Last Updated: August 9, 2026

Ipsen Company Profile


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Summary for Ipsen
International Patents:376
US Patents:48
Tradenames:5
Ingredients:5
NDAs:5

Drugs and US Patents for Ipsen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559-004 Aug 16, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 RX Yes No 11,583,539 ⤷  Start Trial ⤷  Start Trial
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-003 Jul 20, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Ipsen BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 RX Yes Yes 9,694,018 ⤷  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

Expired US Patents for Ipsen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipsen IQIRVO elafibranor TABLET;ORAL 218860-001 Jun 10, 2024 7,632,870 ⤷  Start Trial
Ipsen ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 8,703,181 ⤷  Start Trial
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 7,132,416 ⤷  Start Trial
Ipsen ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 10,722,508 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Ipsen Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3400944 LUC00242 Luxembourg ⤷  Start Trial PRODUCT NAME: ODEVIXIBAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BYLVAY); AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719
3400944 2021C/554 Belgium ⤷  Start Trial PRODUCT NAME: ODEVIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719
3435996 50008/2025 Austria ⤷  Start Trial PRODUCT NAME: ELAFIBRANOR UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/24/1855 (MITTEILUNG) 20240923
1746976 SPC/GB17/043 United Kingdom ⤷  Start Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Last updated: June 26, 2026

Ipsen Competitive Landscape Analysis: Market Position, Strengths & Strategic Insights

Ipsen is a mid-to-large cap specialty biopharma with concentrated exposure to oncology and rare disease, plus meaningful marketed revenue from neuromodulation (Dysport) and select growth platforms (notably Parkinson’s/neuromuscular and oncology pipeline). Its competitive position is shaped by (i) IP-led portfolio clustering (tied to branded biologics/specialty medicines), (ii) manufacturing and supply complexity for injectables and antibody products, and (iii) a deal and acquisition strategy aimed at adding late-stage assets while extending lifecycle protection.

Where does Ipsen rank in the pharmaceutical market by revenue and growth?

Ipsen operates at a tier where brand and specialty revenue can outpace large-cap peers that depend more on primary care and vaccines. The competitive set is defined less by “top-line size” and more by:

  • Specialty product portfolio breadth (multiple therapeutic franchises across oncology, neuromuscular, and rare disease)
  • IP longevity through patent estates around biologics, formulations, and manufacturing/process
  • Selective geographic footprint in sales, with execution dependent on reimbursement and tendering systems

How does Ipsen’s market positioning compare with other specialty biopharma (mid-cap)?

Ipsen’s closest competitive comparisons typically include specialty-focused biopharma companies with injectables and oncology/rare disease focus, including Radius Health-era legacy models, Horizon-style neuromuscular competitors, and rare disease peers. In practice, competitive pressure comes from:

  • Branded-to-generic transitions in older small-molecule categories (where Ipsen has less direct exposure)
  • Biosimilar entry risks (for monoclonals and protein therapeutics where patents allow)
  • Price pressure in Europe driven by reference pricing and HTA decisions

What is Ipsen’s product portfolio structure and how is it defended by IP?

Ipsen’s portfolio is dominated by branded specialty medicines, which generally carry stronger IP defensibility than commodity generics. Key franchises typically include:

  • Neuromodulation (Dysport, abobotulinumtoxinA)
  • Oncology (multiple candidates and marketed assets across solid tumors)
  • Rare disease and urology or endocrine-adjacent indications (depending on the current commercialization mix)
  • Targeted biologics and specialty small molecules where lifecycle protection can include formulations, dosing regimens, and manufacturing process

Which Ipsen brands drive revenue exposure?

Ipsen’s revenue exposure is concentrated in a handful of branded products. The competitive risk profile differs by category:

  • Botulinum toxin: competitive pressure from alternative botulinum toxin brands, conversion at national tender prices, and clinician preference.
  • Monoclonals: competitive pressure from biosimilar entrants and payer contracting.

How strong is Ipsen’s patent estate for its marketed products?

Ipsen’s patent defensibility is a function of:

  • Whether the core active ingredient patents are still within term
  • Whether secondary patents remain in force (formulations, dosing regimens, device-related delivery, stable compositions, and manufacturing processes)
  • Whether Orange Book-style listing exists for small molecules and whether the US FDA pathway creates leverage via exclusivity and patent listing

For injectable biologics, the strongest barriers tend to come from:

  • Composition of matter and formulation patents
  • Process patents on manufacturing and characterization
  • Specific antibody/epitope and method-of-use patents that narrow biosimilar equivalence arguments

What patents protect Ipsen’s neuromodulation products?

Botulinum toxin products typically have:

  • Composition and toxin preparation process protection
  • Formulation and reconstitution stability patents
  • Indication-specific method-of-use and dosing regimen patents

Competitive entries from other toxin manufacturers face clinical switching barriers, but the key economic barrier is tendering and national contract pricing.

What patents protect Ipsen’s biologics and oncology assets?

Oncology and antibody programs often have multi-layer patent estates that include:

  • Antibody composition of matter
  • Binding/epitope patents
  • Method-of-use and combination regimens
  • Manufacturing, cell line, and process controls
  • Formulation and administration options

The defensibility varies with how tightly claims map to the eventual approved label and how many “work-around” options exist in development.

When does Ipsen lose exclusivity and when are biosimilar or generic entry risks highest?

Exclusivity timelines are driven by:

  • Core patent expiration for active ingredient and high-level composition protection
  • Secondary patent term via formulation and method-of-use claims
  • Regulatory exclusivity blocks in the US (for new biologics and new molecular entities) where applicable
  • Settlement outcomes that can move launch dates even when patents expire

What is the typical Ipsen risk window by product class?

  • Biologics: risk tends to rise in the 24 to 60 months before earliest core patent expiration, with uncertainty around biosimilar litigation timelines.
  • Botulinum toxin: risk is less about generic replacement and more about contracting dynamics and label/dosing equivalence; losses can happen when pricing pressure accelerates and tenders open.

What patent litigation affects Ipsen, and how does it shape competitive timelines?

Patent litigation is a practical variable that can:

  • Delay generic/biosimilar approvals
  • Change the effective launch date through settlement-to-launch strategies
  • Increase development cost and enforce switching delays via safety monitoring and post-marketing requirements

What Paragraph IV or biosimilar litigation patterns are most relevant to Ipsen?

When Ipsen products include small molecules with Orange Book listings, Paragraph IV challenges can force litigation. When products are biologics, biosimilar litigation and reference product exclusivity control entry timing.

In general, the competitive impact is highest when:

  • An intended entrant is near approval readiness
  • Ipsen’s claims include multiple independent limitations
  • Settlements lock in a time-bounded launch

What is the Orange Book status of Ipsen products, and what does it imply for generic entry?

For a generic entry risk assessment in the US, the Orange Book matters when:

  • Ipsen has listed patents tied to the approved drug and NDA/BLA
  • The entrant can trigger a Paragraph IV challenge
  • Patent listings include method-of-use and formulation patents that can be argued as weak or non-infringing

Which Ipsen assets have the most generic entry pressure?

The generic and biosimilar risk is strongest for products where:

  • Core patent protection is near-term
  • Label and dosing are widely replicable
  • Manufacturing work-around is plausible
  • Litigation history shows predictable outcomes

For specialty injectables like botulinum toxins, generic small-molecule-style entry is not the direct threat; instead, competitive entry comes from other branded toxins and, for biologics, biosimilars.

How do Ipsen’s competitive strengths compare to major rivals?

Ipsen strengths that tend to matter commercially

  • Execution in injectables: stable supply, label-specific dosing, and consistent manufacturing controls
  • Portfolio mix: multiple franchises reduces reliance on one pipeline binary event
  • Lifecycle management: a patenting approach covering formulation and method-of-use reduces rapid follow-on entry risk
  • Deal discipline: adding late-stage assets to reduce pipeline volatility

Ipsen weaknesses that competitors exploit

  • Concentrated franchise exposure: if a key tender contract or payer decision turns, revenue can shift quickly
  • Patent noise risk: large estates increase administrative complexity and can dilute focus if too many secondary patents are asserted
  • Competitive switching: in neuromodulation, clinician preference and payer contracting can outweigh marginal efficacy differences

How does Dysport compare with competing botulinum toxin products in competitive positioning?

Botulinum toxin competitive dynamics are dominated by:

  • Product labeling and approved dosing conversion practices
  • Reimbursement and tender structures by geography
  • Clinical education programs
  • Real-world switching patterns and perceived durability

Competitive comparison dimensions

  • Efficacy and onset narratives in clinical practice
  • Unit dosing equivalence and pricing per treatment cycle
  • Market access strategy: contracting, rebates, and tender bids

Which Ipsen pipeline bets are most likely to reshape competitive positioning?

Pipeline impact is strongest when programs are:

  • Near regulatory review or late-stage
  • Strategically adjacent to existing sales channels and field teams
  • Designed to protect against biosimilar or generic encroachment via differentiated mechanism or combination regimens

Competitive advantage increases when:

  • The label can be expanded into broader patient populations
  • Combination regimens produce payer-friendly value arguments
  • IP estates cover multiple lines of therapy

What manufacturing and regulatory/IP barriers defend Ipsen’s competitive position?

For specialty injectables and biologics, competitive entry is often constrained by:

  • Manufacturing validation complexity
  • Analytical comparability and stability requirements
  • Time to demonstrate consistent potency, purity, and product quality
  • Regulatory inspection readiness and supply chain robustness

Even when patent barriers weaken, practical readiness can delay competitor launches, especially for biologics that require extensive similarity packages.

What strategic licensing and partnership approach does Ipsen use to build or defend market position?

Ipsen typically uses partnerships to:

  • Acquire late-stage assets and reduce R&D risk
  • Share development cost and access regional regulatory expertise
  • Enhance IP positioning via combination or platform extensions

From a competitive standpoint, the key commercial signal is whether deals bring:

  • Near-term launch assets that plug revenue gaps
  • Platform extensions that expand patient share in existing franchises
  • IP-rich assets with clear exclusivity and patent coverage

Which geographic markets drive the highest competitive leverage for Ipsen?

Ipsen’s competitive leverage is shaped by:

  • HTA and reimbursement frameworks in Europe
  • Tendering and price controls for injectables
  • Hospital formularies for oncology and specialty medicines

In many specialty categories, the earliest adoption advantage in the largest payer systems can compound through clinician familiarity and procurement routines.

Key Takeaways

  • Ipsen’s competitive position is built on specialty franchises with IP-heavy lifecycles, especially for injectables and oncology/rare disease assets.
  • Competitive threats are product-class-specific: neuromodulation faces branded-to-branded and tender-driven pressure; biologics face biosimilar risk driven by patent term and litigation/settlement timing.
  • The most actionable defense factors are patent estate layering (formulation, method-of-use, process) and manufacturing readiness, which together can delay or deter follow-on entry even when core patents weaken.
  • Market position shifts can be driven as much by payer contracting and tender outcomes as by clinical differentiation.

FAQs

  1. How do biosimilar launch settlements typically affect Ipsen’s market share for monoclonal antibodies?
  2. What patent claim types most often determine whether a biosimilar can be launched against an Ipsen biologic?
  3. How does tender pricing change competitive dynamics for botulinum toxin products like Dysport?
  4. Which Ipsen pipeline stages are most correlated with sustained revenue growth versus volatility?
  5. What manufacturing bottlenecks most frequently delay follow-on entrants for specialty injectables?

References

  1. No sources were provided in the prompt, and no company- or product-specific regulatory or patent datasets were supplied.

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