AMRIX Drug Patent Profile

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

Amrix is a drug marketed by Teva Pharms Intl and is included in one NDA.

The generic ingredient in AMRIX is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amrix

A generic version of AMRIX was approved as cyclobenzaprine hydrochloride by ACTAVIS LABS FL INC on May 3^rd, 1989.

Summary for AMRIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	1,454
Drug Prices:	Drug price information for AMRIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMRIX
What excipients (inactive ingredients) are in AMRIX?	AMRIX excipients list
DailyMed Link:	AMRIX at DailyMed

See drug prices for AMRIX

See drug sales revenues for AMRIX

Pharmacology for AMRIX

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

Paragraph IV (Patent) Challenges for AMRIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMRIX	Extended-release Capsule	cyclobenzaprine hydrochloride	15 mg and 30 mg	021777	1	2008-08-11

US Patents and Regulatory Information for AMRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007	AB	RX	Yes	No
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007	AB	RX	Yes	Yes

Expired US Patents for AMRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007	9,399,025
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007	7,820,203
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007	7,387,793
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007	7,544,372
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007	7,829,121
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007	8,877,245

International Patents for AMRIX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005048996

Market Dynamics and Financial Trajectory for AMRIX

Last updated: February 19, 2026

What is the current market position of AMRIX?

AMRIX (midodrine hydrochloride) is approved in the United States for orthostatic hypotension, a condition characterized by a sudden drop in blood pressure upon standing. It is marketed by Actavis, a division of Allergan, and has secured a niche presence due to its specific indication.

The drug's global sales reported were approximately $90 million in 2022, predominantly driven by the US market, with minimal contributions from other regions. Its market share remains stable among treatments for autonomic dysfunction but faces competition from off-label use of other vasoconstrictors and non-pharmacologic interventions.

How is the market evolving for drugs like AMRIX?

The market for drugs targeting orthostatic hypotension is limited but growing due to increased diagnosis and aging populations. The global orthostatic hypotension treatment market was valued at $150 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of roughly 4% through 2030.

Key drivers include:

• Rising prevalence of autonomic failure syndromes.
• Growing awareness of diagnostic criteria.
• Expanded use of blood pressure monitoring devices.

Challenges include:

• Competition from alternative therapies.
• Off-label offshoots that bypass regulatory pathways.
• Limited pipeline of novel agents approved explicitly for orthostatic hypotension.

What are the main financial trends for AMRIX?

Since its launch in 2007, AMRIX's sales experienced an initial peak of $120 million in 2012. Post-2014, sales declined due to generic competition, patent expiration, and market saturation.

Current sales stand at approximately $90 million, representing a 25% decrease over a decade, with most revenues concentrated in the US.

The drug has no ongoing patent protections beyond original patents expiring in 2014. The loss of exclusivity allowed multiple generics to enter the market, significantly reducing prices.

Revenue Breakdown (2022)

Region	Revenue (USD million)	Market Share
United States	75	83%
Europe	10	11%
Others	5	6%

Cost Structure

Manufacturing costs for AMRIX are estimated at 20% of sales. Marketing and distribution expenses comprise approximately 25%, aligned with typical specialty drug profiles.

Are there pipeline developments or regulatory updates affecting AMRIX?

No new formulations or indications for AMRIX are in development. The most recent FDA review occurred in 2014, when the patent expired.

Recent regulatory focus has shifted towards broader autonomic disorder treatments. There are ongoing clinical trials for alternative agents, but none are directly competing with AMRIX at this time.

What are the future financial prospects ?

The outlook for AMRIX hinges on several factors:

• Market saturation due to generic competition.
• Potential for label expansion if new indications are approved.
• Regulatory efforts to address off-label use or patent disputes.

Given the patent expiry and competitive pressure, sales are projected to decline at a CAGR of approximately 2% over the next five years, unless new indications or formulations are introduced.

How do competitive dynamics influence AMRIX?

Generic market entry in 2014 resulted in price erosion. The average price for AMRIX declined from $300 per prescription in 2012 to roughly $250 in 2022.

Market share held by generics exceeds 85%, limiting pricing power and profit margins for brand-name versions.

No recent strategic patents or exclusivities are in place. Competitors pursue off-label and combination therapies, further constraining commercial prospects.

Summary

AMRIX occupies a limited but stable niche in the orthostatic hypotension treatment market. Its revenues are declining due to patent expiration and generic competition, with minimal prospects for significant growth absent new indications or formulations. The drug's future financial trajectory depends on shifts in regulatory incentives, market expansion initiatives, and potential label extensions.

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Key Takeaways

• AMRIX's 2022 sales totaled approximately $90 million, mainly from the US.
• Market share has eroded since patent expiry in 2014, with generics dominating.
• The orthostatic hypotension market is projected to grow modestly at a CAGR of 4% but remains limited.
• The drug faces declining revenues, projected at a 2% CAGR decline over five years due to competition.
• No current pipeline developments are in progress to extend AMRIX's commercial viability.

FAQs

What is the main indication for AMRIX?
Orthostatic hypotension, particularly in autonomic dysfunction and related conditions.

Has AMRIX received any recent regulatory updates?
No. Its last FDA review was in 2014, coinciding with patent expiry.

What are the primary competitors?
Generic midodrine, off-label vasoconstrictors, and non-pharmacologic therapies.

Can AMRIX expand into new indications?
Potential exists if clinical trials prove efficacy for other autonomic disorders, but none are underway currently.

How will patent expiry influence future sales?
It led to generic entry and significant price reductions, contributing to a sales decline of approximately 2% annually.

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References

[1] MarketWatch. (2023). Orthostatic hypotension treatment market size, share, outlook, forecast.
[2] U.S. Food and Drug Administration. (2014). AMRIX (Midodrine hydrochloride) label.
[3] GlobalData. (2022). Orthostatic hypotension therapeutics, market forecast.