AXERT Drug Patent Profile

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

Axert is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in AXERT is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axert

A generic version of AXERT was approved as almotriptan malate by TEVA PHARMS USA on July 7^th, 2015.

Summary for AXERT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	358
Drug Prices:	Drug price information for AXERT
What excipients (inactive ingredients) are in AXERT?	AXERT excipients list
DailyMed Link:	AXERT at DailyMed

See drug prices for AXERT

Paragraph IV (Patent) Challenges for AXERT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXERT	Tablets	almotriptan malate	6.25 mg and 12.5 mg	021001	1	2005-12-08

US Patents and Regulatory Information for AXERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001		DISCN	Yes	No
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001		DISCN	Yes	No

Expired US Patents for AXERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001	5,565,447*PED
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001	5,565,447*PED

International Patents for AXERT

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9305589
Egypt	20340	Process for preparing of new indol derivatives
Finland	941413
Japan	H06511261
Norway	180231
Russian Federation	2117667	INDOLE DERIVATIVES, METHOD OF THEIR SYNTHESIS, PHARMACEUTICAL COMPOSITION SHOWING SELECTIVE BINDING ACTIVITY WITH RESPECT TO 5--HTID RECEPTORS AND VASOCONSTRICTIVE EFFECT ASSOCIATED WITH 5-HTID AGONISTIC EFFECT AND A METHOD OF SELECTIVE BINDING 5--HTID RECEPTORS OR AGONISTIC EFFECT ON 5-HTID RECEPTORS

Supplementary Protection Certificates for AXERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0605697	2001 00005	Denmark		DKCTFF CA 2001 00005, 20010226, EXPIRES: 20150329
0605697	9/2001	Austria		PRODUCT NAME: ALMOTRIPTAN UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE; NAT. REGISTRATION NO/DATE: 1-23957, 1-23958 20010131; FIRST REGISTRATION: ES 62877 19991223
0605697	C00605697/01	Switzerland		FORMER OWNER: LABORATORIOS ALMIRALL, S.A., ES
0605697	C300053	Netherlands		PRODUCT NAME: ALMOTRIPTAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH GESCHIKT ZOUT, IN HET BIJZONDER HET WATERSTOFMALAAT; REGISTRATION NO/DATE: RVG 25415 - RVG 25416 20010309
0605697	SPC/GB01/008	United Kingdom		PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
0605697	SPC003/2001	Ireland		SPC003/2001: 20041230, EXPIRES: 20141222

Market Dynamics and Financial Trajectory for Axert (Almotriptan Malate)

Overview of Axert

Axert, also known as almotriptan malate, is a prescription medication used for the acute treatment of migraine attacks in adults. It belongs to the class of triptan drugs, which work by constricting blood vessels and blocking pain pathways in the brain.

Market Size and Growth

The migraine therapeutics market, within which Axert operates, is experiencing significant growth. The global migraine therapeutics market is projected to reach USD 6.16 billion by 2024 and grow at a CAGR of 6.84% to reach USD 8.58 billion by 2029[1].

Regional Performance

• North America: This region holds the largest market share in the migraine therapeutics market, driven by the high prevalence of migraines and the adoption of novel therapeutics. In the United States, for example, 17.1% of women and 5.6% of men report having migraine symptoms, which significantly contributes to the market size[1].
• Asia Pacific: This region is expected to be the fastest-growing market over the forecast period, driven by increasing awareness and healthcare spending[1][3].

Generic Market Impact

Teva's Generic Launch

Teva Pharmaceutical Industries Ltd. was the first to receive approval and launch generic Axert (almotriptan malate) tablets in the United States. This move was significant as it marked the first generic version of Axert, providing a more affordable alternative to the brand-name drug. The generic launch was facilitated by Teva's submission of an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, which allowed them to challenge the patents associated with the brand drug[4].

Financial Impact of Generic Competition

The introduction of generic Axert has likely impacted the financial trajectory of the brand-name drug. Generic versions typically reduce the market share and revenue of the original brand due to their lower pricing. For instance, the annual sales of brand-name Axert were approximately $31 million in the United States as of March 2015. The launch of the generic version would have reduced these sales figures as patients and healthcare providers opt for the more cost-effective generic alternative[4].

Pricing and Revenue

Pre-Generic Pricing

Before the generic launch, Axert was priced as a brand-name drug, which generally commands a higher price point compared to generics. This pricing strategy allowed the original manufacturer to capture significant revenue from the market.

Post-Generic Pricing and Revenue

With the entry of generic Axert, the pricing dynamics have changed. Generic drugs are typically priced lower than their brand-name counterparts, which can lead to a reduction in revenue for the original manufacturer. However, the overall market size for migraine therapeutics continues to grow, driven by increasing prevalence and new treatment options, which can offset some of the revenue loss due to generic competition[1][3].

Competitive Landscape

Key Players

The migraine therapeutics market is highly competitive, with several key players including Amgen, Teva Pharmaceutical Industries Ltd, GlaxoSmithKline, Eli Lilly and Company, and Bausch Health. These companies are involved in various strategic activities such as product launches, approvals, and mergers and acquisitions to maintain their market position[1].

Recent Developments

Recent developments in the market include the approval and launch of new migraine treatments. For example, Lundbeck's VYEPTI (eptinezumab-jjmr) and Biohaven's NURTEC ODT (rimegepant) have been approved by the FDA for the preventive and acute treatment of migraines, respectively. These new treatments further intensify the competition in the market[1].

Regulatory Environment

FDA Approvals and Certifications

The regulatory environment plays a crucial role in the market dynamics of Axert. The FDA approval process, including the ANDA with Paragraph IV certification, allows generic manufacturers to enter the market. This process ensures that generic drugs meet the same safety and efficacy standards as the brand-name drugs, providing patients with affordable alternatives[4].

Patient and Market Trends

Increasing Prevalence and Awareness

The growing prevalence of migraines and increasing awareness about treatment options are driving the market growth. Telemedicine and remote consultations, personalized medicine approaches, and healthcare policy changes are also contributing to the expansion of the migraine therapeutics market[3].

Targeted Therapies and Digital Therapeutics

The market is shifting towards targeted therapies, such as CGRP receptor antagonists, and digital therapeutics. These advancements are improving treatment outcomes and patient satisfaction, further driving the market's financial trajectory[3].

Key Takeaways

• The global migraine therapeutics market is expected to grow significantly, driven by increasing prevalence and new treatment options.
• The launch of generic Axert has impacted the revenue of the brand-name drug but has also expanded access to migraine treatment.
• North America dominates the market, while Asia Pacific is the fastest-growing region.
• Key players are engaging in strategic activities to maintain market share.
• Regulatory approvals and certifications are crucial for market entry.

FAQs

What is Axert used for?

Axert (almotriptan malate) is used for the acute treatment of migraine attacks in adults.

Who launched the generic version of Axert in the United States?

Teva Pharmaceutical Industries Ltd. was the first to receive approval and launch the generic version of Axert in the United States.

How has the generic launch affected the brand-name Axert?

The generic launch has likely reduced the market share and revenue of the brand-name Axert due to the lower pricing of the generic version.

What is the current market size of the global migraine therapeutics market?

The global migraine therapeutics market is expected to reach USD 6.16 billion by 2024.

Which region is expected to be the fastest-growing in the migraine therapeutics market?

The Asia Pacific region is expected to be the fastest-growing in the migraine therapeutics market over the forecast period.

Sources

1. Mordor Intelligence: Migraine Therapeutics Market Size & Share Analysis
2. Antares Pharma, Inc.: FORM 10-K
3. The Business Research Company: Migraine Drugs Market Report 2024, Research And Forecast
4. Teva Pharmaceutical Industries Ltd.: Teva First to Receive Approval and Launch Generic Axert® Tablets in the United States
5. Colorado Department of Health Care Policy and Financing: Drug Utilization Review Board Minutes, February 2024