Last Updated: August 3, 2026

RABEPRAZOLE SODIUM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Rabeprazole Sodium is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys, Lannett Co Inc, Pharmobedient, Rubicon Research, Teva Pharms Usa, and Torrent. and is included in ten NDAs.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rabeprazole Sodium

A generic version of RABEPRAZOLE SODIUM was approved as rabeprazole sodium by CHARTWELL RX on November 8th, 2013.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for RABEPRAZOLE SODIUM?
  • What are the global sales for RABEPRAZOLE SODIUM?
  • What is Average Wholesale Price for RABEPRAZOLE SODIUM?
Recent Clinical Trials for RABEPRAZOLE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nanjing First Hospital, Nanjing Medical UniversityNA
TenNor Therapeutics (Suzhou) LimitedPhase 3
Xuanzhu Biopharmaceutical Co., Ltd.Phase 2

See all RABEPRAZOLE SODIUM clinical trials

Pharmacology for RABEPRAZOLE SODIUM
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for RABEPRAZOLE SODIUM

US Patents and Regulatory Information for RABEPRAZOLE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 208644-001 Apr 24, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076885-001 Nov 8, 2013 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 078964-001 Nov 8, 2013 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rubicon Research RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204237-001 Nov 18, 2015 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal Pharms RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204179-001 Jul 31, 2015 AB RX 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 30, 2026

Rabeprazole Sodium market dynamics and financial trajectory (US, EU5, India and major export corridors)

Executive summary: Rabeprazole sodium is a mature, competitively priced proton pump inhibitor (PPI) with broad generic penetration across the US, EU and India. Revenue growth is now driven mainly by (1) population and GI-morbidity volume, (2) local formulary positioning, (3) mix shift into higher-strength tablets and combination products (rabeprazole + antibiotics where approved), and (4) supply-chain pricing dynamics. Patent protection is largely exhausted in most mature markets, so financial trajectory is dominated by generic price erosion and retailer/wholesaler contracting cycles rather than innovation.

Dimension Current market reality Financial impact
IP status Mature molecule; most platform protection long expired, with only limited formulation/process IP in pockets Revenue ceiling set by generic competition
Competitive landscape Multi-manufacturer generic PPIs; price often converges to low levels Margins compress; volumes matter more
Pricing drivers Tender-based contracting, parallel imports, channel stuffing risk, and currency effects in export markets Revenue can grow in units while value stays flat
Demand drivers Chronic GERD, dyspepsia, peptic ulcer disease; continued clinician use of PPIs Volume stability supports steady sell-through
Mix Strength mix and branded-to-generic shifts; combo products support value Value resilience versus pure rabeprazole monotherapy
Manufacturing constraints Supply reliability and API availability govern local pricing during shortages Short-term spikes possible, followed by normalization

How big is the rabeprazole sodium market and what is the growth outlook?

Featured snippet: Rabeprazole sodium is a mature PPI with growth tied to GI disease prevalence and regional access, not to new clinical differentiation. Expected market value trajectory is modest in mature markets due to ongoing generic price erosion.

Where demand concentrates

  • US: Generic-driven GI regimen coverage; rabeprazole competes with other PPIs (omeprazole, esomeprazole, pantoprazole, lansoprazole).
  • EU5 (DE, FR, IT, ES, UK): Similar competitive structure with tendering and formulary constraints.
  • India: High volume base; intense competition among generics and brand portfolios.
  • Export corridors: MENA, Latin America, Southeast Asia, and parts of Africa often show higher value volatility driven by contracting and supply disruptions.

What typically changes market value

  • Switching from branded to generic reduces ASP (average selling price).
  • Growth in units can be offset by price compression.
  • Combination products can lift value per prescription where supported by local indications and reimbursement.

What drives rabeprazole sodium pricing and contract outcomes in generic PPIs?

Featured snippet: Rabeprazole pricing is set by tender cycles, wholesaler/retailer reimbursement terms, and local competitive saturation, with occasional volatility from supply constraints.

Key pricing mechanics

  • Tendering and formulary placement: Public and semi-public tenders anchor pricing and set reference benchmarks.
  • Channel contracting: Hospital formularies and pharmacy chains use price laddering and substitution rules.
  • Parallel trade: In EU and UK contexts, parallel imports can pressure pricing.
  • API and intermediate sourcing: Tight supply windows in key intermediates can cause brief value uplifts.

Competitive set substitution effects

Rabeprazole competes on “class equivalence” with other PPIs. Substitution policies often reduce brand differentiation, pushing players toward:

  • price-volume strategies
  • contract manufacturing scale advantages
  • combination-product portfolios

How does rabeprazole sodium compare with other PPIs on commercial trajectory?

Featured snippet: In mature PPIs, commercial performance tends to converge as generics expand. Revenue is more sensitive to unit volume and mix than to pricing power.

Relative commercial dynamics

  • Omeprazole and pantoprazole: Larger installed base and broader guideline adoption can stabilize volumes, but generics also saturate these classes.
  • Esomeprazole and lansoprazole: Some markets show differentiated mix (capsule/tablet ecosystems) that can slow price erosion relative to rabeprazole.
  • Rabeprazole: Often strong in niche brand footprints and certain geographies, but faces aggressive price convergence once multiple suppliers establish.

When do rabeprazole sodium revenues peak in a market after generic entry?

Featured snippet: Revenue typically peaks shortly before major generic proliferation then decays as additional suppliers win tenders and expand distribution.

Generic entry pattern (typical for mature PPIs)

  1. Pre-entry: Higher branded or early generic pricing, limited competition.
  2. First wave: Several generic entrants compress ASP; units rise but value growth slows.
  3. Second wave: Broad shelf placement and tender rollovers; further ASP decline.
  4. Normalization: Value stabilizes at low ASP while volume may continue rising slowly with population and GI prevalence.

What can delay decay

  • Mix improvements via combination products.
  • Regional formulary decisions that favor specific supplier contracts.
  • Local shortages in API or finished goods that temporarily raise prices.

What patent and exclusivity dynamics matter for rabeprazole sodium financials?

Featured snippet: The molecule’s market is largely driven by generic pricing and supply rather than active exclusivity in mature jurisdictions.

Where IP can still matter commercially

Even after main substance patents expire, residual IP pockets can influence:

  • certain formulations (e.g., enteric coatings, controlled release elements)
  • manufacturing processes and polymorph control
  • combination products and specific dosage-strength ecosystems

In practice, these pockets rarely prevent generic class competition long term, but they can:

  • sustain a short-term margin advantage for specific suppliers
  • shape which generic entrants can launch particular SKUs cleanly

What is the regulatory and FDA trajectory for rabeprazole sodium in the US?

Featured snippet: US distribution is primarily generic; financial performance is determined by ANDA-based competition and contracting rather than by regulatory barriers.

ANDA and market access

  • Rabeprazole sodium is an established oral PPI.
  • In the US, generic availability means the primary regulatory constraints are not development feasibility but bioequivalence and manufacturing compliance to keep market supply intact.

Substitution behavior

  • Pharmacy substitution policies and payer preferences influence which supplier wins repeat fills.
  • Product packaging and strength availability can influence practical switching rates.

What is the Orange Book status for rabeprazole sodium and how does it affect generics?

Featured snippet: Orange Book listings for rabeprazole are not expected to create broad ongoing exclusivity; the commercial market is already generic.

Commercial impact of Orange Book

  • If any Orange Book-related patents exist in a specific SKU, they tend to delay specific launches rather than stop class-wide generic pressure.
  • Financial outcomes for manufacturers are usually decided by tender execution and supply scale more than by remaining exclusivity.

How do formulation and combination products change the rabeprazole sodium revenue mix?

Featured snippet: Revenue durability comes from product mix, especially combination products and strength formulations that sustain differentiation in local channels.

Combination-product pathways

  • Rabeprazole used in GI regimens where local approvals and reimbursement support multi-drug dosing.
  • Commercially, combinations can lift:
    • effective selling price per patient course
    • loyalty via regimen bundling
    • switching costs for pharmacies and wholesalers

Dosage-form and strength mix

  • Different tablet strengths and packaging formats can change:
    • tender eligibility
    • unit economics
    • patient adherence patterns

Which companies are major participants in rabeprazole sodium and how does that shape margins?

Featured snippet: Rabeprazole sodium has a fragmented generic supply base; margins compress as supply broadens and buyers standardize on lowest cost.

Typical participant types

  • Large generic multinationals with scale in API-to-finished-goods supply
  • Regional Indian manufacturers exporting to multiple countries
  • Local distributors that win tenders through relationship-based contracting

Margin implications

  • Scale reduces unit costs but does not prevent price compression.
  • Marketing intensity and packaging can matter in branded or semi-branded markets, but generic rails dominate.

What commercial risks matter most for rabeprazole sodium financial trajectory?

Featured snippet: The biggest risks are pricing compression, supply chain disruption, and sudden tender resets that change contract winners.

Top risk categories

  1. Price erosion and competitive undercutting
    • Continuous entry pressure drives ASP down.
  2. Tender volatility
    • A single contract loss can materially affect regional revenue.
  3. Supply interruptions
    • QC failures, API shortages, or manufacturing downtime can create pricing spikes then sudden revenue gaps.
  4. Regulatory compliance events
    • GMP actions can restrict shipments and force temporary reallocation to other SKUs.
  5. Currency and trade barriers
    • Export revenue can swing with exchange rates and customs/tariffs.

How does rabeprazole sodium revenue typically split between volume and ASP?

Featured snippet: In mature generic markets, volume growth rarely offsets ASP declines; revenue growth tends to be limited unless mix upgrades occur.

Typical pattern in generic PPIs

  • Unit volumes track GI prevalence and local access expansion.
  • ASP declines follow competitive saturation and tender renegotiations.
  • Net revenue stabilizes at low single-digit growth in many stable markets, or flat value with modest unit growth.

Key market timeline: how rabeprazole sodium financial trajectory evolves across generic lifecycle

Featured snippet: Expect a multi-year decline curve after major generic entry, with intermittent disruptions from supply and tender resets.

Lifecycle stage Market behavior Financial profile
Early generic expansion ASP drops, units rise Revenue may grow briefly in value but slows
Broad saturation Many suppliers win shelf and tenders Revenue flattening; margin erosion
Normalized equilibrium Stable low ASP; volume growth modest Value stable; focus on cost leadership
Supply-driven spikes Short shortages raise local prices Temporary value lift, then reverts
Mix upgrade Combination and preferred strengths gain share Value resilience vs class benchmark

What generic launch scenarios create entry risks for rabeprazole sodium competitors?

Featured snippet: Entry risk is highest when incumbents have strong tender relationships and supply reliability; lowest when API capacity is constrained and buyers seek qualified alternates.

Scenario mapping

  • High entry friction
    • incumbent holds multiple tender contracts
    • incumbent has stable packaging supply and faster lead times
    • local distributor relationships favor incumbent
  • Lower friction
    • incumbent supply constrained or QC action history
    • API availability improves while tenders open wide eligibility
    • buyer seeks cost reduction with multiple qualification routes

Key takeaways

  • Rabeprazole sodium is a mature generic PPI where financial trajectory is governed by generic pricing, tender contracting, and product mix.
  • Revenue growth is usually volume-led and modest in value because ASP declines with competitive saturation.
  • Combination-product mix and strength/packaging differentiation are the main levers for sustaining value.
  • Primary risks are contract losses, pricing compression, and supply chain disruptions rather than IP-driven entry blocks.
  • The commercial outlook is stable but low-growth in mature markets, with more volatility in regions where tender and supply conditions shift faster.

FAQs

  1. Why does rabeprazole sodium often track class-wide PPI pricing rather than drug-specific pricing?
  2. How do combination rabeprazole regimens change payer reimbursement and pharmacy buying behavior?
  3. What tends to happen to ASP in mature PPIs after a new generic supplier qualifies for tenders?
  4. Which supply chain failures most often disrupt rabeprazole availability and create temporary pricing spikes?
  5. How do currency swings and export compliance affect rabeprazole sodium net revenue for exporters?

References

(No sources were provided in the prompt, and no citations were included because the required market data, regulatory listings, and financial figures are not present in the supplied material.)

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.