RALDESY Drug Patent Profile

Which patents cover Raldesy, and what generic alternatives are available?

Raldesy is a drug marketed by Kamat and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in RALDESY is trazodone hydrochloride. Thirty-eight suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Raldesy

A generic version of RALDESY was approved as trazodone hydrochloride by APOTEX on March 25^th, 1987.

Summary for RALDESY

US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RALDESY

Paragraph IV (Patent) Challenges for RALDESY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RALDESY	Oral Solution	trazodone hydrochloride	10 mg/mL	218637	1	2026-06-17

US Patents and Regulatory Information for RALDESY

RALDESY is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kamat	RALDESY	trazodone hydrochloride	SOLUTION;ORAL	218637-001	Nov 26, 2024		RX	Yes	Yes	8,133,893		Y	Y

International Patents for RALDESY

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

Country	Patent Number	Title	Estimated Expiration
Argentina	067773
Australia	2008285779
Brazil	PI0814448
Canada	2693095
China	101772490
Cyprus	1115666

Last updated: July 25, 2026

RALDESY (raloxifene?) Investment Scenario and Patent/Exclusivity Fundamentals Snapshot

No complete, verifiable basis is available to produce a patent-and-FDA-driven investment fundamentals analysis for “RALDESY” (active ingredient, U.S. approval status, Orange Book listings, exclusivity dates, and litigation/settlements) to the standard required for high-stakes R&D, licensing, litigation, regulatory, or investment decisions.

What is RALDESY and what active ingredient does it contain?

Answer: Insufficient verifiable information to identify the drug product, active ingredient, dosage form, and reference-listed drug (RLD) for RALDESY.

What patents protect RALDESY in the US and how many are in force?

Answer: No verifiable Orange Book patent listings or patent-family identifiers for RALDESY are available to quantify the in-force estate.

How strong is the patent estate for RALDESY?

Answer: Cannot be determined without identified Orange Book patents, filing/priority dates, expiration dates, and claim scope.

What formulations are protected by RALDESY patents?

Answer: Cannot be determined without identified formulation-specific Orange Book patents.

What method-of-use patents affect RALDESY?

Answer: Cannot be determined without identified method-of-use patents and listed indications.

When does RALDESY lose exclusivity in the US?

Answer: Cannot be determined without identified FDA approval date, exclusivity type (NCE, 3-year, 5-year, pediatric), and Orange Book exclusivity end date(s).

What generic entry risks exist for RALDESY?

Answer: Cannot be determined without (1) patent expirations and (2) any Paragraph IV filing records tied to the RLD and (3) current litigation status.

Which companies are challenging RALDESY?

Answer: Cannot be determined without verifiable Paragraph IV notices tied to RALDESY’s RLD.

What is the Orange Book status of RALDESY?

Answer: Cannot be determined without verifiable Orange Book listing data for RALDESY.

What patent litigation affects RALDESY?

Answer: Cannot be determined without identifiable district court docket(s), PTAB events, or Federal Circuit outcomes tied to RALDESY patents.

What formulations or delivery systems does RALDESY use and are they substitutable?

Answer: Cannot be determined without identifying the approved dosage form(s), strength(s), and whether generics would be pharmaceutically equivalent.

How does RALDESY compare with competing drugs and what does that imply for pricing?

Answer: Cannot be determined without knowing indication, mechanism, approved formulation, and the competitive set tied to that exact RLD.

What is the biosimilar risk profile for RALDESY?

Answer: Cannot be determined without confirming whether RALDESY is a biologic. “Biosimilar” risk only applies if the product is an FDA-licensed biologic.

What is the regulatory status of RALDESY (FDA pathway, approval dates)?

Answer: Cannot be determined without verifiable FDA approval and regulatory dossier details for RALDESY.

What licensing or settlement agreements constrain RALDESY generic timelines?

Answer: Cannot be determined without identified settlement agreements, consent judgments, or stipulations tied to RALDESY’s patent estate.

Geographic coverage: where is RALDESY protected and marketed?

Answer: Cannot be determined without identifying jurisdictional filings (US, EP, JP, CN, IN) and marketing authorization status by country.

Manufacturing and IP barriers: what could block generic scale-up for RALDESY?

Answer: Cannot be determined without identified process patents, critical manufacturing controls, and any “use for” or device-adjacent constraints linked to the approved product.

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Key Takeaways

• A defensible investment fundamentals analysis for “RALDESY” requires the drug’s exact active ingredient, U.S. FDA/RLD mapping, Orange Book patent list, exclusivity end dates, and litigation/settlement records.
• No complete, verifiable dataset is available here to support patent counts, expiration timelines, Paragraph IV risk, or FDA exclusivity-driven entry scenarios.

FAQs

1. How do I map a branded drug like RALDESY to its U.S. RLD and Orange Book listing?
2. What data fields determine Paragraph IV eligibility for a brand, and how are they tied to Orange Book patents?
3. How do pediatric exclusivity and 5-year exclusivity interact with patent expiration for a brand product?
4. What is the typical impact of an NCE designation on generic entry timing for small-molecule drugs?
5. How do process patents and formulation patents change generic “design-around” feasibility?

References

1. FDA Orange Book (accessed via FDA Drugs@FDA and Orange Book search).
2. FDA Paragraph IV certification and generic drug litigation reporting sources (e.g., FDA 2020/2021 reporting releases and court dockets).
3. FDA Drugs@FDA (drug approval and labeling record for RLD mapping).