PRISTIQ Drug Patent Profile

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

Pristiq is a drug marketed by Pf Prism Cv and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-two patent family members in sixteen countries.

The generic ingredient in PRISTIQ is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pristiq

A generic version of PRISTIQ was approved as desvenlafaxine succinate by ALEMBIC on June 29^th, 2015.

Summary for PRISTIQ

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	23
Patent Applications:	50
Drug Prices:	Drug price information for PRISTIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRISTIQ
What excipients (inactive ingredients) are in PRISTIQ?	PRISTIQ excipients list
DailyMed Link:	PRISTIQ at DailyMed

See drug prices for PRISTIQ

See drug sales revenues for PRISTIQ

Recent Clinical Trials for PRISTIQ

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

Sponsor	Phase
David Steffens	Phase 4
National Institute of Mental Health (NIMH)	Phase 4
Seoul National University Bundang Hospital	Phase 4

See all PRISTIQ clinical trials

Pharmacology for PRISTIQ

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for PRISTIQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	25 mg	021992	1	2015-05-08
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	50 mg and 100 mg	021992	12	2012-02-29

US Patents and Regulatory Information for PRISTIQ

PRISTIQ 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
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014	AB	RX	Yes	No	8,269,040			Y
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	AB	RX	Yes	No	8,269,040			Y
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	AB	RX	Yes	Yes	8,269,040			Y

Expired US Patents for PRISTIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	7,291,347
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014	6,673,838
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	6,673,838
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	7,291,347
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	6,673,838

International Patents for PRISTIQ

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1165487
Portugal	1466889
European Patent Office	1466889	O-Desméthylvenlafaxine succinate (O-Desmethylvenlafaxine succinate)
Australia	2002250058
Poland	350924
Germany	60221642

PRISTIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PRISTIQ (Desvenlafaxine)

Introduction

PRISTIQ, or desvenlafaxine, is a serotonin and norepinephrine reuptake inhibitor (SNRI) used primarily for the treatment of major depressive disorder (MDD) in adults. Here, we will delve into the market dynamics and financial trajectory of this drug.

Clinical Efficacy and Market Position

PRISTIQ has been proven effective in several clinical studies, demonstrating its ability to improve depression symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D)[1][3].

• The drug has shown significant efficacy in reducing depression scores compared to placebo in both short-term and long-term studies.
• Its effectiveness in managing depression and reducing the risk of relapse has solidified its position as a treatment option for MDD.

Market Launch and Sales Performance

PRISTIQ was introduced to the market by Pfizer, and it quickly gained traction due to its efficacy and the growing demand for antidepressants.

• By the time generic versions were introduced, PRISTIQ had established a strong market presence, with annual sales of approximately $883 million in the U.S. as of December 2016[4].

Generic Competition

The launch of generic desvenlafaxine extended-release tablets by Teva Pharmaceutical Industries in 2017 marked a significant shift in the market dynamics.

• Generic competition typically leads to price erosion, which can impact the sales and revenue of the branded product. However, Teva's entry also expanded the availability of desvenlafaxine, potentially increasing overall market size[4].

Financial Performance of Pfizer

During its peak, PRISTIQ contributed significantly to Pfizer's revenue.

• In the third quarter of 2013, PRISTIQ was among the drugs that performed strongly for Pfizer, helping offset declines in other areas of the company's portfolio[5].

Revenue and Market Share

Before the introduction of generics, PRISTIQ generated substantial revenue for Pfizer.

• The drug's annual sales of $883 million in the U.S. alone underscored its commercial success. However, the entry of generics led to a decline in branded sales, as is typical in the pharmaceutical industry[4].

Impact of Generic Entry on Revenue

The launch of generic desvenlafaxine led to a reduction in Pfizer's revenue from PRISTIQ.

• Generic competition often results in significant price reductions, making the generic version more attractive to patients and payers. This shift can lead to a substantial decline in the sales of the branded product[4].

Pfizer's Adjusted Financials

Pfizer's financial reports reflect the impact of generic competition on PRISTIQ sales.

• While PRISTIQ was a strong performer in 2013, subsequent years saw a decline in revenue due to generic competition. Pfizer's overall revenue and adjusted income were affected, though the company managed to maintain profitability through a diversified portfolio[5].

Market Dynamics Post-Generic Entry

Post-generic entry, the market for desvenlafaxine has become more competitive.

• Teva's generic version, along with other potential generic entrants, has increased the availability and affordability of desvenlafaxine. This competition has driven down prices, making the treatment more accessible but reducing the revenue generated by the branded product[4].

Consumer and Payer Impact

The availability of generic desvenlafaxine has benefited consumers and payers.

• Lower prices due to generic competition have made the treatment more affordable, increasing access to effective antidepressant therapy. This shift aligns with broader healthcare trends emphasizing cost-effectiveness and patient access[4].

Future Outlook

The future outlook for desvenlafaxine, both branded and generic, is influenced by several factors:

• Market Saturation: The antidepressant market is highly competitive, with multiple treatment options available. Desvenlafaxine will need to compete with other SNRIs and SSRIs.
• Innovation: Continuous innovation in antidepressant therapies could impact the market share of desvenlafaxine.
• Regulatory Environment: Changes in regulatory policies and reimbursement strategies can affect the drug's market dynamics.

Key Takeaways

• PRISTIQ has been clinically proven to be effective in treating major depressive disorder.
• The drug had significant commercial success before the introduction of generic versions.
• Generic competition has led to a decline in branded sales but increased overall market accessibility.
• The future outlook is influenced by market competition, innovation, and regulatory changes.

FAQs

Q: What is PRISTIQ used for? A: PRISTIQ (desvenlafaxine) is used for the treatment of major depressive disorder (MDD) in adults.

Q: How effective is PRISTIQ in treating depression? A: PRISTIQ has been shown to be effective in reducing depression symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D) in several clinical studies[1][3].

Q: What was the impact of generic entry on PRISTIQ sales? A: The introduction of generic desvenlafaxine led to a significant decline in PRISTIQ's branded sales due to price competition[4].

Q: Who launched the generic version of PRISTIQ? A: Teva Pharmaceutical Industries launched the generic version of PRISTIQ in the United States in 2017[4].

Q: How has the availability of generics affected consumers and payers? A: The availability of generic desvenlafaxine has made the treatment more affordable, increasing access to effective antidepressant therapy for consumers and reducing costs for payers[4].

Cited Sources

1. Pfizer Announces Top-Line Efficacy Results From A Phase 4 Study Of PRISTIQ® (desvenlafaxine) For The Treatment Of Major Depressive Disorder (MDD) In Adults - Pfizer.
2. Viatris Reports Strong Fourth Quarter and Full Year 2022 Financial Results - Viatris.
3. Pristiq: Side effects, dosage, withdrawal, cost, and more - Medical News Today.
4. Teva Announces Launch of Generic Pristiq® in the United States - Teva Pharmaceutical Industries.
5. Pfizer Reports Third Quarter 2013 Results - Pfizer.