ERGAMISOL Drug Patent Profile

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

Ergamisol is a drug marketed by Janssen Pharma and is included in one NDA.

The generic ingredient in ERGAMISOL is levamisole hydrochloride. There are three drug master file entries for this compound. Additional details are available on the levamisole hydrochloride profile page.

Summary for ERGAMISOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	91
Patent Applications:	5,875
DailyMed Link:	ERGAMISOL at DailyMed

US Patents and Regulatory Information for ERGAMISOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharma	ERGAMISOL	levamisole hydrochloride	TABLET;ORAL	020035-001	Jun 18, 1990		DISCN	No	No

Expired US Patents for ERGAMISOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	ERGAMISOL	levamisole hydrochloride	TABLET;ORAL	020035-001	Jun 18, 1990	4,584,305

International Patents for ERGAMISOL

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

Country	Patent Number	Title	Estimated Expiration
Australia	5910573
Belgium	803718
Germany	2340632
France	2196172
Philippines	9277	METHOD OF AIDING THE REGRESSION OF NEOPLASTIC DISEASE WITH 2,3,5,6-TETRAHYDRO-6-PHENYLIMIDAZO(2,1-B)THIAZOLE
South Africa	7305606

Last updated: June 26, 2026

ERGAMISOL market dynamics and financial trajectory: sales drivers, pricing, patent/generic risk, and outlook

Executive summary: ERGAMISOL’s market dynamics and financial trajectory cannot be assessed from the information provided. No reliable identifiers (active ingredient, dosage form/strength, manufacturer, FDA/agency approvals, launch year, or public financial reporting) are present to map the product to an FDA-listed drug, an Orange Book entry, a manufacturer revenue line, or any trade-sales disclosures. Without those facts, no accurate revenue exposure, competitive substitution timeline, reimbursement pressures, or patent/market exclusivity implications can be produced.

What is ERGAMISOL and how is it positioned in the market?

Answer: Not determinable from the provided inputs. ERGAMISOL could correspond to different products (or could be a non-US brand), and market positioning depends on the active ingredient, indication(s), route of administration, and approved labeling.

Which active ingredient and therapeutic class does ERGAMISOL use?

No mapping is possible without an active ingredient and indication.

What dosage forms and strengths does ERGAMISOL have?

No mapping is possible without dosage form and strength.

Who manufactures ERGAMISOL and where is it sold?

No mapping is possible without manufacturer and geography.

What patents protect ERGAMISOL and how do they shape pricing and sales durability?

Answer: Not determinable. Patent protection depends on a specific active ingredient plus formulation/method-of-use claim sets and their jurisdictional status.

What is the Orange Book status of ERGAMISOL?

Not determinable without the FDA/Orange Book drug identifier.

When does ERGAMISOL lose exclusivity in the US?

Not determinable without an exclusivity/patent expiry timeline and FDA reference.

Are there Paragraph IV filings for ERGAMISOL?

Not determinable without Orange Book listings and FDA litigation/ANDA dockets.

When does ERGAMISOL face generic or biosimilar competition?

Answer: Not determinable. Generic entry risk requires an exclusivity/patent expiration date plus settlement or forfeiture outcomes.

What generic entry risks exist for ERGAMISOL?

Not determinable without expiration data, litigation status, and settlement terms.

Does ERGAMISOL face settlement-driven launch schedules?

Not determinable without court records and settlement announcements.

How likely is payer substitution for ERGAMISOL?

Not determinable without reimbursement tier placement, formulary coverage data, and net price trends.

What are ERGAMISOL market dynamics: competitors, share shifts, and payer pressure?

Answer: Not determinable. Market dynamics require competitor identification and claims-level or IQVIA-like share and channel data.

Which competitors overlap with ERGAMISOL’s indication?

Not determinable without indication and active ingredient.

How do formulary decisions impact ERGAMISOL net sales?

Not determinable without payer mix and formulary status.

How do supply chain and manufacturing constraints affect ERGAMISOL availability?

Not determinable without NDC-specific supply history.

What is ERGAMISOL’s financial trajectory: revenue, margins, and earnings impact?

Answer: Not determinable. Financial trajectory requires verified sales metrics (e.g., company segment reporting, wholesaler/dispensing data, or public disclosures tied to the exact product).

What are ERGAMISOL’s annual net sales since launch?

Not determinable without launch year and product-level sales disclosures.

How does ERGAMISOL contribute to company revenue and operating income?

Not determinable without the manufacturing company and segment reporting.

What has happened to ERGAMISOL pricing: list price, rebates, and net-to-gross?

Not determinable without net price and rebate data.

How does ERGAMISOL compare with alternative therapies in the same class?

Answer: Not determinable. Comparative dynamics depend on clinical differentiation and payer preference mechanisms.

Is ERGAMISOL preferred due to efficacy, safety, or administration?

Not determinable without indication and comparative endpoints.

How does ERGAMISOL’s formulary position compare with peer brands?

Not determinable without formulary datasets.

Does ERGAMISOL face step-therapy or prior authorization constraints?

Not determinable without coverage policies.

What regulatory milestones affect ERGAMISOL adoption and revenue growth?

Answer: Not determinable without the FDA approval history and supplement timeline.

What FDA approvals and label expansions does ERGAMISOL have?

Not determinable without approval dates and labeling scope.

What is ERGAMISOL’s pathway status (e.g., NDA, BLA, 505(b)(2))?

Not determinable without regulatory dossier mapping.

Are there ongoing safety or risk-management updates tied to ERGAMISOL?

Not determinable without postmarketing requirements history.

What litigation or enforcement actions affect ERGAMISOL market access?

Answer: Not determinable. Litigation impacts require specific Orange Book patents, ANDA/BLA challenges, and court dockets.

What patent litigation affects ERGAMISOL?

Not determinable without patent lists and case dockets.

Has ERGAMISOL faced FDA enforcement related to manufacturing or labeling?

Not determinable without regulatory history.

Key Takeaways

Not computable from available inputs. ERGAMISOL market dynamics and financial trajectory require a product-to-identifier mapping (active ingredient, dosage form/strength, manufacturer, approved indication(s), and FDA/NDC) and then a second pass through Orange Book, FDA regulatory records, and sales/disclosure sources.

FAQs

1. Is ERGAMISOL the same as another brand under a different spelling or active ingredient?
2. What is the FDA approval date for ERGAMISOL and does it drive exclusivity?
3. Which patents are listed for ERGAMISOL in the Orange Book and when do they expire?
4. Are there Paragraph IV ANDA challenges for ERGAMISOL and what were the settlement outcomes?
5. What net price and rebate pressure has ERGAMISOL faced versus its therapeutic peers?

References (APA)

No cited sources available because no ERGAMISOL-specific identifiers or records were provided.