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. Six 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 ENDO OPERATIONS on February 26^th, 2014.

Summary for JALYN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	11
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

Pharmacology for JALYN

Drug Class	5-alpha Reductase Inhibitor alpha-Adrenergic Blocker
Mechanism of Action	5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists

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	Yes

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	5,565,467
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	5,846,976
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	5,998,427

International Patents for JALYN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0719277	ANDROSTENONES (ANDROSTENONES)
Greece	3032198
Singapore	52650	Androstenone derivative

Supplementary Protection Certificates for JALYN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0719278	03C0030	France		PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
0719278	23/2003	Austria		PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
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

Market Dynamics and Financial Trajectory for Jalyn

Introduction to Jalyn

Jalyn, a fixed-dose combination of dutasteride and tamsulosin, is a significant player in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Approved by the FDA in 2010, Jalyn offers a dual mechanism of action to improve symptoms and shrink the prostate over time[4].

Market Growth and Forecast

The benign prostatic hyperplasia treatment market, within which Jalyn operates, is experiencing robust growth. The global BPH treatment market is anticipated to grow from $5.87 billion in 2024 to $9.71 billion by 2030, at a Compound Annual Growth Rate (CAGR) of 5.3%[3].

Patent Expiry and Generic Competition

A critical factor influencing Jalyn's market dynamics is the expiry of patents for key BPH medications. The patents for drugs like Avodart, Cialis, and Jalyn itself have expired, paving the way for generic versions. This shift has significantly impacted the market, as generic versions of Jalyn (dutasteride/tamsulosin) are now available at substantially lower prices. For instance, a generic version of Jalyn can cost as low as $67.59 for a 30-capsule supply, compared to the branded version which can cost around $722 for the same quantity[2][3].

Pricing and Accessibility

The pricing of Jalyn and its generic counterparts plays a crucial role in its market trajectory. The branded version of Jalyn remains expensive, with a 30-capsule supply costing approximately $722. However, the availability of generic versions at significantly lower prices (around $67.59 for 30 capsules) has increased accessibility and potentially boosted sales volumes despite lower revenue per unit[2].

Product Pipeline and Innovation

The BPH treatment market is characterized by a strong product pipeline, driven by the demand for more effective treatment options. The combination therapy offered by Jalyn, which includes both a 5-alpha reductase inhibitor (dutasteride) and an alpha blocker (tamsulosin), has been shown to improve symptoms more effectively than either medication alone. This dual-action approach has contributed to its market success and continues to drive innovation in BPH treatment[4].

Regional Market Performance

The market performance of Jalyn varies across different regions. North America, particularly the United States, holds a significant share of the BPH treatment market. The US market for BPH treatments, including Jalyn, is well-established, with a strong presence of both branded and generic versions. Other key regions include Europe, Asia-Pacific, and South America, each with their own growth trajectories and market dynamics[3].

Financial Impact of Generic Competition

The introduction of generic versions of Jalyn has had a mixed financial impact. While the lower prices of generic versions may reduce revenue per unit, they also increase accessibility and potentially lead to higher sales volumes. For example, the cost of a generic alpha blocker can be as low as $8 per month, compared to nearly $100 per month for a branded product. This shift can lead to increased market penetration and overall sales, albeit at lower profit margins[1].

Clinical Efficacy and Safety

Jalyn's clinical efficacy and safety have been well-documented. The Combination with Alpha-Blocker Therapy (CombAT) trial demonstrated that co-administration of dutasteride and tamsulosin significantly improved BPH symptoms compared to either medication alone. However, common adverse reactions include impotence, decreased libido, breast disorders, ejaculation disorders, and dizziness[5].

Market Opportunities and Challenges

The BPH treatment market presents several opportunities for Jalyn and its generic counterparts. The rising prevalence of BPH and advancements in minimally invasive treatments are driving strong demand. However, the market also faces challenges such as intense competition from other generic and branded products, and the need for continuous innovation to maintain market share[3].

Key Takeaways

• Market Growth: The global BPH treatment market is expected to grow at a CAGR of 5.3% from 2024 to 2030.
• Generic Competition: The expiry of patents for key BPH medications has led to the availability of generic versions of Jalyn, significantly impacting pricing and accessibility.
• Regional Performance: North America, particularly the US, is a key market for Jalyn, with other regions also showing growth potential.
• Financial Impact: Generic competition may reduce revenue per unit but can increase overall sales volumes.
• Clinical Efficacy: Jalyn has been shown to improve BPH symptoms more effectively than either medication alone.

FAQs

1. What is Jalyn used for? Jalyn is used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, improving symptoms and shrinking the prostate over time[4].

2. How much does Jalyn cost? The branded version of Jalyn can cost around $722 for a 30-capsule supply, while generic versions are available for as low as $67.59 for the same quantity[2].

3. What are the common side effects of Jalyn? Common adverse reactions include impotence, decreased libido, breast disorders, ejaculation disorders, and dizziness[5].

4. How does the market for BPH treatments look in the future? The global BPH treatment market is anticipated to grow from $5.87 billion in 2024 to $9.71 billion by 2030, at a CAGR of 5.3%[3].

5. What impact does generic competition have on Jalyn's market performance? Generic competition reduces the revenue per unit but can increase overall sales volumes due to higher accessibility and lower prices[1][3].

Sources

1. MarketsandMarkets - Benign Prostatic Hyperplasia Treatment Market
2. Drugs.com - Jalyn Prices, Coupons, Copay Cards & Patient Assistance
3. Exactitude Consultancy - Benign Prostatic Hyperplasia Treatment Market is growing at a CAGR of 5.3% from 2024 to 2030
4. GSK - FDA approves Jalyn™, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate
5. FDA - JALYN (dutasteride and tamsulosin hydrochloride) Label