Last Updated: May 10, 2026

Althera Pharms Company Profile


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Summary for Althera Pharms
International Patents:7
US Patents:2
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Althera Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-003 Mar 23, 2021 DISCN Yes No 10,376,470 ⤷  Start Trial Y ⤷  Start Trial
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-001 Mar 23, 2021 DISCN Yes No 10,376,470 ⤷  Start Trial Y ⤷  Start Trial
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-004 Mar 23, 2021 DISCN Yes No 9,763,885 ⤷  Start Trial Y ⤷  Start Trial
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-002 Mar 23, 2021 DISCN Yes No 9,763,885 ⤷  Start Trial Y ⤷  Start Trial
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-003 Mar 23, 2021 DISCN Yes No 9,763,885 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for Althera Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 05C0040 France ⤷  Start Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 03C0028 France ⤷  Start Trial PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
>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.

Althera Pharms Market Analysis and Financial Projection

Last updated: April 24, 2026

Althera Pharms Competitive Landscape Analysis: Market Position, Strengths & Strategic Insights

Althera Pharms holds a narrow competitive footprint focused on opioid dependence treatment through its buprenorphine/naloxone oral film franchise and a build-out in related addiction platforms. The company’s competitive positioning is defined less by breadth of pipeline assets and more by execution in branded-like product performance in a crowded, tightly regulated segment dominated by multi-product incumbents and payer-driven formulary control. The commercial center of gravity is U.S. opioid dependence care, where launch timing, REMS and distribution execution, and payers’ preference for low-cost generics constrain upside.

Where does Althera Pharms sit in the U.S. opioid dependence market?

Althera Pharms competes in opioid use disorder (OUD) maintenance with the standard-of-care active ingredient class: buprenorphine combined with naloxone for office-based treatment. In this category, competitors typically bundle clinical coverage, payer contracting, and multiple strengths or formulations, using scale and rebate leverage to defend share.

Core competitive set (product class and category peers)

  • Reckitt (Suboxone film and related buprenorphine/naloxone formulations)
  • Indivior (Suboxone-related legacy brands and portfolio adjacency across OUD)
  • Sandoz / Teva / Mylan-type generic manufacturers (buprenorphine/naloxone film or equivalent dosage forms, depending on label and exclusivity status)

Althera position (what matters competitively)

  • Product form advantage (oral film): oral film supports adherence and clinician preference versus tablets in some practices; it also competes directly with other film skus where payers allow
  • Access execution: the competitive determinant is not only efficacy and safety, it is payer formulary placement and patient access through pharmacy benefit contracts
  • Line breadth: incumbents generally offer broader sku coverage and can match prescriber switching patterns across dosing needs

What are Althera’s competitive strengths?

Althera’s strengths concentrate around product execution and platform consistency rather than pipeline breadth.

1) Focused commercial strategy in OUD

A focused OUD strategy reduces internal dilution of R&D and commercial operations compared with diversified players. In practice, that increases the company’s ability to manage product lifecycle tasks that heavily impact payers and prescriber habits, including:

  • market access and pharmacy distribution continuity
  • patient support and adherence programs (where required for contracting)
  • proactive handling of product supply risks (critical in a strict regulated chain)

2) Buprenorphine/naloxone differentiation through delivery format

Oral film is a competitive delivery format in OUD care. It reduces barriers for some prescribers and supports adherence in patient populations with swallowing or compliance challenges. It also simplifies switching mechanics for patients already using comparable film dosing.

3) Lower structural overhead than category incumbents

Compared with multinational portfolio players, a smaller company often runs with lower fixed costs and can redirect spend toward market access and pipeline critical-path execution. This matters when payers drive revenue and when large competitors apply price and rebate strategies.


Where are Althera’s competitive vulnerabilities?

Vulnerabilities come from category structure and the way OUD care is monetized.

1) Payer leverage and generic substitution

OUD is a high-formulary-control category. When generic versions are available, payers typically demand lower net pricing or use tiering to shift demand. Brand-like competitive performance can erode quickly unless the company has:

  • favorable rebate position
  • durable contracting terms
  • strong differentiation in plan decision-making

2) Limited product breadth versus multi-sku incumbents

Incumbents and larger generic players tend to cover multiple buprenorphine/naloxone strengths and related dosage forms, which supports prescriber continuity and reduces friction when patients need dose changes.

3) Regulatory and procurement friction in controlled substances logistics

Controlled-substance supply chain performance is non-negotiable. Any disruption in distribution capability, labeling, or dispensing support can affect contracts and refill continuity.


How does Althera’s pipeline shape the competitive outlook?

In OUD, pipeline value is often tied to incremental formulation improvements, extension of product life cycles, or adjacency across addiction medicine. The competitive question is not whether a pipeline exists, but whether it changes payer or prescriber behavior fast enough to offset generic pressure.

Competitive pipeline impact logic

  • If Althera advances new OUD-formulated assets with enforceable exclusivity or differentiation, it can defend commercial relevance
  • If pipeline adds are incremental without differentiated access benefits, they may not materially shift competitive share against incumbents and generics

At present, Althera’s competitive visibility is primarily anchored to its OUD product activity rather than broad multi-mechanism dominance.


Market access and pricing: what drives share in Althera’s category?

OUD products live at the intersection of pharmacy benefit design and prescriber practice patterns. Competitive outcomes are driven by:

Formulary placement

Plans evaluate:

  • net price after rebates
  • step therapy constraints
  • therapeutic interchange rules
  • pharmacy channel considerations

Drug utilization management

Common mechanisms include:

  • tiering to steer toward preferred products
  • quantity limits or prior authorization, depending on plan design
  • incentive structures within PBM networks

Contracting discipline

Smaller companies win or lose on execution:

  • rebate negotiation cadence
  • compliance and documentation quality
  • supply reliability that prevents plan-level disruptions

What do incumbents and generics do to defend against entrants like Althera?

Category defense strategies tend to be repeatable.

Incumbents

  • cross-sku coverage across dosing needs to reduce switching
  • payer contracting scale and rebate leverage
  • clinician familiarity and established patient support infrastructure

Generics

  • aggressive pricing
  • broad distribution availability
  • plan preference via lowest net cost policies

This puts pressure on Althera to maintain distinct access advantages beyond clinical equivalence.


Competitive positioning by “decision lever”: summary matrix

Decision lever What the market optimizes Where Althera is likely strongest Where Althera is likely weakest
Payer formulary Lowest net cost and manageable contracting Execution focus in OUD access Generic substitution threat and rebate pressure
Prescriber adoption Familiarity, workflow fit, dosing continuity Oral film delivery advantage in relevant settings Multi-sku breadth disadvantage vs incumbents
Patient adherence Ease of use and consistent refills Product form support Controlled-substance logistics and switching friction
Pipeline impact Practical differentiation that changes access Focused OUD platform consistency Limited ability to offset generic dynamics fast

Strategic insights: how Althera should compete next

1) Compete on access mechanics, not only on product form

Given payer power and generic substitution, the strategic center should be net pricing and contract defensibility. That means:

  • prioritize PBM and plan contracting routes that preserve share at net terms
  • target formulary segments where oral film delivery format is favored or where formulary constraints keep alternatives limited

2) Reduce churn risk by improving continuity of supply and SKU availability

OUD care requires stable refills. Operational excellence in supply continuity and dosing coverage reduces plan friction and prescriber switching.

3) Use pipeline additions to strengthen lifecycle rather than chase breadth

In this category, each added asset must either:

  • extend enforceable competitive duration, or
  • create access-based differentiation (coverage, switching barriers, or contracting advantages)

Without that, pipeline adds risk becoming cost centers.


Key Takeaways

  • Althera’s market position is concentrated in OUD treatment, where competitive outcomes hinge on payer contracting and access execution more than on broad pipeline breadth.
  • Its primary competitive strengths are delivery-format fit (oral film) and disciplined focus in a controlled, regulated segment.
  • The company’s biggest structural risk is generic substitution and payer-driven low net price selection, amplified by larger competitors’ multi-sku coverage and contracting scale.
  • The fastest path to defensive share is to win formulary mechanics and reduce churn via supply continuity and dosing continuity.

FAQs

How does payer formulary design affect Althera’s sales potential?

Plans prioritize net cost and utilization controls. Even clinically equivalent products can lose share quickly when PBMs tier aggressively or mandate step therapy.

What is Althera’s main competitive differentiator in OUD care?

Its competitive differentiator is the oral film delivery format within the buprenorphine/naloxone class, paired with execution that supports payer and prescriber workflows.

Who are Althera’s most direct rivals?

Direct category rivals include major buprenorphine/naloxone incumbents and generic manufacturers competing for formulary placement and prescribing share in OUD.

Why does SKU breadth matter so much in buprenorphine/naloxone?

Patients often need dose adjustments. Multi-sku coverage reduces prescriber friction and supports continuity, which strengthens incumbent contracting leverage.

What should drive Althera’s next strategic investments?

Investments should prioritize market access contracting capabilities and lifecycle protection actions (supply reliability, stable dosing availability, and pipeline additions that change access economics).


References

[1] U.S. Food and Drug Administration. Drug Approval Reports and Label Information for buprenorphine/naloxone products. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. Medication Guides and REMS-related information for opioid use disorder treatments (buprenorphine-based products). https://www.fda.gov/
[3] National Academies / consensus reporting on OUD medication standards and clinical practice context for buprenorphine-based therapy (background material). https://www.nationalacademies.org/

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