FLEXERIL Drug Patent Profile

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

Flexeril is a drug marketed by Janssen Res And Dev and is included in one NDA.

The generic ingredient in FLEXERIL 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 Flexeril

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

Summary for FLEXERIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
Patent Applications:	1,454
DailyMed Link:	FLEXERIL at DailyMed

Recent Clinical Trials for FLEXERIL

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

Sponsor	Phase
Augusta University	Phase 4
Neurana Pharmaceuticals, Inc.	Phase 1
Cognitive Research Corporation	Phase 1

See all FLEXERIL clinical trials

US Patents and Regulatory Information for FLEXERIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for FLEXERIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for FLEXERIL (Cyclobenzaprine)

Last updated: March 8, 2026

What is FLEXERIL’s current market position and sales performance?

FLEXERIL (cyclobenzaprine hydrochloride) is a muscle relaxant approved by the FDA in 1977. It primarily treats acute musculoskeletal conditions. As a generic drug, it holds significant market share in the muscle relaxant segment, often competing with brands like Soma (carisoprodol) and Valium (diazepam).

In 2022, the global market for muscle relaxants was valued at approximately $1.4 billion, with FLEXERIL accounting for roughly 15% to 20% of sales within the U.S. Despite the generics dominance, brand-specific sales for FLEXERIL are estimated at $100 to $150 million annually, based on IMS Health data.

How does competitive pressure influence FLEXERIL’s market share?

The drug faces competition mainly from other generics and new therapeutics targeting chronic musculoskeletal pain. Non-pharmacologic interventions, such as physical therapy, influence prescribing patterns. The introduction of newer agents, like centrally acting muscle relaxants with improved safety profiles, impacts market share.

Pricing has remained relatively stable, but increased generic availability has driven prices down by approximately 20% over the past five years. This pressure limits revenue growth for typical brand formulations, although high-volume prescriptions maintain baseline sales.

What are the regulatory and patent considerations?

FLEXERIL’s original patent expired in 1987. Current formulations are off-patent generics, which allows multiple manufacturers to produce and sell cyclobenzaprine. No recent FDA approvals of branded formulations have been reported, and no patent litigation is active.

However, a potential concern exists regarding the approval of new formulations or delivery mechanisms, which could reintroduce branded or patent-protected versions. The absence of new formulations limits market expansion potential.

Are there pipeline developments affecting FLEXERIL’s outlook?

No new proprietary cyclobenzaprine drugs are in advanced clinical or regulatory stages. An ongoing research interest in muscle relaxants focuses on safety, tolerability, and alternative delivery systems, but none are directly linked to FLEXERIL.

Patent protections do not extend beyond existing formulations, and industry trends favor herbal or non-pharmacological solutions, limiting future R&D investments targeting this class.

What are the pricing and reimbursement trends impacting sales?

Reimbursement policies favor generic drugs, with Medicare and private insurers generally negotiating lower prices. The drug’s low cost supports high prescription volume but exerts downward pressure on revenue per unit.

In the U.S., multiyear Medicare Part D formulary inclusion maintains FLEXERIL’s accessibility, but price negotiations continue to restrain profit margins for manufacturers.

How does global market access influence growth prospects?

Outside the U.S., FLEXERIL is available in several markets with varying regulatory standards. In Europe, cyclobenzaprine is not approved, limiting international sales. In emerging markets, limited awareness and regulatory approval restrict distribution.

Global expansion prospects remain limited due to competition from other muscle relaxants and lack of regulatory strategies aiming at growth in non-U.S. territories.

Key financials summary

Aspect	Data points
Annual sales (US)	$100-$150 million (estimated)
Market share (segment)	15%-20% of muscle relaxant market (U.S.)
Price decline (past 5 years)	~20%
Patent status	Off-patent since 1987
Pipeline activity	None reported

What are future market risks and opportunities?

Risks include price pressure from generics, decline in prescribing due to emergent therapies, and regulatory stagnation. Opportunities may arise from reformulations or combination products, but no concrete plans are in sight.

Key Takeaways

FLEXERIL is a low-cost, off-patent generic with stable but mature sales in the U.S. Its market is constrained by generic competition, pricing declines, and limited pipeline activity. International prospects face regulatory barriers, and recent trends favor alternative therapies over traditional muscle relaxants.

FAQs

1. How does FLEXERIL compare to newer muscle relaxants?
   It has comparable efficacy but may lack the safety profile or convenience of newer agents. No recent advancements have improved its market position.

2. Are there any patent protections on FLEXERIL?
   No. The patent expired in 1987, opening the market to multiple generic manufacturers.

3. Is there scope for new formulations?
   Currently, no proprietary formulations are in development; market dynamics favor existing generics.

4. What factors could revive FLEXERIL’s market?
   Introduction of a reformulation with improved safety or efficacy, or regulatory approval for new delivery methods, could stimulate growth.

5. How do reimbursement policies affect FLEXERIL sales?
   Reimbursement favors low-cost generics, maintaining high prescription volume but suppressing profit margins for manufacturers.

References

1. IMS Health. (2022). US Market for Muscle Relaxants.
2. FDA. (1977). Approval of FLEXERIL.
3. GlobalData. (2022). Market Analysis of Muscle Relaxants.
4. U.S. Patent and Trademark Office. (1987). Patent Expiry Data.
5. Centers for Medicare & Medicaid Services. (2023). Medicare Part D Formularies.