Last Updated: August 8, 2026

NYSTAFORM Drug Patent Profile

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When do Nystaform patents expire, and when can generic versions of Nystaform launch?

Nystaform is a drug marketed by Bayer Pharms and is included in one NDA.

The generic ingredient in NYSTAFORM is clioquinol; nystatin. There is one drug master file entry for this compound. Additional details are available on the clioquinol; nystatin profile page.

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Summary for NYSTAFORM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	16
DailyMed Link:	NYSTAFORM at DailyMed

Drug patent expirations by year for NYSTAFORM

US Patents and Regulatory Information for NYSTAFORM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	NYSTAFORM	clioquinol; nystatin	OINTMENT;TOPICAL	050235-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

NYSTAFORM market dynamics and financial trajectory: launch timing, payer and competitor pressure, and IP-driven revenue outlook

Last updated: July 25, 2026

No complete, accurate commercial/financial dataset for “NYSTAFORM” is available here, so a defensible market-dynamics and financial-trajectory assessment cannot be produced without risking factual errors (for example, product identity, NDA/ANDA association, launch status, or revenue figures).

What is NYSTAFORM and what product does the market treat it as?

Answer: Not determinable from the provided prompt content.

Is NYSTAFORM an NDA, ANDA, or branded repackaging?

Answer: Not determinable from the provided prompt content.

What active ingredient and therapeutic class is NYSTAFORM?

Answer: Not determinable from the provided prompt content.

How does NYSTAFORM’s launch timing shape adoption curves and revenue?

Answer: Not determinable from the provided prompt content.

When was NYSTAFORM approved and first marketed?

Answer: Not determinable from the provided prompt content.

What FDA pathway applied to NYSTAFORM (NME, 505(b)(2), generic)?

Answer: Not determinable from the provided prompt content.

What patents, exclusivities, and FDA listings govern NYSTAFORM cash flows?

Answer: Not determinable from the provided prompt content.

What is the Orange Book status of NYSTAFORM?

Answer: Not determinable from the provided prompt content.

When does exclusivity end and when can generics challenge?

Answer: Not determinable from the provided prompt content.

Are there paragraph IV filings or biosimilar-style risks?

Answer: Not determinable from the provided prompt content.

Which competitors pressure NYSTAFORM pricing and share?

Answer: Not determinable from the provided prompt content.

What is the reference standard drug mix and therapeutic substitution risk?

Answer: Not determinable from the provided prompt content.

What biosimilar/generic entry threats exist by mechanism of action?

Answer: Not determinable from the provided prompt content.

What are NYSTAFORM’s payer dynamics: formularies, prior authorization, step edits, and discounts?

Answer: Not determinable from the provided prompt content.

How restrictive are coverage criteria for NYSTAFORM?

Answer: Not determinable from the provided prompt content.

Does NYSTAFORM compete on net price or rebate structure?

Answer: Not determinable from the provided prompt content.

What is NYSTAFORM’s financial trajectory: revenue trend, margin profile, and guidance impact?

Answer: Not determinable from the provided prompt content.

Reported revenue and growth rates

Answer: Not determinable from the provided prompt content.

Gross margin and operating expense drivers

Answer: Not determinable from the provided prompt content.

Segment contribution and investor guidance sensitivity

Answer: Not determinable from the provided prompt content.

How do distribution, manufacturing capacity, and supply constraints affect NYSTAFORM sales?

Answer: Not determinable from the provided prompt content.

Are there recorded shortages, recalls, or capacity limits?

Answer: Not determinable from the provided prompt content.

What litigation and settlements could change NYSTAFORM’s revenue runway?

Answer: Not determinable from the provided prompt content.

Is NYSTAFORM involved in Hatch-Waxman or state-law disputes?

Answer: Not determinable from the provided prompt content.

Do settlements lock in market entry dates or limit inducement?

Answer: Not determinable from the provided prompt content.

Key Takeaways

Answer: NYSTAFORM market dynamics and financial trajectory cannot be assessed accurately from the provided prompt content.

FAQs

What is NYSTAFORM’s FDA approval date and current marketing status?
Not determinable from the provided prompt content.
What exclusivity protections does NYSTAFORM have in the US?
Not determinable from the provided prompt content.
What generic entry risks exist for NYSTAFORM?
Not determinable from the provided prompt content.
Which drugs compete with NYSTAFORM for the same indication and patient population?
Not determinable from the provided prompt content.
What reported revenue has NYSTAFORM generated and how fast has it grown?
Not determinable from the provided prompt content.

References

No sources were provided or retrievable within the prompt content to cite.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.