NIASPAN Drug Patent Profile

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

Niaspan is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in NIASPAN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Niaspan

A generic version of NIASPAN was approved as niacin by BARR on April 14^th, 2005.

Summary for NIASPAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	45
Patent Applications:	4,101
Drug Prices:	Drug price information for NIASPAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIASPAN
What excipients (inactive ingredients) are in NIASPAN?	NIASPAN excipients list
DailyMed Link:	NIASPAN at DailyMed

See drug prices for NIASPAN

See drug sales revenues for NIASPAN

Recent Clinical Trials for NIASPAN

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

Sponsor	Phase
Cortria Corporation	Phase 1
PPD	Phase 1
Pharmena North America	Phase 1

See all NIASPAN clinical trials

US Patents and Regulatory Information for NIASPAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-004	Jul 28, 1997		DISCN	Yes	No
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-003	Jul 28, 1997		DISCN	Yes	No
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-001	Jul 28, 1997		DISCN	No	No
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997		DISCN	Yes	No
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997		DISCN	No	No

Expired US Patents for NIASPAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	7,998,506
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-001	Jul 28, 1997	6,080,428
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	6,129,930
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-003	Jul 28, 1997	7,998,506
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	6,818,229
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-003	Jul 28, 1997	6,080,428

International Patents for NIASPAN

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

Country	Patent Number	Title	Estimated Expiration
Germany	69829042
Australia	6454598
European Patent Office	2319513
Canada	2591710
Norway	994248
Canada	2297756	PROCEDES DE TRAITEMENT PROPHYLACTIQUE DE SUJETS ENCLINS A L'HYPERLIPIDEMIE A L'AIDE D'UN AGENT INHIBANT LES BOUFFEES VASOMOTRICES AVANT D'ENTAMER UNE THERAPIE A BASE D'ACIDE NICOTINIQUE SOUS FORME DE DOSE QUOTIDIENNE UNIQUE DE MANIERE A REDUIRE LES BOUFFEES VASOMOTRICES PROVOQUEES PAR L'ACIDE NICOTINIQUE (METHODS OF PRETREATING HYPERLIPIDEMIC INDIVIDUALS WITH A FLUSH INHIBITING AGENT PRIOR TO THE START OF SINGLE DAILY DOSE NICOTINIC ACID THERAPY TO REDUCE FLUSHING PROVOKED BY NICOTINIC ACID)

NIASPAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NIASPAN

Overview of NIASPAN

NIASPAN, a brand name for extended-release niacin, is a medication used to manage high cholesterol and reduce the risk of cardiovascular events. It is a form of vitamin B3 (niacin) and is often prescribed in conjunction with other lipid-lowering therapies.

Historical Usage and Prescription Trends

Between 2002 and 2009, the use of niacin, including NIASPAN, saw a significant increase. In the United States, niacin prescriptions rose by 191.2% to reach 696,000 prescriptions per month by December 2009. During the same period, NIASPAN, developed by Abbott Laboratories (now AbbVie), accounted for 81.6% of all niacin prescriptions in the U.S.[4].

Market Share and Competition

In the U.S. market, NIASPAN was a dominant player in the niacin segment, but it faced competition from other combination therapies like Advicor (niacin plus lovastatin) and Simcor (niacin plus simvastatin), also developed by AbbVie. However, NIASPAN remained the leading niacin product, with a significant market share[4].

Financial Performance

Revenue and Sales

In the early 2010s, NIASPAN generated substantial revenue for AbbVie. However, by 2014, the sales of NIASPAN began to decline due to generic competition. For instance, in the second quarter of 2014, NIASPAN sales were $21 million, down significantly from previous years due to the loss of exclusivity and the introduction of generic alternatives[5].

Impact of Generic Competition

The decline in NIASPAN sales was largely attributed to the expiration of its patent and the subsequent entry of generic versions into the market. This competition led to a significant drop in revenue, as generic drugs are generally cheaper and attract a larger market share. By 2014, the sales of NIASPAN and another related product, TriCor/Trilipix, were down by 83.8% and 83.0%, respectively, compared to the previous year[5].

Market Dynamics

Distribution Channels

The distribution of NIASPAN, like other pharmaceuticals, is heavily reliant on pharmacies and drug stores. These channels dominated the market for niacin and niacinamide products, accounting for around 64.5% of the market share in 2021[1].

Geographical Performance

The U.S. was a key market for NIASPAN, with the product contributing significantly to the overall niacin and niacinamide market in North America. In 2021, the U.S. led the North American market with a share of around 21.1%[1].

Regulatory Environment

The approval and regulatory environment play a crucial role in the market dynamics of pharmaceutical products like NIASPAN. For example, the approval of combination therapies like Simcor (niacin plus simvastatin) by regulatory bodies such as the U.S. FDA influenced the market trajectory of NIASPAN[3].

Future Outlook

Market Growth

Despite the decline in NIASPAN sales due to generic competition, the overall market for niacin and niacinamide is expected to grow. The global niacin and niacinamide market is projected to grow at a CAGR of 5.2% from 2022 to 2032, driven by increasing consumer demand for health supplements and skincare products containing niacin and niacinamide[1].

Emerging Markets

Emerging markets, such as India, are expected to contribute significantly to the growth of the niacin and niacinamide market. India accounted for a market share of 15.3% in 2021 and is anticipated to witness lucrative growth opportunities due to the rapid development of the healthcare sector and increasing awareness of skincare and health supplements[1].

Key Takeaways

• NIASPAN was a leading brand in the niacin market but faced significant decline due to generic competition.
• The global niacin and niacinamide market is expected to grow at a CAGR of 5.2% from 2022 to 2032.
• Emerging markets like India are expected to drive future growth.
• Distribution through pharmacies and drug stores remains a dominant channel.
• Regulatory approvals and the introduction of combination therapies influence market dynamics.

FAQs

What is NIASPAN used for?

NIASPAN is an extended-release form of niacin used to manage high cholesterol and reduce the risk of cardiovascular events.

Why did NIASPAN sales decline?

NIASPAN sales declined significantly due to the loss of patent exclusivity and the introduction of generic versions of the drug.

What is the current market trend for niacin and niacinamide?

The global niacin and niacinamide market is expected to grow at a CAGR of 5.2% from 2022 to 2032, driven by increasing demand for health supplements and skincare products.

Which regions are driving the growth of the niacin and niacinamide market?

The U.S., India, China, Japan, and Germany are the top countries driving the demand for the niacin and niacinamide market.

How does generic competition affect pharmaceutical products like NIASPAN?

Generic competition significantly reduces the sales of branded pharmaceutical products by offering cheaper alternatives, leading to a loss of market share and revenue for the original brand.

Sources

1. Future Market Insights, "Niacin and Niacinamide Market Size, Share, Outlook & Trend - 2032"
2. AbbVie, "AbbVie Reports Fourth-Quarter and Full-Year 2013 Financial Results"
3. Solvay Group, "Consistent implementation of our strategy for ... - November 2008"
4. JAMA Network, "Use of Niacin in the United States and Canada"
5. AbbVie, "AbbVie Reports Second-Quarter 2014 Financial Results"