Last Updated: May 3, 2026

Alkermes Company Profile


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Drugs and US Patents for Alkermes

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 10,300,054 ⤷  Start Trial Y ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No 8,431,576 ⤷  Start Trial Y ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 10,716,785 ⤷  Start Trial ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No 12,251,381 ⤷  Start Trial ⤷  Start Trial
Alkermes Gainesville KETOPROFEN ketoprofen CAPSULE, EXTENDED RELEASE;ORAL 074879-001 Dec 10, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes 10,226,458 ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,534,092 ⤷  Start Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,264,987 ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 8,252,929 ⤷  Start Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,596,316 ⤷  Start Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,110,503 ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 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 Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2316456 132017000142109 Italy ⤷  Start Trial PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 2017/059 Ireland ⤷  Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
1675573 C300669 Netherlands ⤷  Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 300669 Netherlands ⤷  Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Alkermes: Pharmaceutical Competitive Landscape Analysis, Market Position, Strengths & Strategic Insights

Last updated: April 23, 2026

Where does Alkermes sit in the pharma competitive landscape?

Alkermes, Inc. is positioned as a specialty pharmaceutical company with a dominant platform-based identity in long-acting injectables and central nervous system (CNS) therapeutics. Its competitive set is best understood along two axes: (1) branded CNS franchise dynamics and (2) long-acting depot and delivery-system competition that targets high-value commercial outcomes in schizophrenia, bipolar disorder, and substance use disorder (SUD).

Core competitive attributes:

  • Long-acting, injectable CNS products with recurring dosing benefits and label-driven switching dynamics.
  • Platform differentiation centered on extended-release formulations and depots.
  • Managed commercialization focus on high-value segments where contracting and payor design can determine share retention.

Where it competes most directly:

  • CNS long-acting injectables against companies with depot portfolios (notably Janssen, Otsuka, and Viatris via legacy and partner assets depending on product lineage).
  • SUD and opioid-use disorder (OUD) segments where long-acting options, adherence outcomes, and payer economics shape access.
  • Specialty payer contracting against manufacturers that can defend net price through patient support and outcomes-aligned messaging.

What is Alkermes’ market position by franchise and product dependence?

Alkermes’ commercial exposure is concentrated in CNS and addiction-related franchises, with depot-like structures that tend to be harder for generics to displace quickly because of formulation complexity, clinical equivalence requirements, and prescriber comfort.

Market position indicators (company-level structure):

  • Specialty concentration: Alkermes has historically relied on a small number of core products rather than a broad primary-care portfolio.
  • Therapy clustering: products cluster in CNS and SUD, where long-term adherence and reduced relapse risk are key drivers of payer and clinician behavior.
  • Execution model: the company’s strategy has leaned on product lifecycle management, dosing convenience, and patient support.

What are Alkermes’ key strengths that competitors try to replicate?

Alkermes’ competitive strengths cluster into product design and go-to-market capabilities that directly impact payer and prescriber adoption.

1) Long-acting CNS delivery and adherence economics

Long-acting injectables create a structural advantage in populations where adherence drives clinical outcomes. This shifts competition from “drug to drug” to “regimen to regimen,” with payors evaluating total-treatment costs, relapse-related costs, and continuity-of-care.

Why it matters competitively:

  • Depot dosing reduces missed doses, which can reduce relapse-driven downstream utilization.
  • Clinicians who switch patients to a depot regimen weigh tolerability profiles and injection burden against relapse history.

2) Depth in CNS commercial execution

Alkermes’ CNS focus aligns with:

  • Specialty prescriber relationships
  • Care pathway integration with mental health systems
  • Ongoing support for injection workflows

3) Platform repeatability

Alkermes’ delivery-system identity is designed to support multiple product generations. Competitors can match specific molecules, but they typically face higher barriers when trying to replicate proprietary depot behaviors and clinical expectations across a class.

Where are the competitive vulnerabilities for Alkermes?

Competitive risk for Alkermes clusters in five areas common to specialty CNS and depot portfolios.

1) Label boundaries and comparative positioning

In CNS, small differences in efficacy endpoints or tolerability can decide formulary inclusion. Competitors with superior head-to-head data or more favorable safety signals can pressure access, particularly in Medicare Advantage and Medicaid expansions.

2) Payer leverage and contracting pressure

High-cost injectable therapies are increasingly managed through:

  • Preferred tier placement
  • Prior authorization protocols
  • Step therapy for certain switching populations

3) Competitive entry timing

When competitor depots or next-generation formulations enter, uptake can be fast if:

  • Administration pathways are already established in the health system
  • Net price and rebates are competitive
  • Prior authorization criteria are harmonized

4) Manufacturing and supply continuity

For injectables, continuity of supply is a core competitive requirement. Any disruption in supply, lead times, or distribution reliability can cause preference loss that is hard to recover.

5) Franchise concentration

A small set of products can drive revenue volatility. When payer restrictions or competitor switches hit one franchise, overall performance can be disproportionate versus diversified specialty peers.

Who are Alkermes’ relevant competitors and how do they differ?

Alkermes’ competitive landscape is primarily shaped by companies that either (a) lead in depot CNS portfolios, or (b) have scale and contracting leverage.

Direct competition: long-acting CNS and SUD portfolios

  • Janssen (J&J): depot-like schizophrenia and related CNS portfolios and broad access footprint.
  • Otsuka: strong standing in schizophrenia and related CNS markets with established long-acting presence.
  • Viatris (historical/portfolio-dependent overlap): some market overlap depending on product line evolution and partner structures.

Indirect competition: specialty pharma with CNS assets and payer leverage

  • Large-cap specialty franchises with contracting scale and multi-product payer relationships can outmaneuver depot-focused firms on access and formulary design.

Competitive differentiators that matter most in formulary decisions:

  • Net price and rebate economics
  • Clinical differentiation tied to endpoints payors monitor
  • Administration workflow fit (site of care, injection schedule integration)
  • Demonstrated persistence and discontinuation rates

How do regulatory and reimbursement dynamics shape the competitive fight?

CNS long-acting injectables are highly exposed to reimbursement rules and coverage criteria.

Coverage and access forces

  • Prior authorization: typically requires documentation of diagnosis, prior treatment history, or step criteria.
  • Formulary tiering: preferred access drives share; non-preferred status slows uptake.
  • Patient support programs: can reduce real-world barriers to initiation, particularly when payor coverage delays exist.

Clinical evidence standards

For switching and initial uptake, clinicians prioritize:

  • Demonstrated tolerability in the target population
  • Label-consistent efficacy
  • Injection site and overall treatment tolerability

What strategic moves can Alkermes use to defend share and expand?

The most effective strategy for a depot-focused CNS player is not broad portfolio expansion; it is targeted defense and selective growth in dosing-adherent care pathways.

1) Defense via contracting precision

  • Align net pricing and rebates with payor-specific formulary thresholds.
  • Build coverage dossiers that emphasize reduced discontinuation and adherence stability.

2) Franchise lifecycle management

  • Optimize label utilization through prescriber education on eligible populations.
  • Tighten injection workflow support to improve persistence and reduce missed-dose risk.

3) Maximize sequencing advantages

  • Where clinical pathways allow, position depot use as an early continuity strategy rather than a late-line option.
  • Use initiation and re-initiation programs to reduce attrition after interruptions.

4) Expand beyond primary indications using label-consistent evidence

In CNS and SUD, expansion depends on label eligibility and credible clinical outcomes. Alkermes’ delivery platform can support incremental lifecycle growth if evidence supports dosing and patient outcomes.

How does Alkermes’ “platform identity” translate into competitive edge?

Depot formulation platforms can matter if they deliver repeatable outcomes:

  • Consistent release profiles that match clinical expectations
  • Patient acceptability that supports persistence
  • Manufacturability that supports stable supply commitments

Competitors can develop alternative molecules, but depot parity requires:

  • Formulation development that meets clinical equivalence expectations
  • Clinical and regulatory programs that reduce uncertainty for prescribers

What are the investment-relevant implications for Alkermes’ competitive position?

For business and investment decisions, Alkermes’ competitive profile implies:

  • Value is tied to persistence and access. Depot franchises rise or fall on continuity.
  • Net price volatility can dominate unit growth. Access wins may not translate if rebates and contracting shift unfavorably.
  • Pipeline optionality is delivery-platform dependent. Platform success can extend the franchise rather than create entirely new revenue engines.

In practical terms, Alkermes should be evaluated on:

  • Share stability in key depot indications
  • Contracting outcomes (preferred tier placement and PA efficiency)
  • Supply continuity and manufacturing performance
  • Evidence of persistence (discontinuation rates and switch rates)

Key Takeaways

  • Alkermes competes primarily in CNS and SUD long-acting injectables, where adherence, payer access, and injection workflow fit drive share more than molecule-only differentiation.
  • Its strengths are rooted in long-acting delivery capabilities and CNS-focused commercialization, which supports persistence and reduces missed dosing barriers.
  • Competitive vulnerabilities include label-boundary sensitivity, payer contracting pressure, timing risks around newer depot entries, and revenue concentration.
  • The most defensible strategy is contracting precision plus franchise lifecycle execution that sustains persistence and defends preferred access, paired with continued platform-driven product extensions.
  • Investment-relevant assessment should prioritize access, persistence, net price dynamics, and supply continuity, not only headline clinical positioning.

FAQs

  1. What drives competitive share in Alkermes’ main market segments?
    Access and persistence in long-acting CNS/SUD regimens, shaped by payer contracting, prior authorization, and prescriber comfort.

  2. Which competitor types pressure Alkermes most?
    Companies with established depot CNS portfolios and strong payer contracting scale, which can displace via formulary preference and net price economics.

  3. How does payer management affect depot injectable manufacturers like Alkermes?
    Prior authorization and formulary tiering can reduce uptake speed, and rebate structures can determine whether share gains translate into durable revenue.

  4. What operational factor matters most for long-acting injectables?
    Supply continuity and injection workflow reliability, because disruptions can permanently change prescriber and patient preferences.

  5. What is the strategic role of Alkermes’ delivery platform?
    It helps create repeatable long-acting depot products where clinical expectations, persistence, and manufacturability are tied to competitive positioning.


References

[1] Alkermes, Inc. (2025). SEC filings and investor materials (10-K/10-Q/press releases). U.S. Securities and Exchange Commission.
[2] U.S. Food and Drug Administration. (2025). Drug approvals and labeling (access to prescribing information databases). FDA.
[3] Centers for Medicare & Medicaid Services. (2025). Coverage and reimbursement policy frameworks (Medicare Part D and coverage determinations overview). CMS.

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