Last Updated: August 9, 2026

ATORVALIQ Drug Patent Profile


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

Atorvaliq is a drug marketed by Cmp Dev Llc and is included in one NDA. There are six patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ATORVALIQ is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Atorvaliq

A generic version of ATORVALIQ was approved as atorvastatin calcium by APOTEX INC on May 29th, 2012.

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Questions you can ask:
  • What is the 5 year forecast for ATORVALIQ?
  • What are the global sales for ATORVALIQ?
  • What is Average Wholesale Price for ATORVALIQ?
Summary for ATORVALIQ
International Patents:2
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 31
Patent Applications: 1,027
Drug Prices: Drug price information for ATORVALIQ
What excipients (inactive ingredients) are in ATORVALIQ?ATORVALIQ excipients list
DailyMed Link:ATORVALIQ at DailyMed
Pharmacology for ATORVALIQ

US Patents and Regulatory Information for ATORVALIQ

ATORVALIQ is protected by seven US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cmp Dev Llc ATORVALIQ atorvastatin calcium SUSPENSION;ORAL 213260-001 Feb 1, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Cmp Dev Llc ATORVALIQ atorvastatin calcium SUSPENSION;ORAL 213260-001 Feb 1, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Cmp Dev Llc ATORVALIQ atorvastatin calcium SUSPENSION;ORAL 213260-001 Feb 1, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Cmp Dev Llc ATORVALIQ atorvastatin calcium SUSPENSION;ORAL 213260-001 Feb 1, 2023 RX Yes Yes ⤷  Start Trial ⤷  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

International Patents for ATORVALIQ

See the table below for patents covering ATORVALIQ around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3468606 NOUVELLE COMPOSITION PHARMACEUTIQUE DE COMPOSÉ HYPOLIPIDÉMIANT (A NOVEL PHARMACEUTICAL COMPOSITION OF A LIPID LOWERING COMPOUND) ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2017212409 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2017212409 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ATORVALIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0247633 C970034 Netherlands ⤷  Start Trial PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
0247633 97C0118 France ⤷  Start Trial PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
0247633 97C0103 Belgium ⤷  Start Trial PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
0247633 62/1997 Austria ⤷  Start Trial PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

ATORVALIQ (atorvastatin) Market Dynamics and Financial Trajectory: Revenue Mix, Competition, Patent/Exclusivity Timing, and Generic Risk

Last updated: July 29, 2026

AtorvaLiq is an atorvastatin product. Its market trajectory is driven by (1) ongoing erosion from authorized generics and interchangeable brands, (2) pricing resets tied to payer formularies and volume-based contracting, and (3) speed and scope of generic entry once regulatory and patent barriers clear. Financial performance is typically dominated by wholesale buy-sell economics, rebate intensity, and mix shift across dose strengths and package formats, with high sensitivity to national formulary placement and pharmacy network reimbursement rates.

The analysis below maps the commercial drivers and competitive dynamics that determine AtorvaLiq sales, but it does not include quantified revenue forecasts or exact unit and dollar figures because source-specific financial and regulatory records for “ATORVALIQ” are not provided here.

What is ATORVALIQ and how does its atorvastatin positioning affect market demand?

Featured snippet: AtorvaLiq is an atorvastatin-based lipid-lowering therapy. Demand tracks cardiovascular risk screening, adherence to statin therapy, and payer coverage rules, with most growth coming from switching and formulation mix rather than new prescriptions.

Therapeutic category and payer behavior

Atorvastatin sits in the HMG-CoA reductase inhibitor class used for:

  • Primary hypercholesterolemia and mixed dyslipidemia
  • Secondary prevention after cardiovascular events
  • Risk reduction in specific guideline populations

Commercially, statins behave like “high-penetration chronic maintenance” drugs:

  • Most patients eligible are already on treatment; incremental growth depends on new diagnosis/uptake and persistence improvements.
  • Payers heavily negotiate pricing through rebates and formulary tier placement because clinical differentiation is limited at the molecule level.
  • Switching between statins is common when a payer changes its preferred agent.

Dose-strength and formulation mix

For atorvastatin products, revenue is typically sensitive to:

  • Dose mix (10 mg, 20 mg, 40 mg, 80 mg)
  • Package size (30-count vs 90-count supply economics)
  • Pharmacy channel mix (retail vs mail order)
  • Therapeutic interchange rules that allow substitution at the pharmacy counter

AtorvaLiq performance is therefore less about “net new users” and more about maintaining formulary status and preserving contracted net price.


How do pricing, rebates, and formulary placement determine ATORVALIQ net revenue?

Featured snippet: Statin net revenue is shaped by net price after rebates and contracting. If AtorvaLiq is on preferred tiers, it retains share. If it slips to non-preferred or faces step edits, volume declines quickly.

Net price mechanics

In the US and other mature markets, atorvastatin brands and branded generics face:

  • Mandatory rebate structures tied to quarterly formulary reviews
  • Contracting that links net price to market share or pharmacy channel targets
  • Increased pressure when additional generics enter, raising buyer leverage

What “market dynamics” means for this category

  • Wholesale acquisition price (WAC) drift: can continue even as net price declines, until payers impose new contracted rates.
  • PBM formulary dynamics: a single formulary change can trigger measurable volume shifts in subsequent dispensing cycles.
  • Exclusivity erosion: once multiple low-cost options exist, the main lever becomes retention through payer-specific value arguments (supply, packaging, patient support) rather than clinical differentiation.

When does generic substitution accelerate for ATORVALIQ and what triggers it?

Featured snippet: Generic substitution accelerates when interchangeability and broad generic availability converge, usually around exclusivity or patent-expiration windows, followed by post-launch competitive pricing.

Regulatory and competitive trigger points

Three events typically cause step-function changes in category pricing:

  1. Initial generic entry: launches with higher launch pricing than later entrants.
  2. Multi-generic saturation: multiple players compress net price further and raise rebate pressure.
  3. Interchangeability and formulary hardening: PBMs and plans standardize on the lowest-cost equivalent products in their preferred tier.

Timing framework

Because “ATORVALIQ” can refer to different commercial presentations in different jurisdictions, the exact dates that govern substitution risk cannot be stated without the product’s specific FDA approval, NDC list, and Orange Book mapping. The practical market implication is consistent: once the regulatory/patent gates are opened, the statin category typically experiences rapid margin compression across all non-lowest-cost SKUs.


What patents protect ATORVALIQ (atorvastatin) and how strong is the patent estate?

Featured snippet: For atorvastatin products, the patent estate that matters commercially usually clusters around specific formulations, manufacturing/process steps, and method-of-use or brand-specific presentation claims. Base atorvastatin molecule claims are long expired in most jurisdictions.

How patent strength affects commercialization economics

For a statin brand or branded product, patent strength is commercially relevant only if it:

  • Prevents generic approval (Paragraph IV and settlement outcomes)
  • Restricts “skinny labeling” or equivalent composition approvals (rare for molecule-level statins)
  • Protects a specific formulation (limited effect if interchange is allowed)

Litigation and settlements as pricing catalysts

When patent challenges lead to:

  • A delayed generic launch (exclusionary settlement)
  • A license that permits earlier, but at royalty-linked pricing
  • A partial launch with limited strengths
    …net price often improves temporarily. Without product-specific litigation, this pathway cannot be mapped precisely for AtorvaLiq.

What is the Orange Book status of ATORVALIQ and what does that imply for generic entry?

Featured snippet: Orange Book status determines whether generic entrants face listed patents at the time of application. A lean listing typically correlates with faster generic competition; a dense listing increases the likelihood of litigation or delayed launch.

What to look for on the Orange Book (commercially)

  • Listed patents by claim type (drug substance, drug product, method of use)
  • Expiration dates and whether patents are effectively “at-risk” via challenges
  • NDA/NDC coverage breadth across dose strengths

This article cannot provide the Orange Book listing for “ATORVALIQ” because the underlying NDA/NDC identifiers are not supplied.


Which companies are the main competitive threats to ATORVALIQ?

Featured snippet: The competitive set for atorvastatin is dominated by authorized generics, multi-source generics, and large players with scale rebate and supply-chain advantages.

Typical competitive categories

  • Large generic manufacturers with multi-NDC portfolios and fast market coverage
  • Authorized generics that often launch quickly and secure volume through contracting
  • Retail-mix and mail-order-mix shifts that benefit manufacturers with stronger distribution leverage

AtorvaLiq’s share retention depends on whether it is positioned as a preferred contracted option or is forced into the non-preferred tier as generics proliferate.


How does ATORVALIQ compare with other atorvastatin brands and branded generics on market share and pricing?

Featured snippet: Atorvastatin competitors generally converge on similar net prices. The differentiators are contract terms, distribution reliability, and packaging.

Competitive axes

  1. Net price and rebate intensity
  2. Formulary tier placement
  3. Dose coverage breadth
  4. Switching friction (prior authorization, step therapy, quantity limits)

In mature statin markets, the “best competitor” is usually not a branded clinical alternative but the lowest-net-cost equivalent that a payer chooses as preferred.


What generic entry risks exist for ATORVALIQ, including Paragraph IV challenges?

Featured snippet: Generic entry risk is driven by (1) whether any listed patents are still in force, (2) whether they are plausibly challengeable, and (3) how quickly challengers can obtain approval and launch across strengths.

Paragraph IV risk profile

For statin products, the molecule-level freedom to operate typically exists, so remaining risks usually relate to:

  • Product-specific patents (formulation and manufacturing)
  • Brand-specific presentation claims

Absent the patent list for AtorvaLiq, the Paragraph IV risk cannot be assigned to specific claims or expirations.


What FDA milestones and switching rules affect ATORVALIQ commercialization?

Featured snippet: FDA milestones matter less than substitution and interchange rules, unless AtorvaLiq is tied to a distinct formulation route with limited interchangeability.

Commercially relevant FDA factors

  • Approval pathway type (innovator, branded generic, or reformulation)
  • Pharmacokinetic and labeling constraints that can limit interchange
  • Patented conditions of use that create labeling barriers for generics

Without the product’s FDA application identifiers, the milestone mapping cannot be completed.


What manufacturing and supply-chain dynamics influence ATORVALIQ financial trajectory?

Featured snippet: For genericized chronic products like statins, supply reliability is a major determinant of share during competitive launches.

Key supply-chain drivers

  • API sourcing stability and contract manufacturing capacity
  • Packaging line availability (90-day supplies often carry different reimbursement economics)
  • Batch release and quality system performance during ramp periods

When generics enter, supply disruptions can create temporary share gains for the intact supplier, but the category quickly normalizes once competing inventory clears.


How should investors and licensors underwrite ATORVALIQ revenue under competitive pressure?

Featured snippet: Underwrite net revenue sensitivity to rebate rate and formulary placement more than to baseline demand growth.

Underwriting model structure (category standard)

  • Volume = scripts × persistence × share on preferred tier
  • Net price = contracted net price after rebates and fees
  • Margin = gross margin after pass-through manufacturing costs and chargebacks

Even modest shifts in preferred placement can outweigh longer-horizon category growth. For atorvastatin, that makes payer channel strategy the most important investment variable.


What are the most likely financial trajectory scenarios for ATORVALIQ?

Featured snippet: Expect a “plateau then compression” trajectory unless AtorvaLiq holds a durable differentiation via formulation or strong payer lock-in.

Scenario framework

  1. Preferred-tier retention scenario
    • Net price stays relatively stable
    • Volume holds or slowly declines with category maturity
  2. Tier slippage scenario
    • Volume declines as prescriptions shift to preferred equivalents
    • Net price resets downward due to harder contracting
  3. Post-generic saturation scenario
    • Multiple-equivalent lowest-cost options drive rapid net price compression
    • Revenue shifts to whichever strengths and pack sizes preserve the best rebate economics

This framework is standard for statins, but product-specific inputs are required for exact forecast numbers.


Key Takeaways

  • AtorvaLiq’s commercial performance in the atorvastatin category is governed by net price after rebates, formulary tier status, and channel contracting rather than by clinical differentiation.
  • Competitive risk typically accelerates after generic entry and multi-source saturation, producing margin compression across brands and branded generics.
  • Patent and Orange Book status determine whether entry is delayed or managed via litigation and settlements, but those records for “ATORVALIQ” are not provided here, so no claim-level or date-level conclusions can be stated.
  • The most material financial variables to track are preferred formulary placement, rebate rate changes, and share across dose strengths and package sizes.

FAQs

  1. What net price compression rates typically occur for atorvastatin after multi-generic entry?
  2. How do PBM formulary changes impact statin brand share within 1 to 2 quarters?
  3. Do formulation patents meaningfully delay generics for atorvastatin products?
  4. What contracting levers help a statin brand remain preferred when authorized generics launch?
  5. How do 90-day supply programs and mail order policies change statin revenue mix?

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
  2. FDA. Drug Approval and Databases. U.S. Food and Drug Administration.

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