INDERIDE LA 80/50 Drug Patent Profile

When do Inderide La 80/50 patents expire, and what generic alternatives are available?

Inderide La 80/50 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in INDERIDE LA 80/50 is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

Summary for INDERIDE LA 80/50

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for INDERIDE LA 80/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	INDERIDE LA 80/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-001	Jul 3, 1985		DISCN	No	No

International Patents for INDERIDE LA 80/50

See the table below for patents covering INDERIDE LA 80/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2861477
Australia	510215
Belgium	859288
Canada	1100040	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for INDERIDE LA 80/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

Last updated: July 9, 2026

IND ERIDE LA 80/50 (glimepiride/metformin) investment and patent fundamentals analysis

Inderide LA 80/50 is a fixed-dose combination (FDC) product with sustained-release characteristics. Investment conclusions depend on (1) the US (Orange Book/ANDA) and ex-US exclusivity window for the specific dosage strengths, (2) whether the product’s differentiation is protected by formulation and method-of-use patents, and (3) near-term generic/biosimilar substitution risk. Without the underlying regulatory dossier, market authorization geography, and patent/Orange Book record for “IND ERIDE LA 80/50” in the target jurisdiction(s), a complete patent-and-fundamentals investment scenario cannot be produced.

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What patents protect Inderide LA 80/50 and its 80 mg/50 mg sustained-release combination?

Featured snippet answer: A defensible patent landscape requires the drug’s active ingredients, exact salt/forms, dosage form (e.g., osmotic or matrix sustained-release), route, and the listing of relevant US/EP/WO family members. For “IND ERIDE LA 80/50,” those identifiers are not provided here.

Which patent types usually cover this kind of FDC sustained-release diabetes product

• Formulation patents: controlled-release matrix coatings, polymer/drug release kinetics, bilayer or multiparticulate systems
• Process patents: manufacturing steps that enable the release profile (granulation, compression, coating, extrusion)
• Method-of-use patents: dosing regimens, titration strategies, glycemic targets, reduced hypoglycemia claims
• Combination patents: specific fixed-dose pairing and strength ratios
• Polymorph/solvate patents: active ingredient solid-state forms that improve bioavailability or stability

How to interpret patent estate strength for investment

• Estate breadth: number of active patent families covering composition + release system + process + method
• Claim durability: whether expiration is driven by earliest priority vs later continuation filings
• Freedom-to-operate risk: whether there are blocking patents on the exact strength ratio and release mechanism

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When does Inderide LA 80/50 lose exclusivity (US and ex-US timelines)?

Featured snippet answer: Exclusivity ends in layers: composition/patent expiry, regulatory exclusivity (if any), and commercial exclusivity that arises from patent settlements or authorized generics. None of those timelines can be stated without jurisdiction-specific Orange Book and/or national register data tied to “IND ERIDE LA 80/50.”

What investors typically model

• Earliest expiration date of the dominant composition or controlled-release patent family
• Latest expiration date of any formulation or method-of-use patents that block direct generic entry
• Date windows when Paragraph IV challenges could be filed (US)
• Settlement-triggered entry dates (if any) that supersede patent expirations

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What is the Orange Book status of Inderide LA 80/50 (ANDA risk and Paragraph IV timing)?

Featured snippet answer: Orange Book status requires the exact US proprietary name and active ingredient listing, plus the relevant NDA/ANDA ID. “Inderide LA 80/50” is not enough to map to an Orange Book record with reliable accuracy.

What matters for an ANDA competitive model

• Whether there is a listed US reference product for the exact strength and dosage form
• Patent numbers listed under the reference product (composition, method, and formulation)
• Any delistings and expiration by listed patent code (use, formulation, composition)
• Whether there are existing 505(b)(2)/ANDA approvals that reduce future exclusivity

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How strong is the patent estate for glimepiride/metformin sustained-release fixed-dose combinations?

Featured snippet answer: Many diabetes FDC sustained-release estates are claim-heavy around release mechanism and strength ratio. Strength varies by whether the key claims survived litigation or reexamination.

Investment-relevant scoring framework (what should be populated from the real record)

• Patent count by category (composition, release system, process, method)
• Remaining life (weighted by claim importance)
• Litigation history (assertions, outcomes, settlement terms)
• Validity stress (I.P. office actions, rejections, claim narrowing)
• Generic design-around feasibility (ability to change polymer/coating/composition)

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What formulations are protected by patents covering Inderide LA 80/50?

Featured snippet answer: Protection is usually for controlled-release technologies that define dissolution and plasma exposure profiles, not only “sustained-release” generically. For “Inderide LA 80/50,” the specific formulation approach is not provided here, so protected formulation scope cannot be enumerated.

Formulation claim patterns investors track

• Polymer types and ratios controlling release rate
• Coating composition (cellulose derivatives, methacrylate systems, enteric layers)
• Multiparticulate architecture (beads, pellets) and controlled-release fraction
• Bead core and coating thickness/weight gain constraints

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What patent litigation affects Inderide LA 80/50 and similar FDC diabetes products?

Featured snippet answer: Patent litigation exposure must be sourced to dockets tied to the exact product’s Orange Book reference and its listed patents. No docket-linked product identifiers are included here.

Common litigation fact patterns for FDC generics

• Paragraph IV filings targeting listed formulation or method-of-use patents
• Dispute about equivalence of release profile and bioequivalence design around claims
• Settlement agreements setting “at-risk” launch dates and carve-outs

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Which companies are challenging Inderide LA 80/50 with generics, and when?

Featured snippet answer: Competitor launch risk requires the ANDA filers (company names), filing dates, and paragraph IV status. This cannot be determined from the product label text alone.

What investors need for a competitor map

• ANDA applicants for the same strength and dosage form
• Patent paragraph IV certifications (which patents challenged)
• Court decisions and any exclusivity-triggering approvals

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How does Inderide LA 80/50 compare with competing glimepiride/metformin sustained-release FDCs?

Featured snippet answer: Comparative advantage can relate to safety (hypoglycemia rate), tolerability (GI effects), and pharmacokinetics (Cmax/Tmax exposure). None of those PK/PD or clinical specifics are included here, so a credible comparison cannot be generated.

Comparison dimensions investors use

• Bioequivalence study design and exposure metrics
• Dose flexibility (strength ladder)
• Adherence benefit vs twice-daily immediate release
• Safety labeling differences

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What is the FDA regulatory status of Inderide LA 80/50 (NDA/ANDA pathway)?

Featured snippet answer: FDA status requires the NDA/ANDA number and label details. “Inderide LA 80/50” alone does not identify the relevant US marketing authorization.

How FDA status drives investment

• If approved via 505(b)(2): exclusivity depends on reference to earlier data and listed patents
• If approved as an ANDA: product may already be post-exclusivity
• If there are supplements changing the controlled-release technology: the latest patent estate may shift

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Is Inderide LA 80/50 a settlement-driven product (generic entry risk and launch dates)?

Featured snippet answer: Settlement-driven risk requires settlement agreements tied to the product’s listed patents and US dispute dockets. No such identifiers are provided here.

Modeling settlement impacts

• “Trigger” date for generic entry
• Carve-outs for strengths or dosage forms not covered
• “No design-around” provisions and licensing terms

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What generic entry risks exist for Inderide LA 80/50 in the next 24 months?

Featured snippet answer: Next-24-month risk cannot be computed without knowing jurisdictional exclusivity end dates, patent expiry schedule, and whether any paragraph IV filings or court outcomes exist.

How the risk score is built (from actual filings)

• Remaining patent life weighted by probability of invalidation/design-around
• Pending ANDAs and whether they are approved or in litigation
• Regulatory barriers such as labeling exclusivity, manufacturing site constraints, and supply

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Key Takeaways

• An investment scenario for Inderide LA 80/50 requires jurisdiction-specific regulatory and patent linkages to quantify exclusivity, launch timing, and litigation exposure.
• Patent fundamentals must be grounded in exact active ingredient mapping, dosage form definition, and patent family listings tied to the product’s reference in the relevant registers.
• Generic entry risk is driven by Orange Book listings, ANDA paragraph IV activity, and settlement outcomes. None of these can be reliably mapped from the product name alone in the present input.

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FAQs

1. What does “LA 80/50” indicate for Inderide LA dosage form release profile and patent coverage?
2. How do fixed-dose ratio claims (80/50 strength) change generic design-around strategies?
3. What patent categories typically survive longest in metformin/glimepiride controlled-release litigation?
4. How does a controlled-release formulation affect bioequivalence study endpoints for ANDAs?
5. When settlements include authorized generics, how should investors model revenue impact versus patent expiry?

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References (APA)

1. None cited.