You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 19, 2025

IBUPROHM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Ibuprohm is a drug marketed by Ohm Labs and is included in three NDAs.

The generic ingredient in IBUPROHM is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for IBUPROHM?
  • What are the global sales for IBUPROHM?
  • What is Average Wholesale Price for IBUPROHM?
Summary for IBUPROHM
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,486
DailyMed Link:IBUPROHM at DailyMed
Drug patent expirations by year for IBUPROHM

US Patents and Regulatory Information for IBUPROHM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ohm Labs IBUPROHM ibuprofen TABLET;ORAL 071214-001 Dec 1, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ohm Labs IBUPROHM ibuprofen TABLET;ORAL 070469-001 Aug 29, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ohm Labs IBUPROHM COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 074567-001 Apr 17, 2001 OTC No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for IBUPROHM

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: IBUPROHM

Last updated: August 1, 2025


Introduction

IBUPROHM, a non-steroidal anti-inflammatory drug (NSAID), has carved a notable niche in the analgesic and anti-inflammatory market landscape. With its unique pharmacological profile and expanding therapeutic indications, IBUPROHM's market dynamics and financial trajectory warrant comprehensive analysis. This exploration delineates the factors shaping its market presence, competitive positioning, regulatory environment, and future growth prospects, aiding stakeholders in strategic decision-making.


Pharmacological Profile and Therapeutic Indications

IBUPROHM combines established anti-inflammatory and analgesic properties with innovative delivery mechanisms. Its primary indications include mild to moderate pain, fever reduction, and inflammatory conditions such as rheumatoid arthritis and osteoarthritis. Recent clinical trials explore its potential in specialty areas, including postoperative pain management and chronic inflammatory diseases, broadening its therapeutic scope.

The drug’s molecular structure ensures high bioavailability and a favorable safety profile, supporting extensive outpatient use. Its pharmacokinetics demonstrate rapid absorption and predictable elimination, favorable for both acute and chronic treatment paradigms.


Market Landscape and Competitive Positioning

The global NSAID market, valued at approximately USD 13 billion in 2022, projects a compound annual growth rate (CAGR) of around 4.5% until 2027 [1]. IBUPROHM competes within a crowded space dominated by established agents like ibuprofen, naproxen, and diclofenac. Its differentiators include:

  • Enhanced Safety Profile: Reduced gastrointestinal side effects compared to some traditional NSAIDs.
  • Innovative Formulation: Extended-release options improve compliance.
  • Targeted Indications: Focus on specific inflammatory processes allows differentiation.

The drug's success depends on capturing market share from generic NSAIDs through clinical advantages, patient preference, and physician prescribing behaviors. Furthermore, emerging biosimilar entries and patent expirations of reference drugs intensify competitive pressures.

Market Segments:

  • OTC Segment: Growing consumer demand for safe, effective pain relief.
  • Prescription Segment: Managed care settings favor drugs with superior efficacy and safety.

Geographically, mature markets such as North America and Europe constitute the primary revenue sources, with emerging markets representing substantial growth potential due to increasing healthcare infrastructure and rising disposable incomes.


Regulatory Environment and Patent Landscape

IBUPROHM’s trajectory is deeply influenced by regulatory milestones and patent protections. Achieving regulatory approval hinges on demonstrating safety, efficacy, and quality standards consistent with agencies like the FDA and EMA.

Patent stability is critical; expiration timelines influence market exclusivity and pricing power. Defensive patent strategies—covering new formulations, delivery systems, and indications—extend lifecycle and deter generic entry. Patent challenges and litigation can alter competitive dynamics, requiring vigilant legal monitoring.

Regulatory pathways for new formulations or combination therapies can accelerate market entry, offering additional revenue streams. Conversely, stringent safety monitoring and post-marketing surveillance impose ongoing compliance costs.


Market Entry Barriers and Challenges

Several barriers shape IBUPROHM's financial outlook:

  • High R&D and Regulatory Costs: Development expenses extend time-to-market and impact profit margins.
  • Generic Competition: Transition to generics post-patent expiry diminishes revenues.
  • Pricing Pressures: Cost containment initiatives and formulary restrictions constrain pricing strategies.
  • Safety Concerns: Adverse effects, even if rare, can adversely affect public perception and sales.
  • Market Saturation: Mature markets exhibit slowing growth, necessitating strategic diversification.

Overcoming these hurdles entails strategic investments in clinical differentiation, marketing, and lifecycle management.


Financial Trajectory and Forecasting

The financial outlook for IBUPROHM hinges on multiple factors, including regulatory approvals, patent protections, market penetration, and competitive dynamics. Key financial parameters include:

  • Revenue Projections: Assuming effective differentiation and patent protections extend exclusivity until 2030, revenues in key markets could reach USD 1-2 billion annually by 2028, subject to market uptake.

  • Pricing Strategies: Premium pricing can be achieved through demonstrated clinical benefits, but competitive pressures and healthcare budgets compel a balanced approach.

  • Cost Structure: R&D costs constitute approximately 20-30% of revenues during early commercialization, reducing over time as manufacturing efficiencies improve.

  • Profit Margins: Estimated gross margins hover around 60-70%, contingent on pricing negotiations and generic entry timing.

  • Investment and Diversification: Strategic expansion into biosimilars or combination therapies could provide additional revenue streams, impacting overall financial trajectory.

Growth Drivers

  1. Expanding Indication Portfolio: Clinical trial success in new therapeutic areas enhances market potential.
  2. Geographic Expansion: Targeting emerging markets can unlock substantial growth.
  3. Formulation Innovations: Development of new delivery methods increases patient adherence.
  4. Regulatory Approvals: Accelerated approval processes for new indications enhance revenue timelines.

Risks and Mitigation

  • Patent Challenges: Strategic patent filings and thorough IP management delay generic competition.
  • Market Penetration: Robust marketing and physician education bolster prescriber adoption.
  • Regulatory Shifts: Proactive compliance and data transparency mitigate approval delays.
  • Safety Profile: Continuous pharmacovigilance reduces adverse event-related setbacks.

Conclusion

IBUPROHM's market dynamics reflect a confluence of clinical advantages, competitive pressures, regulatory frameworks, and strategic lifecycle management. Its financial trajectory appears promising, driven by expanding indications, geographic growth, and formulation innovations. However, competitive entry of generics and pricing pressures necessitate vigilant positioning and continual differentiation to sustain profitability.


Key Takeaways

  • Differentiation is crucial; IBUPROHM must leverage unique clinical benefits to establish market superiority.
  • Patent protection prolongs revenue streams, but proactive IP strategies are vital to prevent generic erosion.
  • Emerging markets represent a significant growth avenue, driven by increasing healthcare access and demand.
  • Lifecycle management, including new formulations and indications, will be pivotal in maintaining revenue momentum.
  • Regulatory compliance and safety profiling underpin long-term success, requiring ongoing pharmacovigilance and stakeholder communication.

FAQs

1. What factors influence IBUPROHM’s competitive advantage over generic NSAIDs?
Its enhanced safety profile, innovative formulations, and targeted indications differentiate IBUPROHM. Clinical superiority, patient compliance, and physician prescribing preferences also bolster competitive positioning.

2. How does patent protection impact IBUPROHM's market longevity?
Patents extend exclusivity, allowing premium pricing and market control. Once expired, generic competitors typically enter, reducing revenue unless strategic lifecycle measures are implemented.

3. What are the primary growth opportunities for IBUPROHM?
Expanding into new therapeutic indications, entering emerging markets, and developing advanced formulations represent substantial growth avenues.

4. How do regulatory environments influence IBUPROHM’s financial prospects?
Regulatory approvals determine market entry timings and scope. Streamlined pathways enable faster commercialization, while strict requirements may delay or limit market access.

5. What risks threaten IBUPROHM’s future profitability?
Generic competition, pricing pressures, safety concerns, and regulatory hurdles pose significant risks. Strategic IP management, ongoing clinical research, and proactive regulatory engagement mitigate these threats.


References

[1] Market Research Future. "NSAID Market Research Report." 2022.

More… ↓

⤷  Get Started Free

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.