ZIPAN-50 Drug Patent Profile

When do Zipan-50 patents expire, and what generic alternatives are available?

Zipan-50 is a drug marketed by Altana and is included in one NDA.

The generic ingredient in ZIPAN-50 is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zipan-50

A generic version of ZIPAN-50 was approved as promethazine hydrochloride by ZYDUS PHARMS USA on November 18^th, 2005.

Summary for ZIPAN-50

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ZIPAN-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Altana	ZIPAN-50	promethazine hydrochloride	INJECTABLE;INJECTION	083997-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: July 20, 2026

ZIPAN-50 investment scenario and fundamentals analysis: FDA status, exclusivity, patent risks, and generic/biosimilar outlook

ZIPAN-50 is not identifiable from public pharmaceutical reference data by drug name, label strength, active ingredient, or manufacturer in a way that supports an investment-grade fundamentals and IP risk analysis. Without a uniquely mapped active ingredient (and the corresponding NDA/ANDA/BLA and Orange Book entry), any statement about exclusivity, patent estate, Paragraph IV risk, FDA pathway, litigation, pricing, or competitive entry would be unverifiable.

No complete and accurate response can be produced from the information provided.

Key Takeaways

• ZIPAN-50 cannot be mapped to an identifiable FDA product record or patent/Orange Book family with the detail required for investment and IP diligence.
• No defensible analysis of exclusivity timelines, patent expiration dates, litigation status, or generic entry risk can be provided.
• No revenue exposure or commercial fundamentals can be quantified without identifying the active ingredient, applicant/holder, and product code.

FAQs

1. What is the active ingredient in ZIPAN-50, and which FDA application type does it reference (NDA/ANDA/BLA)?
2. What Orange Book listings exist for the ZIPAN-50 label strength, dosage form, and route of administration?
3. When does ZIPAN-50 lose regulatory exclusivity and patent protection (including PTE and method-of-use patents)?
4. Are there any Paragraph IV ANDA challenges filed against the Orange Book-listed patents for ZIPAN-50?
5. Who manufactures ZIPAN-50, and what is the competitive landscape by dosage form and strength?

References

No sources were cited because ZIPAN-50 could not be mapped to an identifiable FDA product and patent record from the provided prompt.