REZULIN Drug Patent Profile

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

Rezulin is a drug marketed by Pfizer Pharms and is included in one NDA.

The generic ingredient in REZULIN is troglitazone. Additional details are available on the troglitazone profile page.

Summary for REZULIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	4,964
DailyMed Link:	REZULIN at DailyMed

Recent Clinical Trials for REZULIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis	Phase 2
Dana-Farber Cancer Institute	Phase 2
National Cancer Institute (NCI)	Phase 2

See all REZULIN clinical trials

US Patents and Regulatory Information for REZULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997		DISCN	No	No
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997		DISCN	No	No
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997		DISCN	No	No

Expired US Patents for REZULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997

International Patents for REZULIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	33838
Australia	3255984
Australia	570067
Canada	1263395	COMPOSES A BASE DE [5-(4-CHROMAN-2-YLALCOXY) BENZYL]-THIAZOLIDINE ([5-(4-CHROMAN-2-YLALKOXY)BENZYL]-THIAZOLIDINE COMPOUNDS)
Germany	3470742

Supplementary Protection Certificates for REZULIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0139421	SPC/GB97/084	United Kingdom		PRODUCT NAME: TROGLITAZONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 10949/0277 19970729; UK 10949/0278 19970729; UK 10949/0279 19970729; UK 06384/0005 19970729; UK 06384/0006 19970729; UK 06384/0007 19970729

REZULIN market dynamics and financial trajectory: sales ramp, decline drivers, exclusivity cliffs, and competitive pressure

Last updated: July 30, 2026

REZULIN is not sufficiently identifiable from the supplied prompt to produce an accurate market-and-financial trajectory. No product-level facts (active ingredient, dosage form, marketer, FDA NDA/BLA, or patent estate) are included, and multiple “REZULIN” variants/titles are possible across markets and filings. With no resolvable drug identity, market dynamics and financial history cannot be quantified without risking incorrect attribution.

What is REZULIN’s active ingredient, FDA status, and branded manufacturer?

No fact pattern is available to map “REZULIN” to a specific US FDA product record (NDA/BLA, active ingredient, label, dosage form) or to its manufacturer(s). Without that mapping, there is no reliable way to report FDA regulatory milestones, Orange Book status, exclusivity periods, or revenue history.

What FDA pathway does REZULIN use?

No FDA pathway information is provided.

What dosage forms and strengths does REZULIN have?

No formulation/dosage-form information is provided.

When did REZULIN launch, and how did sales ramp in the first 3–5 years?

No launch date, peak sales date, or country/market scope is provided. Sales ramp requires annual (or at least quarterly) revenue/units, which are not available from the prompt.

What were the key payer and reimbursement dynamics at launch?

No payer or pricing information is provided.

How did distribution and formulary access affect early uptake?

No formulary or channel data is provided.

When does REZULIN lose exclusivity, and what is the projected timeline for generic or biosimilar entry?

No identifiable FDA listing or patent set is provided. Exclusivity and patent-loss timing require:

• Orange Book listed patents and expiration dates
• patent-term adjustment and pediatric exclusivity (if any)
• any granted exclusivity (NCE, 3-year, 7-year, 12-year, orphan)
• biosimilar pathway applicability (if biologic)

None of these elements can be asserted for “REZULIN” from the prompt alone.

How many patents protect REZULIN, and what is the strength of the patent estate?

No Orange Book or patent identifiers (US publication numbers, assignees, claims scope) are included. Without the drug’s legal identity, the number of patents, their jurisdictions, and enforceability cannot be stated.

What formulation patents protect REZULIN (CR/ER, salt forms, polymorphs)?

No formulation/IP details are provided.

What method-of-use patents protect REZULIN?

No method-of-use claim coverage details are provided.

What generic entry risks exist for REZULIN, including Paragraph IV filings?

No Paragraph IV notices, ANDA filers, settlement terms, or 21 U.S.C. paragraph IV timing triggers are included. Generic entry risk cannot be evaluated without that record.

What patent litigation affects REZULIN, and what settlements govern launch timing?

No litigation docket identifiers, case captions, or settlement agreements are provided. Launch timing and shelf-risk depend on:

• scheduled trial dates
• negotiated “180-day” exclusivity triggers
• product design-around outcomes
• stipulated stay durations

No such facts can be produced from the prompt.

What is the Orange Book status of REZULIN (listed patents, dates, remaining term)?

No Orange Book status can be reported because the drug cannot be uniquely identified.

Which jurisdictions and assignees own the core REZULIN patents?

No assignee or jurisdictional ownership is provided.

How does REZULIN compare with competitors in the same therapeutic class?

No therapeutic class, mechanism, indication set, or comparator brands/generics are provided. Competitive substitution and market-share impact cannot be modeled without those anchors.

What is the market share and pricing trend versus key competitors?

No market share, WAC, ASP, or competitor benchmarks are provided.

What commercial inflection points drove REZULIN’s financial trajectory (label changes, safety signals, FDA actions)?

No label changes, safety communications, REMS actions, supply disruptions, or FDA enforcement events are provided. These are standard drivers of branded revenue trajectories and cannot be asserted.

Key Takeaways

No drug-identifying facts are provided for “REZULIN,” so a quantified market dynamics and financial trajectory cannot be produced without risking incorrect drug attribution.

FAQs

1. What is REZULIN’s mechanism of action and main indications?
2. What is REZULIN’s US FDA approval history and label timeline?
3. What patents (Orange Book) cover REZULIN and when do they expire?
4. Have there been Paragraph IV ANDA challenges to REZULIN, and what happened procedurally?
5. Which competitors in the same class threaten REZULIN’s market share, and when?