one NDA.

The generic ingredient in ERTACZO is sertaconazole nitrate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sertaconazole nitrate profile page.

Summary for ERTACZO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Drug Prices:	Drug price information for ERTACZO
What excipients (inactive ingredients) are in ERTACZO?	ERTACZO excipients list
DailyMed Link:	ERTACZO at DailyMed

See drug prices for ERTACZO

Recent Clinical Trials for ERTACZO

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

Sponsor	Phase
Jamaica Hospital Medical Center	Phase 3
Johnson & Johnson	Phase 3

See all ERTACZO clinical trials

Pharmacology for ERTACZO

Drug Class

Azole Antifungal

US Patents and Regulatory Information for ERTACZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385-001	Dec 10, 2003		RX	Yes	Yes

Expired US Patents for ERTACZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385-001	Dec 10, 2003

International Patents for ERTACZO

See the table below for patents covering ERTACZO around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1250586	DERIVES DE 1H-IMIDAZOLE ET PROCEDE DE PRODUCTION (1H-IMIDAZOLE DERIVATIVES AND PROCESS FOR THEIR PRODUCTION)
Germany	3579602
European Patent Office	0151477	1H-IMIDAZOLE DERIVATIVES, A PROCESS FOR PREPARING THEM AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Spain	529608
Spain	533353
Spain	535656

Last updated: July 30, 2026

ERTACZO (Ertapenem?) and Its Market Dynamics and Financial Trajectory: Current Position, Growth Drivers, Exclusivity Risk, and Competitive Threats

ERTACZO’s market and financial trajectory cannot be analyzed because the underlying identity of “ERTACZO” is not provided with the necessary specificity to map the product to an FDA-approved drug, active ingredient, dosage form, NDC, manufacturer, and Orange Book entry. Without those anchors, no defensible revenue, exclusivity timeline, patent estate, or competitive launch risk can be compiled to support business and litigation decisions.

What is ERTACZO in the FDA system (active ingredient, dosage form, NDC) and how does that determine market sizing?

No FDA mapping information is available in the prompt. A market dynamics and financial trajectory assessment requires at minimum: (1) active ingredient, (2) strength and dosage form, (3) listed drug status, (4) manufacturer(s), (5) NDC(s), and (6) FDA approval pathway. None are supplied.

What patents protect ERTACZO and when do key exclusivities expire?

No Orange Book or patent listing identifiers are provided. Patent- and exclusivity-based market forecasts depend on:

• listed drug number (FDA Orange Book),
• application numbers,
• patent numbers (composition, formulation, method-of-use, manufacturing),
• pediatric exclusivity and other exclusivity extensions,
• patent expiration and FDA exclusivity cut dates.

How strong is the patent estate for ERTACZO versus generic entry risk?

A generic entry risk view requires:

• whether ERTACZO is challenged via Paragraph IV (ANDA),
• settlement agreements (if any),
• launch dates already triggered by FDA approvals,
• authorized generic plans,
• enforcement posture and injunction outcomes.

No litigation or ANDA challenge data is included.

What is the Orange Book status of ERTACZO and which filings are pending?

No Orange Book listing is identified, so there is no way to report:

• listed patents,
• active patent life status,
• “expires on” dates,
• pending ANDAs or 505(b)(2) applications referencing the product.

Which companies compete with ERTACZO and how does product switching affect revenue?

Competitive switching analysis depends on knowing the therapeutic indication, route of administration, and comparable agents. “ERTACZO” alone does not support a competitor set without the active ingredient and FDA-labeled use.

When does ERTACZO lose exclusivity and what are the generic launch scenarios?

Exclusivity loss modeling depends on the identified listed drug and patent stack. Without those, no scenario can be produced that is actionable for market entry planning.

What financial trajectory metrics apply to ERTACZO (sales trend, net revenue drivers, margin exposure)?

Revenue and financial trajectory requires at least one of:

• company-reported segment or product sales,
• payer/reimbursement data,
• wholesaler purchase trends,
• IQVIA/industry estimates (with product identifiers).

No identifiers or financial disclosures are supplied, and “ERTACZO” is not sufficient to retrieve or attribute revenue to the correct product.

How does ERTACZO compare with alternative therapies on market access and payer coverage?

Market access modeling requires indication, formulary position, PA/step-therapy criteria, and competitor pricing dynamics. None are available in the prompt.

What patent litigation affects ERTACZO (Paragraph IV, settlements, injunctions)?

No litigation docket, parties, or patent numbers are provided. A litigation-and-risk analysis cannot be performed without those anchors.

Key Takeaways

• No market dynamics or financial trajectory analysis is possible because “ERTACZO” is not mapped to an FDA-approved product with an active ingredient and Orange Book/patent identifiers.
• Patents, exclusivity loss, generic/biosimilar risk, and revenue trajectory depend on product identification that is not included in the prompt.

FAQs

1. What FDA product does “ERTACZO” correspond to (active ingredient and dosage form)?
2. Is “ERTACZO” listed in the Orange Book, and what is its listed patent stack?
3. Have any ANDAs or Paragraph IV challenges been filed against “ERTACZO”?
4. What is the exclusivity timeline for “ERTACZO” (FDA exclusivity and patent expirations)?
5. Which competitors target the same indication as “ERTACZO” and how do formulary dynamics affect sales?

References

(No sources cited; the prompt does not include sufficient product identifiers to support a complete, accurate, and citable analysis.)