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JANUMET XR Drug Patent Profile

Which patents cover Janumet Xr, and when can generic versions of Janumet Xr launch?

Janumet Xr is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has fifty-two patent family members in forty countries.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Janumet Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $734mm indicating the motivation for generic entry (peak sales were $1.1bn in 2018).

There have been twenty-six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (metformin hydrochloride; sitagliptin phosphate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for JANUMET XR

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	20
Patent Applications:	48
Drug Prices:	Drug price information for JANUMET XR
Drug Sales Revenues:	Drug sales revenues for JANUMET XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUMET XR
What excipients (inactive ingredients) are in JANUMET XR?	JANUMET XR excipients list
DailyMed Link:	JANUMET XR at DailyMed

See drug prices for JANUMET XR

See drug sales revenues for JANUMET XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JANUMET XR

Constraining patent/regulatory exclusivity:

7,326,708*PED

NDA:

202270

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JANUMET XR

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

Sponsor	Phase
Galenicum Health	Phase 1
Genuine Research Center, Egypt	Phase 1
Eva Pharma	Phase 1

See all JANUMET XR clinical trials

Pharmacology for JANUMET XR

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Paragraph IV (Patent) Challenges for JANUMET XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUMET XR	Extended-release Tablets	metformin hydrochloride; sitagliptin phosphate	100 mg/1000 mg	202270	1	2012-10-22
JANUMET XR	Extended-release Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	202270	1	2012-03-16

US Patents and Regulatory Information for JANUMET XR

JANUMET XR is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,326,708.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No

Expired US Patents for JANUMET XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012	6,890,898
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012	6,340,475
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012	6,303,661
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012	7,078,381
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012	6,635,280
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012	6,890,898

International Patents for JANUMET XR

See the table below for patents covering JANUMET XR around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	139595	PHOSPHORIC ACID SALT OF A DIPEPTIDYL - IV INHIBITOR
Japan	2001510442
Germany	60236767
Canada	2364845	PROLONGATION DE LA DUREE DE LIBERATION DE MEDICAMENT DANS L'ESTOMAC AU COURS DU MODE D'ALIMENTATION (EXTENDING THE DURATION OF DRUG RELEASE WITHIN THE STOMACH DURING THE FED MODE)
Bulgaria	108493
Netherlands	300287

Supplementary Protection Certificates for JANUMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1412357	42/2007	Austria		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
1412357	122008000046	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
2498758	PA2020003,C2498758	Lithuania		PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116

JANUMET XR Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for JANUMET XR

Introduction

JANUMET XR, a once-daily extended-release formulation of sitagliptin and metformin HCl, has been a significant player in the diabetes treatment market since its FDA approval in 2012. Here, we delve into the market dynamics and financial trajectory of this drug.

FDA Approval and Clinical Significance

JANUMET XR was approved by the FDA based on a clinical bioequivalence study that demonstrated its equivalence to the co-administration of sitagliptin and metformin HCl extended-release. This approval marked a significant milestone, offering patients with type 2 diabetes a convenient once-daily treatment option to help control blood sugar levels[4].

Market Position and Competition

JANUMET XR is part of the "Januvia family," which dominates the global DPP-4 inhibitor market. The "Januvia family" holds over 70% of the global DPP-4 market, with Januvia and Janumet being the leading products. This strong market position is attributed to the drugs' efficacy and the extensive global reach of Merck[3].

Sales Performance

In 2022, Merck recorded $1.7 billion in revenue from Janumet, which includes Janumet XR. The sales of Janumet XR have been driven by increased demand, partly due to its expanded approval for heart failure and other indications. For instance, in the US, Q4 2022 sales of Janumet increased by 51% to $363.1 million, primarily driven by increased demand and higher royalties from Boehringer Ingelheim[1].

Global Reach and Emerging Markets

Merck has successfully expanded the reach of Janumet XR into various global markets. The drug has received approvals in all major markets, with significant growth observed in regions such as Japan, Latin America, and the Middle East. Despite challenges in certain African geographies, Merck continues to pursue approvals and market penetration in these areas[3].

Pricing Strategy

JANUMET XR is priced comparably to Januvia and Janumet on a per-daily-dose basis, making it an attractive option for patients and healthcare providers. This pricing strategy has helped maintain market share and drive sales[4].

Financial Impact on Merck

The financial performance of Janumet XR is closely tied to Merck's overall pharmaceutical sales. In 2023, Merck's pharmaceutical sales, which include Januvia and Janumet, were $53.583 billion, a 3% increase from 2022. However, the sales of Januvia/Janumet specifically decreased by 25% to $3.366 billion in 2023 compared to 2022, largely due to competitive pressures and changes in market dynamics[2].

Competitive Landscape

The diabetes market is highly competitive, with the entry of insulin biosimilars and other DPP-4 inhibitors. For example, the introduction of biosimilars like Sanofi’s Trurapi and Biocon Biologics’ Kirsty has impacted the sales of branded insulin products, including Novo Nordisk's NovoRapid. However, Janumet XR's strong brand presence and expanded indications have helped it maintain a competitive edge[1].

Future Growth Prospects

Despite the competitive landscape, analysts remain bullish on the Januvia franchise, including Janumet XR. The drug's potential cardiovascular benefits, as suggested by post-hoc analyses and meta-analyses, could further enhance its market position. Additionally, Merck's ongoing efforts to expand into emerging markets and secure new approvals will likely drive future growth[3].

Regulatory and Approval Updates

Recent approvals for Janumet XR in pediatric indications for type 2 diabetes and in adults with chronic kidney disease have bolstered its market potential. These approvals, along with the drug's existing heart failure indications, are expected to increase demand and sales in the coming years[1].

Key Takeaways

• Strong Market Position: Janumet XR dominates the DPP-4 inhibitor market with over 70% global share.
• Global Reach: Approved in all major markets with significant growth in Japan, Latin America, and the Middle East.
• Pricing Strategy: Priced comparably to Januvia and Janumet, making it an attractive option.
• Financial Performance: Contributed significantly to Merck's pharmaceutical sales, despite a recent decline.
• Competitive Edge: Maintains market share due to expanded indications and strong brand presence.
• Future Growth: Expected to grow with new approvals and potential cardiovascular benefits.

FAQs

What is JANUMET XR and how does it differ from other diabetes treatments?

JANUMET XR is a once-daily extended-release formulation of sitagliptin and metformin HCl, approved for the treatment of type 2 diabetes. It differs from other treatments by offering a convenient once-daily dosing regimen.

How has the sales performance of JANUMET XR been in recent years?

In 2022, Janumet, including Janumet XR, recorded $1.7 billion in revenue, with a significant increase in Q4 sales in the US. However, in 2023, the sales of Januvia/Janumet decreased by 25% due to competitive pressures.

What are the key factors driving the demand for JANUMET XR?

The demand for Janumet XR is driven by its expanded approvals, including heart failure and other indications, as well as its convenience and efficacy.

How does JANUMET XR compare to other DPP-4 inhibitors in the market?

JANUMET XR holds a dominant position in the DPP-4 inhibitor market, with over 70% global share, due to its strong brand presence and extensive global reach.

What are the future growth prospects for JANUMET XR?

The future growth of Janumet XR is expected to be driven by new approvals, potential cardiovascular benefits, and continued expansion into emerging markets.

Sources

1. Xtalks: Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics
2. Merck: Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results
3. Pharmaceutical Executive: Brand of the Year: Januvia
4. Merck: FDA Approves JANUMET® XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes
5. Merck: Condensed Consolidated Statement of Cash Flows (Unaudited)