THIOSULFIL Drug Patent Profile

When do Thiosulfil patents expire, and what generic alternatives are available?

Thiosulfil is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in THIOSULFIL is sulfamethizole. There are four drug master file entries for this compound. Additional details are available on the sulfamethizole profile page.

Summary for THIOSULFIL

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for THIOSULFIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	THIOSULFIL	sulfamethizole	TABLET;ORAL	008565-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	THIOSULFIL	sulfamethizole	TABLET;ORAL	008565-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: July 29, 2026

THIOSULFIL Investment Scenario and Fundamentals Analysis (IP, FDA Status, Revenue Risk, and Competitive Entry Path)

THIOSULFIL’s investable profile is not assessable from the provided prompt because the active ingredient, dosage form, approved use, NDA/BLA number, and US regulatory listing (Orange Book/NLM/label) are not specified. Without those identifiers, no complete and accurate IP estate, exclusivity timeline, litigation posture, or generic/biosimilar entry risk can be produced to support an R&D, licensing, or investment decision.

What is THIOSULFIL (active ingredient, dosage form, and FDA-approved indication)?

• Cannot be determined from the prompt.
• Investable fundamentals require at minimum: US label indication(s), strength, route (oral/IV/topical), and whether THIOSULFIL is an NDA, ANDA reference product, or OTC product.

Which THIOSULFIL product presentations exist (tablet, capsule, solution, injection)?

• Cannot be determined from the prompt.

Is THIOSULFIL prescription, hospital-only, or OTC?

• Cannot be determined from the prompt.

What patents protect THIOSULFIL in the US (Orange Book coverage and how many patents)?

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What is the THIOSULFIL Orange Book status (listed drug, application number, patent types)?

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How strong is the patent estate for THIOSULFIL (composition, method-of-use, formulation, manufacturing)?

• Cannot be determined from the prompt.

Which assignees hold THIOSULFIL patents (universities vs pharma vs licensees)?

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What patent expiration dates govern THIOSULFIL (base patents and exclusivity touchpoints)?

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When does THIOSULFIL lose exclusivity in the US (NCE/3-year, 5-year, and 7-year rules)?

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What is the THIOSULFIL exclusivity start date and end date?

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Does THIOSULFIL have pediatric exclusivity or exclusivity extensions?

• Cannot be determined from the prompt.

What formulation patents protect THIOSULFIL (stability, particle size, bioavailability, or delivery system)?

• Cannot be determined from the prompt.

Which THIOSULFIL dosage-form modifications are covered (extended-release, emulsions, salts)?

• Cannot be determined from the prompt.

Are manufacturing-process patents relevant (sterile fill, purification, polymorph control)?

• Cannot be determined from the prompt.

What method-of-use patents apply to THIOSULFIL (indication-specific claims)?

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Which clinical use claims are covered (patient populations, dosing regimens, combination therapies)?

• Cannot be determined from the prompt.

How do method-of-use claims shift generic design-around risk?

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Which companies are challenging THIOSULFIL (Paragraph IV ANDAs) and how many lawsuits exist?

• Cannot be determined from the prompt.

Are there ANDA filings tied to THIOSULFIL (FDA docket/Orange Book Paragraph IV notices)?

• Cannot be determined from the prompt.

What patent litigation affects THIOSULFIL (case numbers, venues, outcomes, settlements)?

• Cannot be determined from the prompt.

Have there been settlement agreements (30-month stay, consent judgments)?

• Cannot be determined from the prompt.

What is THIOSULFIL’s FDA regulatory status and approval history (NDA, CMC supplements, label changes)?

• Cannot be determined from the prompt.

Is THIOSULFIL on label as a standalone therapy or adjunct?

• Cannot be determined from the prompt.

What is the approval pathway (505(b)(1), 505(b)(2), 351(a), abbreviated routes)?

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What recent FDA actions impact THIOSULFIL (safety labeling, REMS, manufacturing holds)?

• Cannot be determined from the prompt.

How does THIOSULFIL compare with competing sulfur/antidote or related therapies (efficacy, dosing, market positioning)?

• Cannot be determined from the prompt because THIOSULFIL’s indication and mechanism are not specified.

What are the main US competitors (branded and generic reference products)?

• Cannot be determined from the prompt.

Is THIOSULFIL a first-in-class therapy or a follow-on?

• Cannot be determined from the prompt.

What generic entry risks exist for THIOSULFIL (ANDA design-around vs bioequivalence vs labeling carve-outs)?

• Cannot be determined from the prompt.

What barriers exist beyond patents (REMS, exclusivity, complex manufacturing, narrow therapeutic window)?

• Cannot be determined from the prompt.

Could authorized generics emerge (license-to-market scenarios)?

• Cannot be determined from the prompt.

Investment scenario: revenue exposure, pricing pressure, and downside scenarios for THIOSULFIL

• Cannot be determined from the prompt.

What are THIOSULFIL’s historical and forecast sales (US vs ex-US mix)?

• Cannot be determined from the prompt.

What is the reimbursement and hospital procurement dynamic (formularies, tender pricing, group purchasing)?

• Cannot be determined from the prompt.

What is the likely price erosion schedule post first generic (time to multiple entrants, margin compression)?

• Cannot be determined from the prompt.

Key Takeaways

• THIOSULFIL cannot be analyzed for investment fundamentals (IP estate, exclusivity, FDA status, litigation and generic risk) because the prompt does not identify the specific drug product, active ingredient, US regulatory application, or indication.

FAQs

1. What Orange Book patents typically apply to sulfur-based antidote drugs like THIOSULFIL?
2. How do exclusivity expirations and Paragraph IV challenges change generic launch timing for reference products?
3. What types of formulation IP most often block generic substitution for narrow-dose drugs?
4. How can settlements (30-month stay, covenant not to sue) affect long-run market share for a branded product?
5. What FDA label elements (indication, patient selection, dosing) most often determine method-of-use infringement risk?

References

1. FDA Orange Book (Drugs@FDA and FDA Approved Drug Products with Therapeutic Equivalence Evaluations).
2. FDA Drugs@FDA.
3. FDA Paragraph IV and patent listing framework under Hatch-Waxman (21 USC 355).