Last Updated: July 22, 2026

PREXXARTAN Drug Patent Profile


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When do Prexxartan patents expire, and when can generic versions of Prexxartan launch?

Prexxartan is a drug marketed by Carmel Biosciences and is included in one NDA.

The generic ingredient in PREXXARTAN is valsartan. There are forty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the valsartan profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prexxartan

A generic version of PREXXARTAN was approved as valsartan by OHM LABS INC on June 26th, 2014.

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Questions you can ask:
  • What is the 5 year forecast for PREXXARTAN?
  • What are the global sales for PREXXARTAN?
  • What is Average Wholesale Price for PREXXARTAN?
Summary for PREXXARTAN
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 114
Patent Applications: 3,431
What excipients (inactive ingredients) are in PREXXARTAN?PREXXARTAN excipients list
DailyMed Link:PREXXARTAN at DailyMed
Pharmacology for PREXXARTAN

US Patents and Regulatory Information for PREXXARTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Carmel Biosciences PREXXARTAN valsartan SOLUTION;ORAL 209139-001 Dec 19, 2017 DISCN Yes 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 18, 2026

PREXXARTAN market dynamics and financial trajectory: launch drivers, payer uptake, pricing pressure, and patent-to-generic risk

Executive summary: PREXXARTAN’s market trajectory is determined by three linked variables: (1) how quickly payers move it from prior authorization to broad formulary access, (2) whether its price and rebates stay inside the “affordability” band set by competing ARB-class agents, and (3) the timing and strength of its exclusivity and patent estate versus generic or follow-on entrants. The drug’s financial path cannot be mapped to actionable forecasts without a verifiable FDA product identity, marketed strength/formulation, and credible sources for revenue, pricing, and exclusivity status.

What is PREXXARTAN and where is it marketed?

Answer: No validated product dossier or FDA-tracked identity for “PREXXARTAN” is provided here, so market size, geography, launch status, and revenue scope cannot be grounded in specific regulatory or payer facts.

Which active ingredient and salt form does “PREXXARTAN” correspond to?

A market dynamics analysis depends on mapping the trade name to the underlying active moiety, dosage form, and strength, because competitors and exclusivity differ by:

  • active ingredient (and whether it is an ARB, ARNI, or other class),
  • salt form (bioequivalence and generic design-around),
  • dosage form (tablet vs combination vs extended release),
  • line of therapy indications (label scope drives payer coverage).

What is the FDA pathway and Orange Book positioning?

Financial trajectory hinges on:

  • whether PREXXARTAN is an NDA/BLA with an Orange Book listing,
  • exclusivity type (NCE, 3-year, 5-year, pediatric, etc.),
  • patent listing granularity (drug product, method of use, manufacturing).

Without a traceable Orange Book entry, there is no defensible exclusivity or generic entry timeline.

How do competitors in the ARB class shape PREXXARTAN pricing and uptake?

Answer: Competitor ARB class dynamics drive PREXXARTAN’s net price via formulary design and rebate pressure. The direction of that pressure depends on whether PREXXARTAN is positioned as:

  • a lower-cost interchangeable ARB,
  • a differentiated ARB with clinical advantages that justify tier placement,
  • or a combination product that changes payer economics.

What formulary tier does PREXXARTAN need to reach to sustain growth?

For chronic cardiovascular drugs, sustained revenue typically requires:

  • movement to preferred brand or managed tier,
  • stable prior authorization criteria,
  • and reduced step therapy barriers.

Those levers translate into financial outcomes only when PREXXARTAN’s payer history is known (PBM coverage changes, medical policy adoption, and rebate benchmarks).

What drives switching from competing ARBs?

Switching economics usually depends on:

  • label breadth (hypertension, heart failure, diabetic nephropathy),
  • BP lowering profile and tolerability claims,
  • co-pay assistance and contracting terms,
  • and whether members are stable on existing therapy.

A financial trajectory model requires known utilization and claims share data for PREXXARTAN, which is not provided.

When does PREXXARTAN face generic or follow-on entry risk?

Answer: Generic risk is a function of FDA exclusivity and patent expiration plus Paragraph IV litigation outcomes. No Orange Book patent or exclusivity data for PREXXARTAN is provided, so timing of loss of exclusivity and first potential generic launch cannot be stated.

What exclusivity milestones matter most for revenue?

For brand trajectory, the key milestones are:

  • earliest patent expiration (independent of FDA exclusivity),
  • 180-day exclusivity eligibility for first ANDA filer,
  • pediatric exclusivity extensions,
  • and settlement terms that delay or accelerate market entry.

No such milestones can be mapped without an Orange Book and litigation record for the specific PREXXARTAN product.

What Paragraph IV landscape would predict the financial inflection?

Paragraph IV filings typically create:

  • a near-term revenue protection period via litigation uncertainty,
  • then sharp net revenue erosion once ANDA supply reaches contracted channels.

But the presence, number, and status of ANDA Paragraph IV challenges for PREXXARTAN cannot be asserted without sourced docket data.

What is the Orange Book status of PREXXARTAN and how strong is the patent estate?

Answer: No Orange Book status, patent numbers, expiry dates, or listed exclusivity periods for PREXXARTAN are supplied, so patent strength cannot be measured.

Which patent types usually govern market protection for small-molecule brands?

Financial exposure usually correlates with whether protection is concentrated in:

  • drug substance vs drug product patents,
  • method-of-use patents tied to claims that matter commercially,
  • manufacturing or formulation patents that block “non-infringing” designs.

The patent estate strength assessment requires a list of Orange Book patents with their claim scopes, expiry dates, and jurisdiction.

What generic entry risks exist for PREXXARTAN and how fast could volume shift?

Answer: Rapid volume shift is plausible once generics are approved and contracted, but the exact speed depends on:

  • number of ANDA entrants,
  • contracting intensity (PBM switching algorithms),
  • and whether pharmacists can substitute without clinical barriers.

No entry timetable, entrants, or substitution constraints are available in the provided materials.

What replacement scenario is most likely: single generic vs multi-generic?

  • Single-generic first waves can cap early erosion through contracting leverage.
  • Multi-generic entry increases price competition, accelerates erosion, and compresses net revenue.

Without data on potential ANDA filers and regulatory status, the scenario cannot be stated.

How do settlement agreements and patent litigation affect PREXXARTAN revenue?

Answer: Litigation and settlements often determine:

  • “design-around” freedom for the first generic,
  • launch delay windows,
  • and whether at-risk supply occurs.

No PREXXARTAN litigation dockets, infringement allegations, or settlement terms are supplied, so revenue impact cannot be quantified.

What litigation outcomes typically change the financial curve?

  • early adverse rulings can trigger accelerated generic launch,
  • protracted litigation can delay entry but may reduce brand marketing intensity,
  • settlements can trade payment terms for launch delays, controlling erosion pace.

These outcomes are not determinable for PREXXARTAN without case-level data.

What is PREXXARTAN’s FDA regulatory status and what does it mean for commercialization?

Answer: FDA status is not provided, so the analysis cannot connect regulatory milestones to commercialization signals such as:

  • launch timing,
  • label expansion,
  • or market exclusivity retention.

What label elements drive payer coverage?

Payer uptake depends on:

  • indication alignment with covered populations,
  • clinical guideline concordance,
  • and use restrictions.

A label-by-indication coverage analysis requires the actual PREXXARTAN label.

How does PREXXARTAN compare with competing ARBs on lifecycle risk and growth resilience?

Answer: A direct comparison requires competitor-specific and PREXXARTAN-specific data on:

  • exclusivity timelines,
  • price and net price trajectory,
  • utilization trends,
  • and patent estate scope.

Those inputs are not available for PREXXARTAN in the provided prompt.

What comparison framework is used for financial modeling?

A credible comparison is built from:

  • earliest exclusivity end dates,
  • patent expiry clustering,
  • likelihood of Paragraph IV challenges,
  • and contracting strategy under PBM negotiations.

No such dataset is supplied.

What commercialization economics determine PREXXARTAN net revenue trajectory?

Answer: For chronic small molecules, net revenue is typically governed by:

  • WAC-to-net discounting,
  • rebate intensity by payer segment,
  • copay program spend (if any),
  • and chargebacks under contracting.

But the prompt does not include:

  • list price,
  • net price,
  • rebate rates,
  • or payer mix.

Key Takeaways

  • PREXXARTAN’s market dynamics and financial trajectory are driven by exclusivity-to-generic timing, payer formulary execution, and net price management against ARB competitors.
  • No verifiable FDA identity, Orange Book status, patent listing, exclusivity timeline, or revenue and pricing data for PREXXARTAN is included in the provided information, so an actionable financial trajectory cannot be produced from hard facts.

FAQs

  1. What does Orange Book listing determine for PREXXARTAN generic launch timing?
  2. How do PBM formulary moves typically impact net revenue for brand ARBs like PREXXARTAN?
  3. What indicators predict whether Paragraph IV challenges will erode PREXXARTAN revenue quickly?
  4. How do patent settlement terms usually affect branded small-molecule revenue curves?
  5. What commercial signals track PREXXARTAN utilization growth versus competitors?

References

  1. No sources were provided in the prompt to cite.

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