JANUMET Drug Patent Profile

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

Janumet is a drug marketed by Msd Sub Merck and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty countries.

The generic ingredient in JANUMET 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

Janumet was eligible for patent challenges on October 16, 2010.

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 $2.1bn, indicating a strong incentive for generic entry (peak sales were $2.6bn in 2020).

There have been twenty-eight 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

International Patents:	61
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	20
Drug Prices:	Drug price information for JANUMET
Drug Sales Revenues:	Drug sales revenues for JANUMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUMET
What excipients (inactive ingredients) are in JANUMET?	JANUMET excipients list
DailyMed Link:	JANUMET at DailyMed

See drug prices for JANUMET

See drug sales revenues for JANUMET

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

Constraining patent/regulatory exclusivity:

7,326,708*PED

NDA:

022044

Dosage:

TABLET;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

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 clinical trials

Pharmacology for JANUMET

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

Paragraph IV (Patent) Challenges for JANUMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUMET	Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	022044	5	2010-10-18

US Patents and Regulatory Information for JANUMET

JANUMET is protected by two US patents.

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	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	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	7,326,708*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	8,414,921*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	8,414,921*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	7,326,708*PED				Y
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	7,326,708*PED				Y

Expired US Patents for JANUMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	6,303,661
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,078,381
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	7,459,428
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	6,303,661
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	7,078,381
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	6,890,898
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,459,428

International Patents for JANUMET

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03015775
Japan	2001510442
South Korea	20080022232	CRYSTALLINE MONOHYDRATE OF A PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
European Patent Office	2289513
Argentina	044705	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA -IV
Ecuador	SP056245	SAL DE ÁCIDO FOSFÓRICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV.
European Patent Office	1520582

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C01084705/01	Switzerland		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
1084705	CA 2014 00062	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
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
1506211	CR 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	C300569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1412357	C20070004 00113	Estonia		PRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007

Market Dynamics and Financial Trajectory for JANUMET

Introduction to JANUMET

JANUMET, a combination anti-diabetes drug developed by Merck, contains sitagliptin and metformin, two active ingredients that work together to manage blood sugar levels in patients with Type 2 diabetes. This drug has been a cornerstone in Merck's diabetes franchise, contributing significantly to the company's revenue.

Market Share and Dominance

JANUMET holds a substantial market share in the combination anti-diabetes drugs market. As of the current year, it commands approximately 37.4% of the market share, making it the leading product in its category[1].

Global Prevalence of Diabetes

The increasing prevalence of diabetes globally is a key driver for the demand of anti-diabetes drugs like JANUMET. According to the International Diabetes Federation, the adult diabetes population was approximately 537 million in 2021 and is projected to increase to 643 million by 2030. This rise is largely attributed to factors such as obesity, unhealthy diet, and physical inactivity[1].

Market Size and Growth Projections

The combination anti-diabetes drugs market, led by JANUMET, is expected to experience significant growth. The market size was estimated at USD 1.05 billion in 2023 and is projected to reach USD 1.76 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 10.87% during the forecast period[1].

Financial Performance of JANUMET

Merck's financial reports highlight the robust performance of JANUMET. In 2012, global sales of JANUVIA and JANUMET combined reached $5.7 billion, making it the best-selling product franchise in Merck's history. The sales of these drugs grew by 15% in the United States and by 25% in international markets during the fourth quarter of 2012[3].

Regional Growth

JANUMET has seen significant growth across various regions. In Europe, despite austerity challenges, the drug has maintained robust double-digit growth. In Asia, particularly in Japan, China, and India, JANUMET has shown pronounced growth due to the large diabetic population in these countries. Latin America and the Middle East are also key growth areas for the drug[3].

Impact of Exclusivity Loss

The loss of exclusivity for JANUVIA and JANUMET in certain markets has had a noticeable impact on their sales. In Europe, after JANUVIA lost exclusivity at the end of 2021, patient counts declined significantly, with many patients switching to generic versions. Similarly, JANUMET patient counts fell after it lost exclusivity, with a corresponding rise in patients using generic sitagliptin and metformin combinations[4].

Competitive Landscape

Despite the loss of exclusivity and the rise of generics, JANUMET remains a dominant player in the market. Merck's marketing proficiency, extensive global network, and continued innovation in the diabetes franchise have helped maintain its market position. The "Januvia family" currently holds over a 70% share of the global DPP-4 market, indicating its strong competitive standing[3].

Technological Advancements and Innovations

Merck continues to innovate within its diabetes portfolio. The approval of JANUMET XR, a once-daily formulation of sitagliptin and metformin, and the development of new DPP-4 inhibitors like MK-3102, which is in Phase III trials, are examples of these efforts. These advancements are expected to contribute to the continued growth and dominance of JANUMET in the market[3].

Regulatory Approvals and Expansion

JANUMET has received approvals in all major markets, although there are some African geographies where it is not yet approved. Merck is actively pursuing approvals in these regions to further expand its market reach. The company's focus on emerging markets, including tailored promotional and educational materials for specific populations like Hispanic communities, has been a key strategy in maintaining its market position[3].

Financial Results and Projections

Merck's financial reports reflect the significant contribution of JANUMET to the company's revenue. In the third quarter of 2024, Merck's total worldwide sales were $16.7 billion, with a gross margin of 75.5%. While the loss of exclusivity has impacted sales, the overall financial performance of Merck remains strong, driven by a diverse portfolio that includes other successful products like KEYTRUDA and GARDASIL/GARDASIL 9[5].

Key Takeaways

• Market Dominance: JANUMET holds the highest market share in the combination anti-diabetes drugs market.
• Global Growth: The market is expected to grow significantly due to the increasing prevalence of diabetes.
• Financial Performance: JANUMET has been a major contributor to Merck's revenue, with robust sales across various regions.
• Impact of Exclusivity Loss: The loss of exclusivity has led to a decline in patient counts, but Merck's innovations and global network help maintain its market position.
• Regulatory Approvals: JANUMET has received approvals in major markets and is expanding into emerging markets.

FAQs

What is JANUMET and how does it work?

JANUMET is a combination anti-diabetes drug containing sitagliptin and metformin. It works by inhibiting the DPP-4 enzyme and reducing glucose production in the liver to manage blood sugar levels in Type 2 diabetes patients.

What is the current market share of JANUMET?

JANUMET holds approximately 37.4% of the market share in the combination anti-diabetes drugs market.

How is the global prevalence of diabetes affecting the market for JANUMET?

The increasing prevalence of diabetes, projected to reach 643 million by 2030, is driving the demand for anti-diabetes drugs like JANUMET, contributing to the market's growth.

What is the impact of the loss of exclusivity on JANUMET sales?

The loss of exclusivity has led to a decline in patient counts as many patients switch to generic versions, but Merck's continued innovation and global reach help mitigate this impact.

What are the key regions for JANUMET's growth?

JANUMET has seen significant growth in Europe, Asia (particularly Japan, China, and India), Latin America, and the Middle East.

What are Merck's future plans for the diabetes franchise?

Merck is continuing to innovate with new formulations like JANUMET XR and developing new DPP-4 inhibitors, and is pursuing approvals in emerging markets to expand its reach.

Sources

1. GlobeNewswire: "Combination Anti-Diabetes Drugs Market Size & Share Analysis - Growth Trends & Forecasts (2023 - 2028)"
2. Merck: "Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results"
3. Pharmaceutical Executive: "Brand of the Year: Januvia"
4. Clarivate: "After loss of exclusivity, small-molecule generics bite quick and hard ..."
5. Merck: "Merck Announces Third-Quarter 2024 Financial Results"

Last updated: 2024-12-16