NORMOZIDE Drug Patent Profile

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

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
Raw Ingredient (Bulk) Api Vendors:	72
DailyMed Link:	NORMOZIDE at DailyMed

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

Expired US Patents for NORMOZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987

International Patents for NORMOZIDE

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

Country	Patent Number	Title	Estimated Expiration
Austria	280996
Austria	300763
Belgium	704037
Belgium	752892

Supplementary Protection Certificates for NORMOZIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
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

Last updated: June 25, 2026

NORMOZIDE market dynamics and financial trajectory (pricing, volume, exclusivity, and generic risk)

NORMOZIDE has no verifiable, public FDA/Orange Book footprint, and there is no authoritative public record of U.S. approvals, labeling, sales performance, or filed Abbreviated New Drug Applications that would support a defensible market-sizing or exclusivity timeline. Without sourceable identifiers tied to the drug’s active ingredient(s), dosage form(s), manufacturer, and regulatory status, any financial trajectory would be speculative.

What is NORMOZIDE (active ingredient, strength, dosage form) and who markets it?

No complete, sourceable drug identity for “NORMOZIDE” is available from authoritative public records in the provided context. A market dynamics or financial trajectory analysis requires at minimum: the U.S. NDA/ANDA number, active ingredient(s) (INN/USP), dosage form/strength, route of administration, sponsor/labeler, and FDA approval date.

What active ingredient does NORMOZIDE contain?

Not determinable from available information.

What formulation and route does NORMOZIDE use?

Not determinable from available information.

Which company holds the U.S. approval and label?

Not determinable from available information.

What patents protect NORMOZIDE and what is the Orange Book status?

No Orange Book patent listing or FDA “Orange Book” mapping to “NORMOZIDE” is verifiable from the provided context. Without a confirmed drug identity (NDA/labeler), patent coverage and expiration dates cannot be established.

How many Orange Book-listed patents cover NORMOZIDE?

Not determinable from available information.

When do NORMOZIDE exclusivities end (Hatch-Waxman, 5-year, 3-year, pediatric)?

Not determinable from available information.

Is NORMOZIDE challenged through Paragraph IV?

Not determinable from available information.

When does NORMOZIDE lose exclusivity and what is the generic entry risk?

No confirmed FDA exclusivity dates or ANDA filing history can be matched to “NORMOZIDE” from the provided context. Generic entry risk depends on: patent expiry calendar, exclusivity end dates, and any authorized generic or settlement terms.

What is the earliest plausible generic launch date?

Not determinable from available information.

What is the biosimilar or interchangeable risk (if biologic)?

Not determinable from available information.

What FDA approval pathway does NORMOZIDE use and what are the labeling constraints?

NORMOZIDE’s regulatory status and approval pathway are not verifiable from the provided context.

Is NORMOZIDE an NDA, ANDA, or 505(b)(2) product?

Not determinable from available information.

What are the approved indications and restrictions?

Not determinable from available information.

What post-marketing requirements apply to NORMOZIDE?

Not determinable from available information.

How does NORMOZIDE price, reimbursement, and channel mix affect revenue?

No pricing, WAC/AMP/wholesale acquisition or payer positioning data can be tied to “NORMOZIDE” from the provided context. Revenue trajectory analysis requires at least one of: CMS ASP/AMP series, IQVIA/GoodRx-type price index, wholesaler buy-in trends, or payer coverage evidence.

What are the typical drivers of unit growth or decline for NORMOZIDE?

Not determinable from available information.

What is the likely impact of manufacturer contracting, PBM formulary placement, and step edits?

Not determinable from available information.

Is NORMOZIDE facing substitution pressure from therapeutically equivalent drugs?

Not determinable from available information.

How does NORMOZIDE compare with competitors in its therapeutic class?

No therapeutic class or competitive set can be established from the provided context. A comparison requires: active ingredient, mechanism, approved indications, and dosage/risk profile.

Which drugs compete with NORMOZIDE by indication and mechanism?

Not determinable from available information.

What is the expected competitive erosion pattern if exclusivity expires?

Not determinable from available information.

How does NORMOZIDE’s dosing frequency and administration method influence adoption?

Not determinable from available information.

What patent litigation affects NORMOZIDE and how do settlements shape market share?

No litigations, dockets, or settlement terms for “NORMOZIDE” can be verified from the provided context.

Have there been ANDA Paragraph IV lawsuits?

Not determinable from available information.

Were there Hatch-Waxman settlements with a launch date carve-out?

Not determinable from available information.

Do any injunctions or consent judgments affect entry timing?

Not determinable from available information.

What manufacturing/IP barriers exist for generic or follow-on products?

No confirmed drug identity means no verifiable CMC package, manufacturing site constraints, or process/particle-size/formulation IP set can be mapped.

Are there process patents or device/packaging patents covering NORMOZIDE?

Not determinable from available information.

Are there REMS constraints or cold-chain requirements that raise barriers?

Not determinable from available information.

Does NORMOZIDE rely on proprietary intermediates or sterile manufacturing?

Not determinable from available information.

NORMOZIDE financial trajectory: historical revenue, growth drivers, and downside scenarios

No sourceable historical revenue, volume (TRx), or financial disclosures can be connected to “NORMOZIDE” from the provided context. As a result, the financial trajectory cannot be constructed without fabricating facts.

What was NORMOZIDE’s revenue and unit trend by year?

Not determinable from available information.

What is the base-case forecast for NORMOZIDE through the next exclusivity window?

Not determinable from available information.

What are the downside scenarios tied to generic entry and price erosion?

Not determinable from available information.

Key Takeaways

• NORMOZIDE cannot be tied to a verifiable U.S. regulatory identity, Orange Book record, exclusivity calendar, patent estate, litigation history, or sales dataset in the provided context.
• Market dynamics and financial trajectory analysis would require an NDA/ANDA mapping to establish the regulatory and patent timeline that drives generic risk and pricing pressure.

FAQs

1. How do I find NORMOZIDE’s NDA/ANDA number to check exclusivity and patents?
2. What Orange Book fields must be reviewed to determine earliest generic launch for a brand drug?
3. How do Paragraph IV filing dates correlate with expected final FDA approval timelines?
4. What pricing metrics (AMP, ASP, WAC) best track revenue trajectory for specialty versus generic-competitive products?
5. How do settlements under 35 U.S.C. § 271(e)(2) typically delay or permit generic entry?

References

No citable sources are available from the provided context.