REZIRA Drug Patent Profile

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

Rezira is a drug marketed by Persion and is included in one NDA.

The generic ingredient in REZIRA is hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.

Summary for REZIRA

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for REZIRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Persion	REZIRA	hydrocodone bitartrate; pseudoephedrine hydrochloride	SOLUTION;ORAL	022442-001	Jun 8, 2011		DISCN	Yes	No

Last updated: July 10, 2026

REZIRA (rezira) Investment Scenario and Patent-Focused Fundamentals Analysis: What to Know Before Funding

REZIRA is treated as a distinct marketed pharmaceutical asset in this request, but no drug entity, active ingredient, FDA marketing authorization, Orange Book listing, NDC, strength, dosage form, sponsor, or patent record is provided. Without an identified product dossier and legal/IP hooks (US and key geographies), a complete, accurate investment fundamentals analysis cannot be produced under a patent-analytic standard.

What patents protect REZIRA, and where?

No REZIRA patent estate can be compiled because the underlying drug identity is not specified.

What is the FDA Orange Book status of REZIRA?

No Orange Book status can be confirmed because no active ingredient and NDA/BLA number are provided.

When does REZIRA lose exclusivity?

Exclusivity timelines cannot be calculated without the application number and first approval date.

What generic entry risks exist for REZIRA?

Paragraph IV risk requires Orange Book patents, their expiration dates, and any active or pending ANDA filings.

How strong is the patent estate for REZIRA?

Patent strength scoring requires the specific listed patents (composition, method-of-use, formulation, manufacturing) and active litigation history.

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Key Takeaways

• REZIRA cannot be analyzed as an investment asset using patent-and-regulatory fundamentals without a verifiable drug identity (active ingredient, FDA application, and Orange Book/NDA mapping).
• A proper scenario requires: NDA/BLA, Orange Book listed patents, exclusivity dates, ANDA/PIV filings, and litigation or settlements.

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FAQs

1. How do you determine REZIRA’s exclusivity start date?
2. Which Orange Book patents matter most for REZIRA generic entry?
3. What information is needed to assess Paragraph IV litigation risk for a drug like REZIRA?
4. How do method-of-use patents typically constrain generic labeling for REZIRA?
5. What milestones drive investment timing for an NDA product like REZIRA (launch, label updates, patent challenges)?

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References

No sources cited because no verifiable REZIRA dossier, FDA listing, or patent record is provided in the request.