NORMOZIDE Drug Patent Profile

When do Normozide patents expire, and what generic alternatives are available?

Normozide is a drug marketed by Schering and is included in one NDA.

The generic ingredient in NORMOZIDE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.

Summary for NORMOZIDE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for NORMOZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987		DISCN	No	No
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987		DISCN	No	No
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987		DISCN	No	No
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987		DISCN	No	No

International Patents for NORMOZIDE

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

Country	Patent Number	Title	Estimated Expiration
Sweden	372935
Canada	983524	PHENYLAMINOETHANOL DERIVATIVES
Netherlands	7010126
Netherlands	160805
Yugoslavia	86768
Malaysia	7400003	PHENYLAMINOETHANOL DERIVATIVES
Denmark	278575

Supplementary Protection Certificates for NORMOZIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009

Last updated: April 25, 2026

NORMOZIDE Investment Scenario and Fundamentals Analysis

What is NORMOZIDE and what is its market basis?

Insufficient product-identification data is provided to establish what “NORMOZIDE” refers to in a regulatory or commercial context (for example: active ingredient(s), dosage form, indication, country, brand vs. INN naming, or marketing authorization holder). Without an unambiguous product definition, the investment scenario cannot be tied to enforceable IP (patents, data exclusivity, market exclusivity), filed clinical evidence, or real-world market uptake.

What are the patent and exclusivity fundamentals for NORMOZIDE?

A fundamentals analysis requires at least one of the following to construct a credible patent landscape: (1) active ingredient and salt form; (2) branded product’s marketing authorization number; (3) applicant/assignee and representative patent family; or (4) country-specific authorization and exclusivity record. No such anchors are supplied, so claims about patent term, expiry cliffs, PTE/PB extensions, exclusivity periods, or paragraph IV risk cannot be produced in a manner that is accurate or decision-grade.

What is the clinical and regulatory status that drives valuation?

Valuation hinges on approved indications, label scope, development-stage evidence, and regulatory timeline (NDA/BLA status, FDA/EMA decisions, major review milestones, and post-approval commitments). No indication, MOA, or regulatory status is provided for NORMOZIDE, so clinical and regulatory fundamentals cannot be mapped to probability-adjusted cash flows.

What does a cash-flow model require and what is missing?

A drug investment model typically decomposes value into:

• Peak sales (indication size, share, pricing, payer coverage)
• Time to peak (ramp and switching dynamics)
• Gross-to-net (rebates, discounts, distribution terms)
• Cost curve (COGS, operating margin, SG&A burden)
• Exclusivity and generic entry timing (patent barriers, regulatory exclusivity)
• Risk multipliers (label erosion, competitor pipeline, safety signals, manufacturing constraints)

No product inputs are supplied for NORMOZIDE, so any attempt to forecast revenues, exclusivity windows, or competitive dynamics would not be anchored to verifiable fundamentals.

Is NORMOZIDE differentiated versus the competitive set?

Differentiation analysis requires:

• Target biology and mechanism of action
• Comparative efficacy/safety benchmarks
• Dosing, formulation, adherence advantages
• Label breadth and contraindication/safety profile
• Line-of-therapy positioning

None of these attributes are provided, so competitive differentiation cannot be evaluated.

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Key Takeaways

• NORMOZIDE cannot be analyzed for investment fundamentals without an unambiguous product definition (active ingredient, dosage form, indication, and regulatory/brand identifiers).
• Patent and exclusivity, the core of drug valuation, cannot be mapped to a decision-grade landscape without product-identifying anchors.
• Clinical and regulatory drivers cannot be assessed because no approval status, label, or development-stage details are supplied.

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FAQs

1. What does NORMOZIDE refer to?
   The prompt does not include the active ingredient, INN, dosage form, indication, or jurisdictional identifiers needed to determine what product “NORMOZIDE” is.

2. Can you estimate exclusivity expiry for NORMOZIDE?
   Not from the provided information, because exclusivity depends on authorization details tied to specific jurisdictions and labeled products.

3. What information is needed to build a valuation model?
   A product definition plus market and regulatory inputs (indication, label scope, pricing context, patent/exclusivity timelines, and competitor landscape).

4. How do patents and paragraph IV risks affect NORMOZIDE value?
   Those effects require a patent family map (assignees, claim scope, jurisdictions, and enforcement posture), which cannot be constructed from the current inputs.

5. What are the biggest drivers of adoption for a branded drug?
   Indication size, payer coverage, clinical differentiation, dosing convenience, and safety/tolerability, none of which are provided for NORMOZIDE.