ASPIRIN; PRAVASTATIN SODIUM - Generic Drug Details

What are the generic drug sources for aspirin; pravastatin sodium and what is the scope of patent protection?

Aspirin; pravastatin sodium is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ASPIRIN; PRAVASTATIN SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	ASPIRIN; PRAVASTATIN SODIUM at DailyMed

Recent Clinical Trials for ASPIRIN; PRAVASTATIN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Pennsylvania	Phase 4
Kos Pharmaceuticals	Phase 4
The Dana Foundation	Phase 4

See all ASPIRIN; PRAVASTATIN SODIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ASPIRIN; PRAVASTATIN SODIUM

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for ASPIRIN; PRAVASTATIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-002	Jun 24, 2003		DISCN	No	No
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-004	Jun 24, 2003		DISCN	No	No
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-003	Jun 24, 2003		DISCN	No	No

Aspirin and Pravastatin Sodium Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 5, 2026

Aspirin and pravastatin sodium are mature, off-patent cardiovascular medicines with sharply different market structures. Aspirin is an ultra-low-cost, high-volume active ingredient sold mainly through over-the-counter products, including Bayer-branded formulations and private-label products. Pravastatin sodium is a prescription generic statin whose commercial decline reflects therapeutic substitution by atorvastatin and rosuvastatin, lower generic prices, and limited differentiation.

Neither product has meaningful remaining U.S. regulatory exclusivity. Aspirin has no biosimilar or conventional generic-entry event because it is a small-molecule ingredient with a century-old market history. Pravastatin has been exposed to generic competition since the mid-2000s, and its historical compound and formulation patents no longer provide a material barrier to entry.

What is the current market position of aspirin?

Aspirin is a mature, globally commoditized small-molecule drug used for analgesia, fever reduction, inflammation, antiplatelet therapy, and secondary prevention of cardiovascular events. Its commercial market is divided between:

Segment	Primary use	Market structure
OTC analgesic aspirin	Pain and fever	Brand, private-label, and store-brand competition
Low-dose aspirin	Antiplatelet therapy	Predominantly generic and private-label
Prescription aspirin combinations	Cardiovascular and procedural use	Institutional and specialty distribution
Hospital aspirin	Acute cardiovascular care	Low unit cost, procurement-driven

Bayer retains strong consumer recognition for aspirin, but the active ingredient itself is not proprietary. Retailers, generic manufacturers, contract manufacturers, and regional brands compete primarily on price, packaging, distribution, and dosage form.

The U.S. Preventive Services Task Force has narrowed the role of aspirin in primary prevention because bleeding risk can outweigh cardiovascular benefit in some patients. That policy shift limits growth in preventive use, even though aspirin remains established in secondary prevention and acute coronary syndrome treatment (U.S. Preventive Services Task Force, 2022).

When did aspirin lose patent exclusivity?

Aspirin lost meaningful patent exclusivity more than a century ago. The compound was introduced commercially in the late 19th century, and no modern U.S. patent estate protects acetylsalicylic acid as an active pharmaceutical ingredient.

Current protection can exist around particular commercial features, including:

• Enteric-coated tablets
• Effervescent formulations
• Combination products
• Unit-dose packaging
• Child-resistant containers
• Manufacturing processes
• Brand trademarks and trade dress

These rights do not recreate active-ingredient exclusivity. They may support product differentiation but generally do not prevent generic or private-label aspirin sales.

What patent litigation affects aspirin?

There is no central, active patent dispute over aspirin’s basic composition. Litigation risk is usually product-specific and may involve:

• Packaging or labeling claims
• Combination products
• Modified-release dosage forms
• Trade dress
• Manufacturing contracts
• Advertising claims

Aspirin is not listed in the Orange Book as a modern branded drug with a commercially significant patent estate. FDA approval status depends on the applicable OTC monograph framework, approved prescription products, or abbreviated applications for specific formulations.

What is the patent status of pravastatin sodium?

Pravastatin sodium is the sodium salt of pravastatin, an HMG-CoA reductase inhibitor originally commercialized by Bristol-Myers Squibb as Pravachol. The product received U.S. FDA approval in 1991 (U.S. Food and Drug Administration [FDA], 1991).

The principal U.S. compound patent historically associated with pravastatin is U.S. Patent No. 4,346,227. Its effective protection ended in the mid-2000s after applicable patent-term adjustments or extensions. Generic pravastatin sodium products entered the U.S. market in 2006 after the principal exclusivity period ended.

Patent or regulatory asset	Product	Historical status
U.S. Patent No. 4,346,227	Pravastatin and related compounds	Expired; no current compound barrier
Pravachol FDA approval	Pravastatin sodium tablets	Approved in 1991
U.S. pediatric exclusivity	Pravachol	Historical exclusivity, expired
Orange Book product patents	Pravachol	No material current barrier to generic entry

The relevant patent estate is therefore historical rather than commercially active. Current generic competition is not dependent on a successful Paragraph IV challenge to a live compound patent.

How many patents cover pravastatin sodium today?

No material unexpired U.S. patent appears to protect pravastatin sodium as a standalone active ingredient. Historical patent coverage included the compound, pharmaceutical compositions, and manufacturing-related subject matter. Any surviving patent claims would need to be assessed individually by jurisdiction, claim scope, and enforceability, but they do not create a broad commercial barrier comparable to a live composition-of-matter patent.

Formulation patents are also weak as a market-control mechanism because pravastatin is available in conventional immediate-release tablet products. A manufacturer would generally be able to design around narrow claims involving excipients, coating systems, or specific manufacturing parameters.

What formulations are protected by pravastatin patents?

The commercially important product is an oral tablet containing pravastatin sodium. Historical protection and regulatory filings covered conventional tablet formulations and manufacturing processes. Current market access does not depend on preserving a proprietary delivery system.

Potential formulation differentiation includes:

• Tablet strength
• Film coating
• Excipients
• Packaging
• Fixed-dose combinations
• Alternate dosage forms

These attributes may support a product application or a niche commercial position, but they are unlikely to support durable price premiums without clinical or distribution advantages.

What is the Orange Book status of aspirin and pravastatin?

Aspirin and pravastatin have different regulatory profiles.

Aspirin

Aspirin products may be marketed under OTC monograph requirements, prescription approvals, or approved abbreviated applications depending on the dosage form and indication. The active ingredient is long established and does not carry modern new-drug exclusivity.

Pravastatin sodium

Pravastatin sodium tablets are generic prescription products. Historical Pravachol patents and exclusivities have expired. Current abbreviated new drug applications are therefore generally based on bioequivalence to the reference product, subject to FDA requirements for the relevant strength and dosage form.

There is no meaningful current new chemical entity exclusivity, orphan exclusivity, or pediatric exclusivity for either product.

Regulatory category	Aspirin	Pravastatin sodium
New chemical entity exclusivity	None	Expired
Active patent protection	None of commercial significance	Expired
Paragraph IV exposure	Not commercially relevant for core aspirin	Historical and largely exhausted
Biosimilar exposure	Not applicable	Not applicable
Current FDA exclusivity leverage	Minimal	Minimal

Which companies are challenging pravastatin’s market?

Pravastatin is already a generic market rather than a branded product facing a new wave of challengers. U.S. suppliers have included major generic manufacturers and authorized distributors such as Teva, Sandoz, Dr. Reddy’s Laboratories, Lupin, Glenmark, Mylan, and other FDA-approved suppliers, subject to changes in product ownership and market participation over time.

The competitive issue is not whether a generic can enter. It is whether a supplier can maintain profitable supply at a sufficiently large scale.

Generic statin competition is structurally intense because:

1. Pravastatin has no meaningful patent barrier.
2. Several alternative statins offer stronger low-density lipoprotein reduction.
3. Pharmacy benefit managers favor low-cost products.
4. Retail pharmacies can substitute among approved generic suppliers.
5. Hospitals and wholesalers purchase on price and supply reliability.

How does pravastatin compare with atorvastatin and rosuvastatin?

Pravastatin occupies a lower-intensity position within the statin class.

Attribute	Pravastatin sodium	Atorvastatin calcium	Rosuvastatin calcium
Potency	Moderate to low	High	High
Generic availability	Long established	Long established	Long established
Typical commercial role	Older-patient and tolerability-oriented use	Broad first-line use	High-potency LDL reduction
Patent status	Expired	Expired	Expired or largely exhausted by market
Price structure	Low generic price	Low generic price	Low generic price
Growth outlook	Flat to declining	Volume-driven mature	More resilient, but mature

Pravastatin may retain use where clinicians prioritize a lower-interaction profile or where patients tolerate it better than other statins. Its lower potency limits its role when guidelines call for substantial LDL reduction.

Aspirin has a broader consumer footprint than pravastatin, but its revenue per unit is far lower and its market is more exposed to private-label substitution. Pravastatin has a narrower patient population but a prescription-based reimbursement channel.

What is the financial trajectory for aspirin?

Aspirin revenue is mature and fragmented. Product-specific sales are difficult to isolate because major manufacturers report aspirin within broader consumer-health categories. Bayer reports Consumer Health performance at a portfolio level rather than providing a separate global aspirin revenue line in its principal financial reporting (Bayer AG, 2023).

The financial profile has four defining characteristics:

• High unit volume
• Low average selling price
• Strong private-label pressure
• Stable but limited long-term growth

Revenue can rise through price increases, premium packaging, combination products, and distribution expansion. Volume growth is constrained by the maturity of the category and changing medical guidance for primary prevention.

Margin performance depends on input costs, packaging, retailer bargaining power, manufacturing scale, and product mix. Branded aspirin can earn higher gross margins than store-brand aspirin, but trademark strength does not prevent ingredient-level substitution.

What is the financial trajectory for pravastatin sodium?

Pravastatin’s financial trajectory is a classic post-exclusivity decline. Branded Pravachol generated significant sales during the protected period, but revenue fell after generic entry. Later growth has been volume-based and limited by low pricing.

A simplified lifecycle is:

Period	Commercial phase	Financial effect
1991 to early 2000s	Branded exclusivity	High pricing and strong product contribution
Mid-2000s	Generic entry	Rapid price erosion and branded revenue decline
2010s	Mature generic market	Low prices, fragmented supply
2020s	Late mature market	Stable demand with limited pricing power

Current product-level revenue is not reliably disclosed by most generic suppliers. Generic manufacturers usually report total portfolio revenue, making pravastatin-specific sales difficult to quantify from public filings.

The remaining value is operational rather than patent-driven. Attractive positions depend on:

• Low-cost active pharmaceutical ingredient supply
• Reliable tablet manufacturing
• FDA compliance
• Contract access
• Wholesaler relationships
• Ability to avoid shortages
• Efficient regulatory maintenance

What generic entry risks exist for aspirin and pravastatin?

For aspirin, generic entry risk is effectively permanent and already embedded in the market. The principal risks are commercial:

• Private-label substitution
• Retailer margin compression
• Commodity input-cost increases
• Manufacturing recalls
• Product liability
• Declining preventive-use demand

For pravastatin, the main risk is continued price erosion and loss of volume to competing statins. A new Paragraph IV event would have limited strategic importance because the basic product is already generic.

Supply disruption can create temporary pricing opportunities, but these are not durable unless a supplier has a differentiated manufacturing or distribution position.

What manufacturing and intellectual-property barriers remain?

Aspirin has low technical barriers but requires control of impurity levels, stability, coating performance, and packaging. The main risks involve quality systems, supplier qualification, and scale.

Pravastatin manufacturing is more technically demanding than aspirin because the molecule is produced through fermentation-derived or semi-synthetic processes and requires control of stereochemistry, impurities, and active-ingredient consistency. Those manufacturing requirements can create operational barriers even when patent protection has expired.

The distinction is important:

• Aspirin has low IP barriers and low manufacturing complexity.
• Pravastatin has low IP barriers but higher process-control requirements.
• Neither product has a strong regulatory moat.
• Supply reliability can matter more than patent ownership.

What licensing deals affect aspirin and pravastatin?

Aspirin commercial arrangements are generally centered on trademarks, contract manufacturing, distribution, and regional consumer-health licensing. The Bayer trademark is commercially important, but it does not confer ownership of aspirin.

Pravastatin’s historical commercial model involved Bristol-Myers Squibb’s Pravachol franchise and related development and commercialization arrangements. Any current licensing value is limited because the product is generic and multiple suppliers can market equivalent products. Agreements may still cover regional distribution, authorized generic supply, or manufacturing, but they are unlikely to support high economic rents.

How strong is the patent estate for aspirin and pravastatin?

Factor	Aspirin	Pravastatin sodium
Composition patent strength	None	Expired
Formulation protection	Narrow and product-specific	Narrow and historical
Method-of-use protection	No material current barrier	Historical indications expired
Regulatory exclusivity	None of significance	Expired
Generic entry resistance	Very low	Very low
Manufacturing complexity	Low	Moderate
Commercial differentiation	Brand, packaging, combinations	Supply, quality, contracting

The patent estates for both medicines are weak from a current investment perspective. Pravastatin has more complex manufacturing economics, but that does not translate into a strong exclusionary right.

What are the likely generic launch scenarios?

Aspirin has no meaningful future generic-launch event. The market already operates under continuous multi-supplier competition.

For pravastatin, plausible commercial scenarios are:

1. Continued low-price supply with stable demand.
2. Further supplier consolidation as margins narrow.
3. Temporary price increases during shortages or manufacturing exits.
4. Volume migration to atorvastatin or rosuvastatin.
5. Niche retention in patients with tolerability or interaction concerns.

A new entrant would need manufacturing efficiency, reliable FDA compliance, and distribution access. Patent strategy would provide little advantage.

Key Takeaways

• Aspirin is a century-old, off-patent commodity with durable volume but limited pricing power.
• Bayer’s value in aspirin comes primarily from brand, distribution, and consumer recognition, not active-ingredient exclusivity.
• Pravastatin sodium lost its central patent protection in the mid-2000s and has been a mature generic for nearly two decades.
• Neither product has meaningful current biosimilar exposure or new-drug exclusivity.
• Pravastatin faces greater therapeutic substitution risk from atorvastatin and rosuvastatin.
• Aspirin revenue is broadly stable but difficult to isolate because manufacturers report it within larger consumer-health portfolios.
• Pravastatin revenue is low-margin and volume-driven, with manufacturing reliability more important than patent ownership.
• Current investment value lies in supply-chain execution, regulatory compliance, brand strength, and distribution rather than exclusivity.

FAQs

Is aspirin still patented by Bayer?

No. Bayer’s principal commercial protection is its trademark and brand equity. Aspirin as an active ingredient is long off patent.

Does pravastatin sodium still have Orange Book protection?

No material Orange Book patent protection remains for the core pravastatin sodium product. Historical Pravachol patents and exclusivities have expired.

Can a company launch a generic aspirin product without a Paragraph IV challenge?

Yes. Aspirin’s active ingredient has no meaningful current patent barrier. The regulatory pathway depends on the dosage form, labeling, and whether the product is marketed under an OTC monograph or an approved application.

Is pravastatin protected by manufacturing patents?

Historical process patents may have existed, but they do not create a broad current barrier to generic pravastatin supply. Manufacturers can use alternative processes if they meet quality and regulatory requirements.

Which drug has better long-term commercial prospects, aspirin or pravastatin?

Aspirin has the more durable volume base because of its broad OTC and cardiovascular uses. Pravastatin has a narrower and more substitution-exposed prescription market. Neither offers strong patent-driven growth.

References

Bayer AG. (2023). Annual report 2023. https://www.bayer.com/en/investors/annual-reports

U.S. Food and Drug Administration. (1991). Pravachol approval history and prescribing information. https://www.accessdata.fda.gov

U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book

U.S. Patent No. 4,346,227. (1982). Pravastatin and related compounds. United States Patent and Trademark Office.

U.S. Preventive Services Task Force. (2022). Aspirin use to prevent cardiovascular disease: Preventive medication. JAMA, 327(16), 1577-1584. https://doi.org/10.1001/jama.2022.4983