Last Updated: May 10, 2026

Alkermes Inc Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Alkermes Inc
International Patents:211
US Patents:34
Tradenames:3
Ingredients:2
NDAs:3
Drug Master File Entries: 12

Drugs and US Patents for Alkermes Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes 11,273,158 ⤷  Start Trial ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-004 May 28, 2021 RX Yes No 10,300,054 ⤷  Start Trial Y ⤷  Start Trial
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes Yes 12,251,381 ⤷  Start Trial ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No 11,406,632 ⤷  Start Trial ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-004 May 28, 2021 RX Yes No 8,778,960 ⤷  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 Alkermes Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 8,252,929 ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 7,262,298 ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 8,252,929 ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 7,262,298 ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-004 May 28, 2021 7,956,187 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Alkermes Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 300669 Netherlands ⤷  Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0454436 97C0012 Belgium ⤷  Start Trial PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
1675573 92427 Luxembourg ⤷  Start Trial PRODUCT NAME: ARIPIPRAZOLE
1675573 2014C/029 Belgium ⤷  Start Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
0367141 SPC/GB04/039 United Kingdom ⤷  Start Trial PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Alkermes Inc: Competitive Landscape, Market Position, Strengths, and Strategic Insights

Last updated: April 24, 2026

Where does Alkermes sit in the pharmaceutical competitive landscape?

Alkermes Inc. competes at the intersection of central nervous system (CNS) and injectable/controlled-release drug delivery. Its moat is less about broad therapeutic breadth and more about specialized formulation and commercialization that supports branded CNS products, including long-acting injectables and addiction/behavioral health franchises.

Competitive peer set (most relevant overlap)

Alkermes’ most direct competitive pressure comes from companies that: (1) sell branded CNS therapies, (2) invest in long-acting injectables, and (3) compete on market access and lifecycle management.

Competitive lane Closest peers Why they overlap
Long-acting injectables in CNS Otsuka, Lundbeck, Viatris (legacy Acadia partners depending on asset) Overlap in sustained-release approaches in psychiatry/behavioral health
Branded CNS and payer contracting Janssen, Eli Lilly, Bristol Myers Squibb, Viatris Overlap in CNS formularies and payer negotiations
Substance use disorder and relapse prevention Indivior, Titan Pharmaceuticals (legacy), Independence-type portfolio peers Overlap in treatment pathways for addiction and adherence needs

Alkermes’ competitive profile is defined by scale in its core brands and the execution risk inherent to development-stage pipeline assets and regulatory outcomes, which can shift market share quickly in CNS.

What is Alkermes’ market position by franchise?

Alkermes’ market position is anchored by branded CNS products and its controlled-release delivery platform approach, with revenue exposure tied to a limited set of franchises.

Core competitive reality: concentrated franchise risk

In branded CNS, competition is often “brand-to-brand” with payer steering driven by:

  • formulary placement
  • step therapy and prior authorization criteria
  • manufacturer contracting dynamics
  • differentiating attributes such as dosing frequency and tolerability

Alkermes’ portfolio structure creates both upside and vulnerability: strong performance depends on the durability of specific products and the timing of pipeline transitions.

What are Alkermes’ strengths that translate into competitive advantage?

Alkermes’ strengths cluster around delivery differentiation, regulated product execution, and commercial discipline.

1) Controlled-release and injectable execution

Alkermes has built commercial capability around injectable and long-acting formulations that reduce dosing burden and improve adherence, which is a payer-relevant value driver in chronic CNS conditions.

Where it shows up competitively

  • competing against daily oral CNS regimens on adherence and persistence
  • competing against other long-acting injectables on ease of administration and patient outcomes
  • lifecycle management via label expansions, formulation optimization, and ongoing evidence generation

2) Commercial focus on CNS buyer needs

CNS prescribing is shaped by:

  • symptom severity and comorbidity patterns
  • adherence and discontinuation risk
  • adverse event profiles that affect payer criteria and physician comfort

Alkermes tends to align its go-to-market strategy to those buying levers, which matters in tightly managed formularies.

3) Operational and regulatory execution

CNS injectables require strict manufacturing control and logistics to support:

  • consistent dosing across lots
  • stability and storage requirements
  • distribution reliability

This execution reduces the “implementation risk” that can otherwise create slow adoption even after approval.

4) Pipeline strategy aligned to differentiation

Alkermes’ pipeline investment pattern reflects a preference for assets where it can argue differentiation through:

  • delivery approach
  • duration of effect
  • clinical endpoints that matter to payers and prescribers

Where does Alkermes face the highest competitive pressure?

Competitive pressure for Alkermes tends to show up in four ways: label competition, payer leverage, channel execution, and pipeline timing.

1) Long-acting category crowding

As more competitors pursue long-acting CNS formats, Alkermes faces direct comparisons on:

  • duration
  • tolerability
  • administration workflow
  • evidence breadth in target populations

2) Payer contracting and channel steering

In CNS, payers increasingly influence market outcomes through:

  • preferred brand lists
  • rebate structures
  • step therapy requirements
  • site-of-care or prescriber restrictions

These dynamics can compress gross margins and slow adoption of new entrants even when clinical differentiation exists.

3) Patient adherence economics

Long-acting products compete on total management cost:

  • fewer missed doses
  • reduced relapse or hospitalization risk claims
  • improved persistence

If clinical evidence or real-world adoption lags, payers reduce willingness to maintain premium positioning.

4) Pipeline event risk

CNS drug development has concentrated catalysts. Any adverse trial readout, regulatory delay, or market access challenge can quickly shift competitive standing.

How does Alkermes’ strategy compare to top competitors?

Alkermes competes less like a broad CNS house and more like a specialist in long-acting CNS and behavioral health execution. The strategic differences matter in how each company allocates resources across R&D, commercial, and lifecycle.

Strategic comparison (high-level)

Dimension Alkermes Typical large CNS peers
Portfolio width Narrower, more concentrated franchises Broader multi-asset coverage
Delivery differentiation Strong focus on controlled-release/injectable execution More diversified modalities
Market access muscle Requires precise contracting for premium positioning Stronger leverage via scale and multiple therapeutic classes
Lifecycle approach Evidence-driven franchise extension More aggressive cross-brand formulary dominance
Risk profile Higher sensitivity to individual product transitions Smoother portfolio smoothing

What are the actionable strategic insights for investors and R&D planners?

The competitive landscape implies three immediate implications.

Insight 1: Market share is a function of lifecycle execution, not only approvals

In CNS, sustaining share depends on:

  • label strategy and evidence generation
  • payer re-contracting cadence
  • maintaining administration simplicity and patient persistence
  • preventing “switching pressure” from preferred brands

Action lens: Treat commercial readiness and payer negotiation as core R&D deliverables. Pipeline value depends on launch sequencing and contracting posture.

Insight 2: Delivery differentiation must translate into measurable payer-relevant outcomes

Long-acting benefits can be dismissed if real-world outcomes do not align with claims. Investors should focus on:

  • endpoint selection that links to relapse, symptom control, and discontinuation
  • adoption metrics after launch
  • persistence and adherence signals in post-approval studies

Action lens: Demand evidence plans that support payer contracting narratives early, not after launch.

Insight 3: Pipeline timing determines competitive positioning more than absolute R&D volume

Alkermes’ market position is exposed to “gap risk.” Competitive leadership can erode during periods without clear next-product momentum.

Action lens: Underwrite pipeline not just on probability of success but on:

  • readiness for launch and commercialization
  • likelihood of achieving premium positioning
  • speed to payer acceptance

Competitive “watch list”: where the next inflection is likely to come from

For Alkermes, inflection points typically cluster around:

  • pivotal clinical readouts in CNS behavioral health indications
  • label expansions that extend the treated population
  • launch timing and payer acceptance of new long-acting products
  • competitive entries that reprice the branded long-acting category

Key Takeaways

  • Alkermes’ competitive advantage is specialized: long-acting/controlled-release execution in CNS and behavioral health, not broad therapeutic breadth.
  • Competitive risk is concentrated: market position is sensitive to franchise durability, payer contracting dynamics, and pipeline timing.
  • Market share depends on lifecycle execution: evidence plans, payer posture, and persistence metrics matter as much as regulatory milestones.
  • Next inflection likely tracks pipeline catalysts and payer acceptance: premium positioning requires delivery differentiation to translate into measurable outcomes.

FAQs

  1. What is Alkermes most directly competing against?
    Long-acting and injectable-focused CNS and behavioral health brands that target similar payer and prescriber decision criteria.

  2. What most drives Alkermes’ competitive moat?
    Controlled-release and injectable execution tied to adherence and persistence outcomes that support premium contracting narratives.

  3. How does payer contracting influence Alkermes’ market outcomes?
    Formulary placement and rebate structures can steer prescribing and adoption speed, affecting both revenue and margin durability.

  4. What is the biggest strategic risk for Alkermes?
    Concentration in specific franchises and pipeline timing risk that can create share gaps during transitions.

  5. What should investors monitor to assess competitive strength?
    Post-launch persistence and adoption metrics, payer acceptance velocity, and evidence plans that support premium positioning across product lifecycle.

References

[1] Alkermes Inc. Investor Relations. Form 10-K and annual reports (latest available). Alkermes Inc.

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.