When will the CHLOROTHIAZIDE-RESERPINE patents expire, and when will generic CHLOROTHIAZIDE-RESERPINE be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	CHLOROTHIAZIDE-RESERPINE	chlorothiazide; reserpine	TABLET;ORAL	087744-001	May 6, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmobedient	CHLOROTHIAZIDE-RESERPINE	chlorothiazide; reserpine	TABLET;ORAL	087745-001	May 6, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 14, 2026

Chlorothiazide-reserpine is an older fixed-dose antihypertensive combination. The business case today is driven primarily by (1) the product’s residual market presence in specific geographies and payer channels, (2) the speed and certainty of generic availability, and (3) whether any country still grants meaningful exclusivity. For U.S. investors and generic-entry strategists, the core IP question is simple: fixed-dose combinations like this typically sit outside a long runway of brand exclusivity, so value creation depends on supply chain economics, channel access, and niche positioning rather than patent-protected moat.

What is chlorothiazide-reserpine used for, and what is its clinical and market relevance?

Featured snippet answer: Chlorothiazide-reserpine is used for hypertension management and historically competed as a fixed-dose regimen combining a thiazide diuretic (chlorothiazide) with a centrally acting antihypertensive agent (reserpine).

Therapeutic positioning

Class composition:
- Chlorothiazide: thiazide diuretic
- Reserpine: rauwolfia alkaloid, reduces central monoamine storage, historically used for hypertension
Clinical role: Historically aligned to step therapy and monotherapy simplification. In modern practice, many guidelines favor ACE inhibitors, ARBs, calcium-channel blockers, and other thiazide/thiazide-like diuretics with better tolerability and once-daily options.

What drives residual demand

Geography-dependent availability: Older combinations may persist where formularies, procurement contracts, or local sourcing keeps them on value lists.
Price sensitivity: The combination’s primary monetization lever is low-cost supply rather than differentiation.
Substitution pressure: Single agents and newer combination products exert competitive pull, especially where reserpine tolerability and adverse effect concerns impact prescribing.

Revenue fundamentals investors should model

Unit economics: gross margin compresses quickly due to multi-source generics.
Volume stability risk: demand declines over time as prescribers shift to newer agents.
Working-capital risk: older products can face irregular procurement cycles and distributor inventory resets.

What patents protect chlorothiazide-reserpine in the U.S. and major markets?

Featured snippet answer: For chlorothiazide-reserpine as a fixed-dose antihypertensive combination, the patent estate typically does not provide meaningful modern exclusivity in the U.S. beyond very old composition/use or formulation filings, and many market approvals run on generic pathways.

Typical patent landscape for older fixed-dose antihypertensives

Composition of matter: likely decades old at this stage.
Formulation patents: possible but generally expired if filed contemporaneously with the origin product.
Method-of-use patents: rarely sustain for fixed-dose legacy combinations once clinical standards evolve.

Practical investment implication

Expect few, if any, enforceable U.S. barriers that would block generic entry or sustain a brand-like premium.
Competitive advantage, if any, comes from supply reliability and channel relationships, not exclusivity.

(No specific patent identifiers are provided in the prompt; a complete, accurate patent mapping cannot be produced without a source dataset.)

When does chlorothiazide-reserpine lose exclusivity (U.S. and global)?

Featured snippet answer: For legacy fixed-dose combinations like chlorothiazide-reserpine, exclusivity generally has long since lapsed in the U.S., and the product behaves like a generic commodity where pricing is set by multi-source competition.

Exclusivity types investors track

U.S. Hatch-Waxman exclusivity (NCE/3-year/5-year/RX-to-OTC): not typically relevant for legacy combination products that predate modern exclusivity frameworks.
Patent term: if any patents remain, they are usually limited to minor formulation/device improvements and expire long before present day.
Regulatory exclusivity outside the U.S.: likewise tends to be expired for older molecules unless a local formulation or specific dosage strength was newly innovated.

What to model instead of “exclusivity”

Generic overhang timeline: how fast additional suppliers scale once a given market’s local tenders open.
Contracting risk: price resets that follow new supplier wins.
Regulatory friction: if approvals are tied to local inspections or specific manufacturing sites, delays can temporarily support margin.

What Orange Book status does chlorothiazide-reserpine have?

Featured snippet answer: Chlorothiazide-reserpine is expected to have an Orange Book profile consistent with older therapeutics where multiple generics are already available; brand exclusivity is usually not the dominant factor.

What an investor should extract from Orange Book profiles

Listed patent numbers and expiration dates
Drug product exclusivity type
Whether any patents are still “active” (unexpired) and in force
Whether fixed-dose combinations are treated as separate listings by strength

(A precise Orange Book status requires Orange Book listing data for the exact NDA/strength; none is provided.)

How many patents cover chlorothiazide-reserpine and which jurisdictions matter most?

Featured snippet answer: The number of enforceable patents covering a legacy fixed-dose hypertension combination is usually low today, and the dominant commercial reality is generic availability.

Jurisdictions investors typically prioritize

U.S.: Paragraph IV and settlement risk if a brand sponsor exists, but for legacy products this is usually minimal.
EU (EMA): depends on national member-state authorizations and whether any SPC or national patents remain.
UK: national patent and exclusivity effects depend on SPC/patent life.
Canada/Australia: generic entry timing can be driven by listed patents and market authorization schedules.

(No patent dataset is included, so a quantified count by jurisdiction cannot be stated accurately.)

Is there any Paragraph IV (IV) challenge risk for chlorothiazide-reserpine?

Featured snippet answer: Paragraph IV risk is generally low for legacy fixed-dose combinations without unexpired U.S. listed patents.

Why Paragraph IV matters even for low-exclusivity products

It can still affect seller’s market dynamics if:
- an Orange Book listing remains unexpired, or
- a brand sponsor licenses a “new” manufacturer and keeps an enforceable patent listed for a strength.

Investment screen

Identify whether any U.S. patents are still listed as of the current date.
If none exist, “IV risk” should not be modeled as a material event driver.

(Orange Book listing status and patent numbers are not provided.)

What generic entry risks exist for chlorothiazide-reserpine?

Featured snippet answer: Generic entry risk is structurally high because the product is older and likely widely manufacturable, with competitive pricing based on supplier count and tender mechanics.

What can still delay generic supply

Manufacturing validation: older formulations can still require site-specific approvals.
Stability and bioequivalence: fixed-dose combinations may require tighter formulation control.
Local regulatory capacity: inspection timelines can delay launches even after filings.

What can still support margins temporarily

Limited supplier network in a given geography.
Shortage dynamics: if certain sites retire lines or fail re-qualifications, single-source dynamics can briefly lift prices.

How does chlorothiazide-reserpine compare with modern antihypertensive regimens for competitive positioning?

Featured snippet answer: Modern antihypertensive standards emphasize agents with better tolerability profiles and predictable long-term adherence, which reduces the competitive advantage of older fixed-dose combinations.

Competitive substitution map

Thiazide-like diuretics: often preferred for similar efficacy with different tolerability expectations.
ACE inhibitors/ARBs: favored by comorbidity and guideline alignment.
Calcium-channel blockers: common in combination strategies.

Investment implication

Chlorothiazide-reserpine demand tends to be:
- price-driven,
- formulary-constrained,
- and at risk of continued substitution.

What formulation patents or manufacturing-process IP could still block generic manufacturing?

Featured snippet answer: For legacy fixed-dose products, process or formulation patents rarely remain enforceable long-term, but manufacturing-process rights can still create practical barriers via regulatory exclusivity tied to specific submissions.

Where “IP-like” barriers can persist

DMF and cross-referenced data: if certain excipients or manufacturing steps are tied to proprietary data packages.
Control strategy and impurity specifications: not always patent-protected, but they can create qualification friction.
Site-specific approvals: regulators can effectively restrict supply until inspections are cleared.

(No formulation/process IP is provided in the prompt; a patent-level assessment cannot be completed accurately.)

What regulatory status does chlorothiazide-reserpine have at the FDA (NDA/ANDA) and what pathway is used?

Featured snippet answer: Older fixed-dose antihypertensives typically enter via ANDA referencing older safety and effectiveness foundations, with bioequivalence requirements driven by formulation strength and route.

What to model in FDA context

ANDA filing volume by strength
Number of approved products (ANDA holders)
Whether there are “authorized generics”
Tender-driven discontinuations: older strengths can go dark depending on commercial demand.

(No FDA listing, NDA/ANDA identifiers, or approval strength data are provided.)

Which companies currently market chlorothiazide-reserpine, and how concentrated is supply?

Featured snippet answer: Market concentration is usually low for legacy antihypertensives because generic competition is common; concentration spikes only in geographies with limited local manufacturing capacity.

(No marketing company list is provided in the prompt; company-level fundamentals cannot be stated.)

What patent litigation affects chlorothiazide-reserpine, and are there settlement agreements on record?

Featured snippet answer: Litigation for chlorothiazide-reserpine is generally not a primary driver today because the product typically lacks ongoing U.S. patent exclusivity.

(No litigation records or court docket references are provided in the prompt; a specific litigation analysis cannot be produced accurately.)

How does licensing or co-promotion work for chlorothiazide-reserpine today?

Featured snippet answer: Licensing for legacy fixed-dose antihypertensives is usually about manufacturing rights and local distribution, not technology transfer protected by long-lived patents.

Typical deal structure in legacy portfolios

Geographic territory exclusivity tied to sales performance
Manufacturing supply agreements with quality systems as the key diligence
Regulatory ownership of product dossiers (DMF/CMC sponsorship)

(No specific licensing deals are provided in the prompt.)

Revenue exposure: what portion of value is tied to chlorothiazide-reserpine versus broader hypertension portfolios?

Featured snippet answer: In investment models, chlorothiazide-reserpine tends to be a small, price-sensitive contributor unless held in a geography where it remains a formulary staple.

How to build the revenue model

Price erosion curve: tie to generic entry and tender cycles.
Volume trend: incorporate continued substitution by modern regimens.
Supply availability risk: manufacturing compliance issues can create short-term volatility.

Key Takeaways

Exclusivity moat is likely minimal: chlorothiazide-reserpine is a legacy fixed-dose combination, and modern value drivers are channel access and supply chain efficiency, not patent life.
Generic pressure is structurally high: business outcomes usually track multi-source competition and tender mechanics.
Litigation catalysts are unlikely: absent unexpired listed patents, Paragraph IV and settlement dynamics are not major event risks.
Investment screen should shift from IP to operational execution: manufacturing robustness, cost of goods, dossier/regulatory ownership, and distributor contracts drive results more than patent strategy.

FAQs

Is chlorothiazide-reserpine still prescribed for hypertension in 2026?
What are the main adverse effect considerations that influence clinician adoption of resperpine-containing regimens?
Does chlorothiazide-reserpine have multiple strengths or fixed-dose variants that change generic eligibility by strength?
What manufacturing compliance factors most often cause stock-outs or discontinuations for legacy antihypertensive tablets?
How do tender-driven pricing dynamics typically affect legacy generic antihypertensives compared with newer branded launches?

References

(No external sources were cited because the prompt did not provide FDA/Orange Book identifiers, patent numbers, or litigation/market company data necessary for an accurate, data-backed Bloomberg-style analysis.)

US Patents:	0
Applicants:	1
NDAs:	2

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Summary for CHLOROTHIAZIDE-RESERPINE