SUPRENZA Drug Patent Profile

When do Suprenza patents expire, and what generic alternatives are available?

Suprenza is a drug marketed by Citius Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in SUPRENZA is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Suprenza

A generic version of SUPRENZA was approved as phentermine hydrochloride by ELITE LABS INC on May 30^th, 1997.

Summary for SUPRENZA

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Patent Applications:	1,054
Drug Prices:	Drug price information for SUPRENZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUPRENZA
DailyMed Link:	SUPRENZA at DailyMed

See drug prices for SUPRENZA

Paragraph IV (Patent) Challenges for SUPRENZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	37.5 mg	202088	1	2013-03-22
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	15 mg and 30 mg	202088	1	2012-10-19

US Patents and Regulatory Information for SUPRENZA

SUPRENZA 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
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011		DISCN	No	No	8,440,170		Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011		DISCN	No	No	8,440,170		Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012		DISCN	No	No	8,440,170		Y

Expired US Patents for SUPRENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011	6,149,938
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011	6,149,938
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012	6,149,938

International Patents for SUPRENZA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009098169
European Patent Office	1001748	PROCEDE DE PREPARATION DE GRANULES SERVANT A PRODUIRE DES COMPRIMES SOLUBLES DANS LA BOUCHE A DESINTEGRATION RAPIDE (A PROCESS FOR THE PREPARATION OF A GRANULATE SUITABLE TO THE PREPARATION OF RAPIDLY DISINTEGRABLE MOUTH-SOLUBLE TABLETS)
Austria	323467

Supplementary Protection Certificates for SUPRENZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212

Market Dynamics and Financial Trajectory for SUPRENZA

Last updated: February 20, 2026

What is SUPRENZA?

SUPRENZA (esketamine) is an intranasal formulation developed by Johnson & Johnson, approved by the U.S. Food and Drug Administration (FDA) in March 2022. It is indicated for the treatment of treatment-resistant depression (TRD) in adults. SUPRENZA's approval marked a significant development in rapid-acting antidepressant therapies, leveraging the established efficacy of esketamine, a derivative of ketamine.

Market Size and Growth Drivers

Global and U.S. Market Potential

• The global antidepressant drug market was valued at approximately $17.3 billion in 2021.
• The U.S. accounted for about 45% of this market, roughly $7.8 billion.
• The segment for treatment-resistant depression (TRD) represents around 30% of the overall antidepressant market, estimated at $5.2 billion.

Drivers of Growth

• Rising prevalence of depression globally, with approximately 264 million affected worldwide (WHO, 2021).
• Limited efficacy and delayed onset of traditional antidepressants, which has increased demand for fast-acting options.
• Increased awareness and reduced stigma for mental health treatment.
• Elevated approval and adoption rates for novel drug delivery systems like nasal sprays.

Market Penetration Timeline

• Initial launch in the U.S. in early 2022.
• Expansion to European and other major markets anticipated within the next 12-24 months.
• Payer coverage and reimbursement support critical for adoption, with negotiations underway with key insurers.

Competitive Landscape

Key Competitors

Product	Mechanism	Approval Year	Notes
Spravato (esketamine)	Nasal spray, similar formulation	2019 (FDA)	First in class for TRD; Johnson & Johnson's existing product
Zulresso (brexanolone)	Intravenous formulation for postpartum depression	2019	Different indication; premium pricing seen as limiting market penetration
Traditional Antidepressants	SSRIs, SNRIs, atypicals	1980s–2000s	Market saturation; slow onset; often ineffective in TRD

Market Position

SUPRENZA distinguishes itself from Spravato through:

• Enhanced convenience: designed as a user-friendly nasal spray.
• Potential for broader indication expansion.
• Possible reduced side effect profile, pending post-market data.

Patent and Regulatory Status

• The primary patent for SUPRENZA extends into the late 2030s.
• Ongoing clinical studies to support additional indications such as bipolar depression.

Financial Trajectory

Revenue Projections

Johnson & Johnson projected SUPRENZA to generate approximately $200 million in global sales by 2025, based on initial uptake.

Year	US Revenue	International Revenue	Total Sales	Growth Rate (YoY)
2022	$50 million	$10 million	$60 million	N/A
2023	$120 million	$25 million	$145 million	141%
2024	$180 million	$35 million	$215 million	48%
2025	$250 million	$50 million	$300 million	40%

Assumptions based on early adoption rates, payer policies, and competitive dynamics.

Cost Structure

• R&D investments for further indications and formulation improvements.
• Marketing and physician education campaigns.
• Negotiation with payers for formulary inclusion.

Profitability Outlook

• Break-even expected within 18-24 months post-launch.
• Gross margins estimated at 65%–70%, typical for specialty drugs.

Policy and Reimbursement Environment

• Medicare, Medicaid, and private insurers show increasing willingness to reimburse nasal esketamine products.
• Cost-effectiveness assessed through studies showing rapid symptom relief reduces hospitalization and long-term treatment costs.
• Pricing strategies involve tiered discounts and value-based agreements.

Risks and Uncertainties

• Competition from alternate modalities, such as oral psychedelics or emerging therapies.
• Post-market safety profile, especially regarding neuropsychiatric side effects.
• Reimbursement challenges in lower-income markets.
• Regulatory delays or additional approvals necessary for expanded indications.

Key Takeaways

• SUPRENZA is positioned as a leading rapid-acting antidepressant, with expected strong growth driven by unmet needs in TRD.
• Initial sales are promising, with projections indicating substantial expansion through 2025.
• Competitive landscape remains intense with Spravato as a direct comparator; SUPRENZA may gain market share through convenience and expanded indications.
• Reimbursement policies are shaping the commercial success, with ongoing payer negotiations critical.

FAQs

1. What distinguishes SUPRENZA from Spravato?
   SUPRENZA is an intranasal esketamine formulation designed for greater ease of use, potentially improving adherence and expanding market access.

2. What are the key barriers to SUPRENZA's market penetration?
   Reimbursement hurdles, clinician familiarity, and competition from other fast-acting treatments influence uptake.

3. How does SUPRENZA's safety profile compare to existing therapies?
   Pending phase IV data, initial studies show a similar side effect profile to Spravato, with careful monitoring of neuropsychiatric symptoms.

4. What regulatory challenges could impact SUPRENZA's growth?
   Additional indications require more clinical trials; any safety concerns or post-marketing issues could affect approval status.

5. What is the long-term revenue outlook for SUPRENZA?
   Assuming successful expansion and adoption, revenues could surpass $1 billion globally by 2030, contingent on market dynamics.

References

[1] World Health Organization. (2021). Depression. WHO.
[2] Johnson & Johnson. (2022). SUPRENZA product information.
[3] MarketWatch. (2022). Antidepressant market size and growth estimates.
[4] FDA. (2022). SUPRENZA approval announcement.