ANAPROX Drug Patent Profile

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

Anaprox is a drug marketed by Atnahs Pharma Us and is included in one NDA.

The generic ingredient in ANAPROX is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Anaprox

A generic version of ANAPROX was approved as naproxen sodium by CONTRACT PHARMACAL on January 13^th, 1997.

Summary for ANAPROX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	13
Patent Applications:	7,098
Drug Prices:	Drug price information for ANAPROX
DailyMed Link:	ANAPROX at DailyMed

See drug prices for ANAPROX

Recent Clinical Trials for ANAPROX

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

Sponsor	Phase
Northwestern Medical Group	Phase 2
Shirley Ryan AbilityLab	Phase 2
Apkar Apkarian	Phase 4

See all ANAPROX clinical trials

US Patents and Regulatory Information for ANAPROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	AB	RX	Yes	Yes

Expired US Patents for ANAPROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982

International Patents for ANAPROX

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

Country	Patent Number	Title	Estimated Expiration
Australia	1006270
Belgium	734275
Belgium	747812
Belgium	751445
Belgium	752627

Supplementary Protection Certificates for ANAPROX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Market Dynamics and Financial Trajectory for ANAPROX (Anaprox)

Last updated: March 17, 2026

What is the current market position of ANAPROX?

ANAPROX is a nonsteroidal anti-inflammatory drug (NSAID) primarily used to treat pain, fever, and inflammation. Its active ingredient is naproxen. Market data indicates high saturation in outpatient pain management settings, with steady demand in chronic and acute conditions.

Market Share and Competition

• ANAPROX's estimated market share in the NSAID segment in the U.S. stands at approximately 15-20% among OTC and prescription NSAIDs.
• It faces competition from ibuprofen, diclofenac, and other naproxen formulations. Its generic versions account for roughly 60% of sales, reducing revenue per unit.
• Brand-specific sales generated approximately $150 million annually in the U.S., representing a segment of the broader NSAID market valued at over $1.2 billion (IQVIA, 2023).

What are recent trends affecting ANAPROX?

Regulatory Changes and Patent Status

• No recent patent protections remain for the original formulation, leading to increased generic competition.
• The absence of new formulations or formulations with patent protection limits the opportunity for premium pricing.

Prescription and OTC Market Trends

• A shift toward OTC availability has increased accessibility, spearheading a decline in prescription-based sales.
• OTC sales constitute around 70-75% of ANAPROX's total revenue.

Health Policy and Safety Profiles

• Updated safety guidelines to limit NSAID use in patients with cardiovascular risks influence prescribing patterns.
• Growing awareness of NSAID-related side effects tempers potential sales growth.

What is the financial trajectory likely to look like?

Year	Market Size (USD)	Narrative
2023	$150 million (U.S.)	Stable with slight decline due to competition and safety concerns
2024	$140 million	Possible 6-7% decrease, influenced by reformulations and stricter guidelines
2025	$130 million	Continued stabilization or decline, unless new formulation enters market
2026	$125 million	Base case; strategic shift required to maintain revenue levels

Revenue Drivers and Barriers

Drivers:

• Ongoing OTC demand driven by cost-effectiveness and familiarity.
• Growing chronic pain management needs, especially in aging populations.

Barriers:

• Increased competition from generics.
• Regulatory pressures and safety concerns that may restrict sales volume.
• Limited innovation or new formulations.

Investment and R&D Outlook

• Limited R&D investments are directed toward reformulated NSAIDs with improved safety profiles.
• Companies exploring topical NSAID formulations or fixed-dose combination drugs may impact the market dynamics for traditional ANAPROX.

How do external factors influence financial outcomes?

Regulatory Environment

• The U.S. FDA continues to monitor NSAID safety, potentially imposing new restrictions or warnings.
• International regulation varies, impacting global sales.

Payer and Consumer Behavior

• Cost sensitivity favors generic products, pressuring branded ANAPROX revenues.
• Consumer preference shifting toward non-NSAID pain management alternatives, such as acetaminophen or non-pharmacological therapies.

Patent Landscape

• Patent expirations for various formulations have catalyzed generic entry, placing price pressure on ANAPROX.

Summary of Market Conditions

Factor	Impact on ANAPROX	Effect on Financial Trajectory
Patent expiration	Negative	Revenue decline
Generic competition	Negative	Margin compression
OTC availability	Mixed	Sustains volume, lowers margins
Safety regulations	Negative	Limits prescribing, reduces sales

Key Takeaways

• ANAPROX operates within a mature NSAID market with constrained growth prospects.
• Patent expirations and generics dominate, pressuring revenue.
• Market share remains stable with OTC demand, but growth is limited.
• Revenue is projected to decline modestly without significant innovation or formulation breakthroughs.
• External health policies and safety concerns are primary external risks.

FAQs

1. Will ANAPROX see renewed growth through new formulations?
Current trends show limited R&D activity focused on reformulations. Unless pharmaceutical companies develop NSAIDs with enhanced safety profiles, significant growth remains unlikely.

2. How does generic competition affect ANAPROX's profitability?
Generic entry reduces price premiums, leading to margin compression and potential revenue declines.

3. What is the impact of safety concerns on ANAPROX sales?
Safety concerns, especially related to cardiovascular and gastrointestinal risks, lead to cautious prescribing, limiting sales growth.

4. Can international markets offset U.S. sales declines?
Market penetration varies; emerging markets may offer growth opportunities but are affected by regulatory and reimbursement environments.

5. Is there potential for over-the-counter (OTC) sales to expand further?
Yes, OTC sales continue to dominate, but saturation and safety warnings cap upside potential.

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References

[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2022). NSAID Safety Guidelines.