JALYN Drug Patent Profile

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

Jalyn is a drug marketed by Waylis Therap and is included in one NDA.

The generic ingredient in JALYN is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jalyn

A generic version of JALYN was approved as dutasteride; tamsulosin hydrochloride by PH HEALTH on February 26^th, 2014.

Summary for JALYN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	32
Drug Prices:	Drug price information for JALYN
What excipients (inactive ingredients) are in JALYN?	JALYN excipients list
DailyMed Link:	JALYN at DailyMed

See drug prices for JALYN

See drug sales revenues for JALYN

Paragraph IV (Patent) Challenges for JALYN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JALYN	Capsules	dutasteride; tamsulosin hydrochloride	0.5 mg/0.4 mg	022460	1	2010-10-26

US Patents and Regulatory Information for JALYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	AB	RX	Yes	No

Expired US Patents for JALYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010

International Patents for JALYN

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

Country	Patent Number	Title	Estimated Expiration
Finland	961231
Slovenia	0719278
Australia	685167
China	1057771
Netherlands	300122
Greece	3032198

Supplementary Protection Certificates for JALYN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0719278	C300122	Netherlands		PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719
0719278	SPC/GB03/018	United Kingdom		PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117
0719278	03C0030	France		PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
0719278	PA2003007	Lithuania		PRODUCT NAME: DUTASTERIDUM (17BETA-N(2,5-BIS(TRIFLUORMETIL)FENILKARBAMOIL-4-AZA-5ALFA-ANDROST-1-EN-3-ONAS), PASIRINKTINAI FARMACISKAI TINKAMO SOLVATO FORMOJE; REGISTRATION NO/DATE: 03/8183/7 20030909
0719278	300122	Netherlands
0719278	PA2003007,C0719278	Lithuania		PRODUCT NAME: DUTASTERIDUM (17BETA-N(2,5-BIS(TRIFLUORMETIL)FENILKARBAMOIL-4-AZA-5ALFA-ANDROST-1-EN-3-ONAS), PASIRINKTINAI FARMACISKAI TINKAMO SOLVATO FORMOJE; REGISTRATION NO/DATE: 03/8183/7 20030909

Market Dynamics and Financial Trajectory for JALYN: A Comprehensive Analysis

Last updated: August 11, 2025

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Introduction

JALYN (dutasteride and tamsulosin), developed by Evofem Biosciences, is a combination medication approved in the United States primarily for the treatment of benign prostatic hyperplasia (BPH). Since its FDA approval, JALYN has navigated a complex landscape shaped by market demand, competitive pressures, regulatory considerations, and evolving healthcare dynamics. This analysis outlines the current market landscape, strategic factors influencing its financial trajectory, and future outlook prospects for JALYN within the pharmaceutical sector.

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Market Overview and Therapeutic Demand

Benign Prostatic Hyperplasia (BPH):
BPH affects over 50 million men in the United States alone, with prevalence increasing with age—approximately 50% of men aged 51–60 and up to 90% over 80 years old display symptoms [1]. The condition leads to urinary retention, decreased quality of life, and potential renal complications, prompting a persistent demand for effective therapeutics.

Therapeutic Options and the Role of JALYN:
The standard of care involves monotherapies such as alpha blockers (e.g., tamsulosin) or 5-alpha-reductase inhibitors (such as dutasteride or finasteride). Combination therapies, like JALYN, emerged to enhance symptomatic relief and reduce progression risks, leveraging the synergistic effects of dual-mechanism action.

Market Size and Growth:
The global BPH therapeutics market was valued at approximately USD 4.2 billion in 2021 and projected to grow at a CAGR of over 3% through 2030 [2]. In the U.S., the market's expansion is driven by aging demographics, increased awareness, and a preference for combination therapies.

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Competitive Landscape

Key Players:
JALYN competes with monotherapies and other combination products, including:

• Individual agents: Tamsulosin (Flomax), dutasteride (Avodart), finasteride.
• Combination therapies: Commercially available fixed-dose combinations like - Silodosin+dutasteride (e.g., Jalyn's primary market competitors).
• Emerging oral and minimally invasive treatments: Including UroLift and other device-based solutions.

Market Position and Differentiation:
JALYN’s unique proposition lies in combining two well-established agents into a single capsule, simplifying medication regimens and possibly increasing adherence, which is a significant factor in BPH management success.

Pricing and Reimbursement:
Pricing strategies are influenced by competitive pricing, insurance reimbursements, and formulary placements. As a branded combination product, JALYN's pricing is higher than individual generic agents, potentially impacting adoption rates amid payer scrutiny.

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Regulatory and Prescriptive Dynamics

Regulatory Guidance:
JALYN received FDA approval in 2018, with subsequent updates supporting its use. However, regulatory considerations such as labeling, post-marketing surveillance, and risk management influence its commercial trajectory.

Physician and Patient Acceptance:
Physician preference leans toward proven monotherapies, with conservative adoption of newer combinations. Patient adherence remains critical, especially since BPH therapy often involves chronic management.

Payer and Insurance Dynamics:
Coverage decisions hinge upon clinical evidence, comparative effectiveness, and cost-benefit analyses. Payers are increasingly favoring generic options, which could impact JALYN's market share.

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Financial Trajectory and Market Penetration

Initial Sales Performance:
Evofem’s initial commercial rollout showed modest uptake, attributable to several factors:

• Limited awareness and prescriber familiarity.
• High price points compared to generics.
• Competition from established monotherapies and upcoming generics.

Growth Factors:
The financial outlook for JALYN depends on:

• Market penetration: Expanding prescriber confidence and patient acceptance.
• Patent and exclusivity status: As the patent life progresses, biosimilar entries could erode pricing power.
• Regulatory updates: Potential for expanded indications or label changes to boost utilization.
• Technological innovations: New delivery mechanisms or combination therapies could reshape the competitive landscape.

Forecasting Models:
Industry analysts project that if JALYN captures even 5-10% of the BPH market within five years, revenues could approximate hundreds of millions USD annually. However, actual sales remain contingent upon strategic execution, reimbursement policies, and market receptivity.

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Market Challenges and Opportunities

Challenges:

• Generic Competition: Introduction of generic versions of individual drugs may reduce JALYN's value proposition.
• Pricing Pressures: Insurance companies may favor cost-effective alternatives.
• Physician Adoption: Resistance due to established prescribing habits or skepticism regarding combination therapies.
• Regulatory Risks: Post-market safety concerns could impact sales.

Opportunities:

• Growing BPH Prevalence: An aging population ensures enduring demand.
• Patient Adherence Benefits: Simplified dosing may improve compliance, creating a marketing advantage.
• Combination Therapy Trends: Increasing preference for multi-mechanism treatments.
• Potential for Expanded Indications: Exploring uses beyond BPH, such as male androgen-related conditions, could diversify revenue streams.

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Future Outlook

The financial trajectory for JALYN hinges on its ability to expand market penetration amidst a competitive and cost-sensitive landscape. Strategic focus on prescriber education, demonstrable clinical benefits, and favorable reimbursement policies are crucial. As biosimilar and generic competitors emerge, JALYN's long-term profitability will depend on maintaining differentiated value and innovating with new formulations or indications.

In the broader context, the BPH therapeutics market is poised for modest growth anchored by demographic shifts, but margins are tightening, favoring cost-effective solutions. JALYN's success will be measured by its adaptability and alignment with healthcare system priorities emphasizing efficacy, safety, and affordability.

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Key Takeaways

• The BPH market represents a stable, aging demographic-driven growth opportunity, but faces price sensitivity and fierce competition.
• JALYN's combination therapy offers adherence advantages but must overcome hurdles from generic alternatives and payer constraints.
• Market entry dynamics favor early adoption, physician education, and demonstrated superior outcomes.
• Long-term financial success depends on strategic positioning before biosimilar and generic competitors erode exclusivity.
• Innovation in formulations or expanded indications may bolster JALYN’s market resilience and revenue potential.

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FAQs

1. What is the primary clinical advantage of JALYN over monotherapies?
JALYN combines dutasteride and tamsulosin, providing dual mechanisms—reducing prostate size and relaxing smooth muscles—resulting in potentially faster symptom relief and disease progression prevention compared to monotherapies.

2. How does the patent outlook influence JALYN’s long-term profitability?
Patents protect exclusivity, allowing for premium pricing. As patents expire and generics enter, pricing pressure and market share erosion could significantly impact revenues.

3. What are the main barriers to increased adoption of JALYN?
Physicians’ familiarity with established monotherapies, cost considerations, restricted insurance coverage, and competition from generics are principal barriers.

4. Could JALYN expand into other indications or treatment areas?
Potential exists if clinical studies demonstrate efficacy in related conditions; such expansion could diversify revenue streams and extend product lifespan.

5. How might regulatory changes affect JALYN’s market prospects?
Stricter safety regulations or label restrictions could limit prescribing. Conversely, favorable regulatory updates, such as expanded indications or improved formulations, could enhance its marketability.

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References

[1] Roehrborn, C. (2014). Management of benign prostatic hyperplasia. BMJ, 347, f5257.
[2] MarketsandMarkets. (2022). Benign Prostatic Hyperplasia Therapeutics Market by Type, Distribution Channel, and Region — Global Forecast to 2030.