PEXEVA Drug Patent Profile

When do Pexeva patents expire, and when can generic versions of Pexeva launch?

Pexeva is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in twenty-five countries.

The generic ingredient in PEXEVA is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pexeva

A generic version of PEXEVA was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20^th, 2017.

Summary for PEXEVA

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	1
Patent Applications:	184
Drug Prices:	Drug price information for PEXEVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEXEVA
What excipients (inactive ingredients) are in PEXEVA?	PEXEVA excipients list
DailyMed Link:	PEXEVA at DailyMed

See drug prices for PEXEVA

See drug sales revenues for PEXEVA

Recent Clinical Trials for PEXEVA

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

Sponsor	Phase
Central Michigan University	N/A
Sheppard Pratt Health System	N/A

See all PEXEVA clinical trials

US Patents and Regulatory Information for PEXEVA

PEXEVA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003		DISCN	Yes	No	7,598,271			Y
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003		DISCN	Yes	No	7,598,271			Y
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-002	Jul 3, 2003		DISCN	Yes	No	7,598,271			Y
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003		DISCN	Yes	No	7,598,271			Y

Expired US Patents for PEXEVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-002	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-002	Jul 3, 2003	6,703,408
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003	6,703,408
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003	6,703,408

International Patents for PEXEVA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100543614
Hong Kong	1027352
New Zealand	532432	N-formyl paroxetine compounds and their use in a synthetic route for obtaining paroxetine
Germany	60202381
Bulgaria	64315
Slovakia	283394

Market Dynamics and Financial Trajectory for PEXEVA (Paroxetine Mesylate)

Introduction

PEXEVA, a brand name for paroxetine mesylate, is a selective serotonin reuptake inhibitor (SSRI) widely used for treating various psychiatric disorders, including major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder (PD), and generalized anxiety disorder (GAD). Here, we delve into the market dynamics and financial trajectory of PEXEVA.

Approval and Initial Market Presence

PEXEVA was approved for medical use in the United States in 1992, initially marketed by GlaxoSmithKline (GSK)[1][2][3].

• Its introduction marked a significant milestone in the treatment of psychiatric disorders, leveraging the efficacy of SSRIs.

Market Performance

Prescription Volume

By 2006, paroxetine was the fifth-most prescribed antidepressant in the U.S. retail market, with over 19.7 million prescriptions. This number slightly decreased to 18.1 million in 2007 but still maintained its position as the fifth-most prescribed antidepressant[1].

• In 2022, paroxetine was the 92nd most commonly prescribed medication in the United States, with more than 7 million prescriptions, indicating a sustained market presence[1].

Sales Revenue

In 2007, paroxetine was ranked 94th on the list of bestselling drugs, with over $1 billion in sales. This figure underscores its commercial success and market demand[1].

Pricing and Affordability

Current Pricing

The cost for PEXEVA mesylate 10 mg oral tablets is around $362 for a supply of 30 tablets, varying by pharmacy. This pricing makes it a relatively expensive medication, especially for long-term treatment[5].

Generic Availability

Despite its widespread use, there is currently no therapeutically equivalent generic version of PEXEVA available in the United States. This lack of generic competition contributes to its higher pricing and maintains the brand's market share[4].

Legal and Regulatory Challenges

Marketing Controversies

GSK faced significant legal and regulatory challenges related to the marketing of paroxetine. These included off-label marketing for children, suppression of negative research results, and failure to warn consumers about substantial withdrawal effects. In 2012, GSK was fined $3 billion by the U.S. Department of Justice for these practices[1].

Anticompetitive Practices

In 2016, the UK Competition and Markets Authority imposed record fines on GSK and other companies for anticompetitive agreements that delayed the market entry of generic versions of paroxetine. This led to substantial financial penalties and potential damages claims from public health services[1].

Economic Impact

Cost to Healthcare Systems

The absence of generic versions and the anticompetitive practices have resulted in higher costs for healthcare systems. For instance, in the UK, public health services were overcharged due to the delayed entry of generics, which are over 70% less expensive than the brand-name drug[1].

Patient Access

The high cost and lack of generic alternatives can limit patient access to this medication. This is particularly concerning for chronic conditions that require long-term treatment, such as MDD and OCD.

Clinical Efficacy and Market Demand

Indications and Usage

PEXEVA is indicated for several psychiatric disorders, including MDD, OCD, PD, and GAD. Its efficacy in these areas has been established through numerous clinical trials, contributing to its sustained market demand[2][3].

Side Effects and Warnings

Despite its efficacy, PEXEVA comes with significant warnings, including increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, serotonin syndrome, and other potential side effects. These factors can influence prescribing decisions but have not significantly diminished its market presence[2][3].

Future Outlook

Patent Expiration

The patent for PEXEVA is set to expire on May 4, 2025. This expiration could lead to the entry of generic versions, potentially reducing the cost and increasing accessibility for patients[4].

Market Competition

The entry of generics post-patent expiration is expected to increase market competition, which could impact the pricing and market share of the brand-name drug. However, the lack of current generic alternatives means that PEXEVA will likely maintain its market position until then.

Key Takeaways

• Sustained Market Presence: PEXEVA has maintained a significant market presence since its approval in 1992.
• High Prescription Volume: It remains one of the most prescribed antidepressants in the U.S.
• Legal and Regulatory Challenges: GSK has faced substantial fines and legal issues related to the marketing and anticompetitive practices of paroxetine.
• Economic Impact: The absence of generics and anticompetitive practices have led to higher costs for healthcare systems.
• Clinical Efficacy: PEXEVA is effective in treating various psychiatric disorders, contributing to its market demand.
• Future Outlook: The patent expiration in 2025 could lead to increased competition and reduced costs.

FAQs

Q: What is PEXEVA used for?

A: PEXEVA is used for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder (PD), and generalized anxiety disorder (GAD)[2][3].

Q: Is there a generic version of PEXEVA available?

A: No, there is currently no therapeutically equivalent generic version of PEXEVA available in the United States[4].

Q: What are the significant side effects of PEXEVA?

A: PEXEVA carries warnings for increased risk of suicidal thoughts and behaviors, serotonin syndrome, and other potential side effects such as seizures and angle-closure glaucoma[2][3].

Q: Why is PEXEVA expensive?

A: The lack of generic competition and anticompetitive practices have contributed to the higher pricing of PEXEVA[1][4].

Q: What is the future outlook for PEXEVA after patent expiration?

A: The patent expiration in 2025 is expected to lead to the entry of generic versions, potentially reducing the cost and increasing accessibility for patients[4].

Sources

1. Wikipedia: Paroxetine
2. Drugs.com: Pexeva: Package Insert / Prescribing Information
3. FDA: Prescribing Information PEXEVA Brand of (paroxetine mesylate) tablets
4. Drugs.com: Generic Pexeva Availability
5. Drugs.com: Pexeva Prices, Coupons, Copay Cards & Patient Assistance