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-nine 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:	44
Patent Applications:	946
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			Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011		DISCN	No	No			Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012		DISCN	No	No			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
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012

International Patents for SUPRENZA

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

Country	Patent Number	Title	Estimated Expiration
Australia	8977698
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)
European Patent Office	2254558	COMPRIMÉS À DISSOLUTION ORALE AYANT UN ASPECT MOUCHETÉ (ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE)
World Intellectual Property Organization (WIPO)	9904758

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

Introduction

Suprenza, a brand name for phentermine hydrochloride, is an orally dissolving tablet used for weight loss. Approved by the FDA in 2011, it has been a part of the weight loss medication market for over a decade. Here, we will delve into the market dynamics and financial trajectory of Suprenza.

Approval and Launch

Suprenza was approved by the FDA on June 13, 2011, and is manufactured by Citius Pharmaceuticals, LLC. The approval marked a new entry in the weight loss medication market, particularly with its unique orally dissolving tablet formulation flavored with sweetened peppermint[2].

Market Segment

Suprenza falls under the prescription segment of the weight loss medication market. This segment has seen significant growth, driven by strong sales of prescription diet medications. The prescription segment accounted for the highest market share in 2020, largely due to medications like Saxenda (liraglutide) and anticipated new launches such as semaglutide by Novo Nordisk A/S[3].

Pharmacokinetics and Efficacy

The pharmacokinetic profile of Suprenza is similar to that of immediate-release phentermine. Studies have shown that Suprenza, whether taken with or without water, produces comparable Tmax (time to maximum concentration) and Cmax (maximum concentration) values to immediate-release phentermine. However, the AUCinf (area under the curve to infinity) values for Suprenza are slightly lower than those of the immediate-release formulation[4].

Market Trends

The weight loss medication market, particularly in Europe, has seen a significant rebound post-COVID-19. The pandemic led to a temporary decline in hospital visits, but the adoption of telemedicine and online pharmacies boosted sales. For instance, Novo Nordisk A/S witnessed a strong sales trend for Saxenda in Europe and the Middle East and Africa (EMEA) region, with a 15% increase over FY 2019 and an 18% growth in FY 2021[3].

Financial Performance

While specific financial data for Suprenza alone is not readily available, the overall prescription weight loss medication market has shown robust growth. The European diet pills market, for example, is projected to grow from $297.1 million in 2021 to $1,411.1 million by 2028, at a CAGR of 24.9%[3].

Competitive Landscape

The weight loss medication market is competitive, with several key players. Suprenza competes with other prescription medications like Saxenda (liraglutide) and Alli (orlistat), an over-the-counter (OTC) drug. The prescription segment, however, is expected to grow at the highest CAGR due to new and anticipated product launches[3].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the weight loss medication market. Initially, there was a decline in prescriptions due to reduced hospital visits. However, the increased use of telemedicine and online pharmacies helped rebound sales. By the end of 2022, the proportion of prescriptions dispensed through telemedicine visits, although declining, remained above pre-pandemic levels[1].

Regional Differences

The market dynamics for weight loss medications vary by region. In Europe and the EMEA region, there has been a strong trend of growth, driven by telemedicine and online pharmacy adoption. In contrast, regions like Latin America face challenges due to socio-economic crises and reduced funding for health services, which can impact the overall market[3][5].

Patient Demographics

The patient demographics for weight loss medications have shifted over the years. For stimulants, which include weight loss medications, there has been an increase in prescriptions dispensed to females, particularly between 2020 and 2021. The age group of 31-40 years has also seen a significant increase in prescriptions, more than tripling since 2012[1].

Future Outlook

The future outlook for Suprenza and the broader weight loss medication market is positive. With new product launches and the continued adoption of telemedicine, the prescription segment is expected to drive growth. The European market, in particular, is projected to see significant expansion, with a CAGR of 24.9% from 2021 to 2028[3].

Key Takeaways

• Market Growth: The prescription weight loss medication market is expected to grow significantly, driven by new product launches and telemedicine adoption.
• Competitive Landscape: Suprenza competes in a competitive market with other prescription and OTC medications.
• COVID-19 Impact: The pandemic initially reduced prescriptions but later boosted sales through telemedicine and online pharmacies.
• Regional Differences: Market dynamics vary by region, with Europe and EMEA showing strong growth.
• Patient Demographics: There has been an increase in prescriptions for females and the 31-40 age group.

FAQs

Q: What is Suprenza, and how is it different from other weight loss medications? A: Suprenza is an orally dissolving tablet formulation of phentermine hydrochloride, approved by the FDA in 2011. It is unique due to its peppermint-flavored, orally dissolving form.

Q: How has the COVID-19 pandemic affected the sales of Suprenza and similar medications? A: The pandemic initially led to a decline in prescriptions but later boosted sales through the increased use of telemedicine and online pharmacies.

Q: What is the projected growth rate for the European diet pills market? A: The European diet pills market is projected to grow at a CAGR of 24.9% from 2021 to 2028.

Q: Which segment of the weight loss medication market is expected to grow the most? A: The prescription segment is expected to grow at the highest CAGR due to new and anticipated product launches.

Q: How do regional differences impact the market dynamics for weight loss medications? A: Regional differences, such as socio-economic crises and funding reductions in Latin America, can significantly impact market dynamics, while regions like Europe show strong growth driven by telemedicine and online pharmacy adoption.

Sources

1. IQVIA Report on Stimulant Trends from 2012 - 2022 - U.S. Department of Justice.
2. Drug Approval Package: Suprenza (phentermine hydrochloride) - FDA.
3. Europe Diet Pills Market Size, Share | Growth [2021-2028] - Fortune Business Insights.
4. APPLICATION NUMBER: 202088Orig1s000 OTHER REVIEW(S) - FDA.
5. Global State of Harm Reduction 2020 - Harm Reduction International.