ANAPROX DS Drug Patent Profile

When do Anaprox Ds patents expire, and what generic alternatives are available?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Anaprox Ds

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

Summary for ANAPROX DS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	13
Patent Applications:	6,075
Drug Prices:	Drug price information for ANAPROX DS
DailyMed Link:	ANAPROX DS at DailyMed

See drug prices for ANAPROX DS

Recent Clinical Trials for ANAPROX DS

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 DS clinical trials

Pharmacology for ANAPROX DS

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for ANAPROX DS

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 DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	AB	RX	Yes	Yes

Expired US Patents for ANAPROX DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	3,998,966
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	4,009,197
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	4,001,301

International Patents for ANAPROX DS

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5011910
Switzerland	520645	Verfahren zur Herstellung von a-(2-Naphthyl)- bzw. a-(3,4-Dihydro-2-naphthyl)-a-difluormethylessigsäuren
United Kingdom	1301445
Spain	410167
Spain	410156

Supplementary Protection Certificates for ANAPROX DS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	122012000051	Germany		PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105

ANAPROX DS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Anaprox DS (Naproxen)

Overview of Anaprox DS

Anaprox DS, a brand name for the nonsteroidal anti-inflammatory drug (NSAID) naproxen, is widely used for treating various pain and inflammatory conditions. It is marketed by Roche as a prescription drug and by Bayer AG as an over-the-counter (OTC) medication under different brand names such as Aleve and Midol Extended Relief[1].

Market Drivers

Availability and Profiling

The availability of naproxen as both a prescription and OTC drug significantly drives its market. The well-established profiling of its benefits and risks has made it a preferred choice for many consumers[1].

Increasing Geriatric Population

The rise in the geriatric population, which is more prone to arthritis and other painful conditions, propels the demand for naproxen. Conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis are more common among older adults, contributing to the growth of the naproxen market[1].

Pain Relief Across Various Conditions

Naproxen is not limited to arthritis; it is also used for muscle strain relief, back pain, knee pain, and other painful conditions. This broad applicability boosts its market demand[1].

Market Restraints

Cardiovascular and Gastrointestinal Risks

The increased risk of cardiovascular events such as heart attacks and strokes, as well as abdominal bleeding or ulcers, especially in older populations, acts as a significant restraint. These risks make some patients and healthcare providers opt for alternative medications with lower side effect profiles[1].

Pregnancy and Allergic Reactions

Naproxen is advised against in late pregnancy due to the risk of premature closing of the ductus arteriosus. Additionally, allergic reactions can occur, further limiting its use in certain patient groups[1].

Competition from Other NSAIDs

The availability of other NSAIDs and steroids with potentially lower risks of abdominal ulcers or allergic reactions competes with naproxen in the market. This competition can hamper the growth of the naproxen market[1].

Market Segmentation

Disease Indication

The naproxen market is segmented based on disease indication, including osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, juvenile arthritis, bursitis, menstrual cramps, gout, and tendonitis[1].

Formulation

Naproxen is available in various formulations, primarily oral tablets and liquid suspension[1].

Distribution Channel

The market is segmented by distribution channels such as hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms[1].

Geographic Region

The market is segmented geographically into Asia Pacific (APAC), Europe, Middle East & Africa (MEA), North America (NA), and Latin America (LA)[1].

Financial Trajectory

Market Size and Growth

The global naproxen market volume was approximately 15 thousand tonnes in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.5% until 2034[4].

Pricing and Cost

The cost of Anaprox-DS sodium 550 mg oral tablets can range from $30.65 to $52.99 for a supply of 6 to 20 tablets, depending on the pharmacy and any discounts applied. Generic versions are available at significantly lower prices, starting from around $7.50 for 6 tablets[2].

Revenue and Sales

The revenue from naproxen sales is substantial, driven by its widespread use. The economic burden of conditions treated by naproxen, such as osteoarthritis, is estimated to be over $461 billion annually in direct and indirect healthcare costs[5].

Competitive Landscape

Key Players

Major players in the naproxen market include Roche (Genentech) and Bayer AG. These companies have a strong presence in the global market, with their brands such as Naprosyn, Anaprox, Aleve, and Midol Extended Relief[1].

Generic Competition

The availability of generic versions of naproxen increases competition, making the drug more affordable and accessible to a broader audience. This competition can affect the pricing and market share of branded versions[2].

Patient Assistance and Discounts

Discount Cards and Coupons

Patients can use discount cards and coupons to reduce the cost of Anaprox-DS. For example, the Drugs.com Discount Card can save up to 80% on prescription medicines, including Anaprox-DS[2].

Patient Assistance Programs

While there are no specific patient assistance programs for Anaprox-DS, patients may be eligible for other programs that offer cost-free or discounted medicines, depending on their income and insurance status[2].

Future Outlook

Increasing Demand

The demand for naproxen is expected to increase due to the growing prevalence of arthritis and other painful conditions. This trend is likely to continue, driven by an aging population and the need for effective pain management[1][4].

Regulatory and Safety Considerations

Regulatory bodies continue to monitor the safety profile of naproxen, and any changes in guidelines or warnings could impact its market dynamics. However, its well-established use and benefits are likely to sustain its market position[1].

Key Takeaways

• Market Growth: The naproxen market is expected to grow at a CAGR of 5.5% until 2034.
• Key Drivers: Availability as both prescription and OTC, increasing geriatric population, and broad applicability.
• Restraints: Cardiovascular and gastrointestinal risks, pregnancy concerns, and competition from other NSAIDs.
• Segmentation: By disease indication, formulation, distribution channel, and geographic region.
• Financials: Significant revenue driven by high demand and widespread use.
• Competitive Landscape: Strong presence of Roche and Bayer AG, with generic competition affecting pricing.

FAQs

Q: What are the primary uses of Anaprox DS?

A: Anaprox DS is primarily used for treating conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, back pain, and menstrual cramps.

Q: What are the potential side effects of Anaprox DS?

A: Potential side effects include cardiovascular events like heart attacks and strokes, abdominal bleeding or ulcers, and allergic reactions.

Q: Is Anaprox DS available as a generic?

A: Yes, generic versions of naproxen are available and are significantly cheaper than the branded version.

Q: How does the cost of Anaprox DS compare to its generic version?

A: The cost of Anaprox-DS can range from $30.65 to $52.99 for 6-20 tablets, while generic versions start from around $7.50 for 6 tablets.

Q: What are the market projections for the naproxen market?

A: The global naproxen market is expected to grow at a CAGR of 5.5% until 2034, with a market volume projected to increase significantly.

Sources

1. Transparency Market Research - Naproxen Market Insight and Trends 2024
2. Drugs.com - Anaprox-DS Prices, Coupons, Copay Cards & Patient Assistance
3. Drug Patent Watch - Generic NAPROXEN SODIUM INN entry, pharmaceutical patent
4. ChemAnalyst - Naproxen Market Size, Share, Growth and Forecast to 2034
5. VA/DoD Clinical Practice Guideline - VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE NON-SURGICAL MANAGEMENT OF OSTEoARTHritis