JUVISYNC Drug Patent Profile

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

Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in JUVISYNC is simvastatin; sitagliptin phosphate. There are forty drug master file entries for this compound. Additional details are available on the simvastatin; sitagliptin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Juvisync

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 11, 2026. This may change due to patent challenges or generic licensing.

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.

Indicators of Generic Entry

Summary for JUVISYNC

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JUVISYNC
DailyMed Link:	JUVISYNC at DailyMed

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

Constraining patent/regulatory exclusivity:

7,326,708*PED

NDA:

202343

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.

Paragraph IV (Patent) Challenges for JUVISYNC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	202343	1	2012-11-06
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	100 mg/20 mg	202343	1	2012-06-25
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	100 mg/10 mg and 100 mg/40 mg	202343	1	2012-06-19

US Patents and Regulatory Information for JUVISYNC

JUVISYNC is protected by one 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
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012		DISCN	Yes	No	7,326,708*PED				Y

Expired US Patents for JUVISYNC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	7,459,428
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011	8,168,637
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011	6,890,898
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	6,890,898

International Patents for JUVISYNC

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20070534
Japan	2002501889
Denmark	1654263
Poland	1654263

Supplementary Protection Certificates for JUVISYNC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	0790041-8	Sweden		PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
1412357	C 2007 091	Romania		PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 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

JUVISYNC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Juvisync

Introduction

Juvisync, a combination drug developed by Merck, was designed to treat two prevalent conditions: Type 2 diabetes and high cholesterol. This article delves into the market dynamics and financial trajectory of Juvisync, highlighting its launch, marketing strategies, and the reasons behind its eventual discontinuation.

Background and Approval

Juvisync was approved by the FDA in October 2011, combining the DPP-4 inhibitor Januvia (sitagliptin) with the statin Zocor (simvastatin). This combination was aimed at addressing the increased risk of heart disease in diabetic patients, a recommendation supported by the American Diabetes Association[1][3][4].

Marketing Strategy

Merck's marketing strategy for Juvisync was multifaceted. It began with healthcare provider (HCP)-oriented marketing, including educational materials, journals, continuing medical education (CME) programs, and meetings. This was followed by direct-to-consumer (DTC) marketing through print, digital, and other channels, emphasizing Juvisync as part of a comprehensive treatment program that included diet, exercise, and meal modification[4].

Target Market

The target market for Juvisync included Type 2 diabetes patients who also had high cholesterol. This combination is common and can lead to increased risks of cardiovascular disease, renal disease, or blindness if not properly managed. The drug was positioned as an "intelligent choice" for patients with both conditions, offering the convenience of a single pill[4].

Financial Expectations

Despite its theoretical advantages, Juvisync failed to meet financial expectations. Merck had anticipated that up to 8 million Type 2 diabetes patients could benefit from a statin but were not taking one. However, the drug did not gain significant traction in the market[1].

Sales Performance

Juvisync's sales performance was disappointing. In contrast to other products in the Januvia franchise, such as Janumet (a combination of Januvia and metformin), which generated over $1.6 billion in sales for Merck in 2012, Juvisync did not achieve similar success. This led Merck to announce the cessation of Juvisync's distribution in the U.S. and Puerto Rico in 2013, citing business reasons rather than any concerns about the drug's efficacy or safety[1][3].

Competitive Landscape

The diabetes and cholesterol management markets are highly competitive. While Juvisync was the first combination drug to treat both conditions, it faced competition from other DPP-4 inhibitors like Onglyza and Tradjenta, which did not have a statin component but were still popular among patients and healthcare providers. The lack of a compelling differentiation and the failure to capture a significant market share contributed to Juvisync's poor performance[4].

Global Market Dynamics

Merck's success with Januvia and Janumet in global markets, particularly in Asia, Europe, and Latin America, did not translate to Juvisync. The company's robust growth in these regions was driven by other products in the Januvia franchise, which had stronger market acceptance and clinical support[3].

Clinical and Regulatory Aspects

Juvisync's clinical profile was not the issue; the drug combined two well-established medications. However, regulatory and clinical factors, such as the need for different dosing in certain patient populations (e.g., those with severe renal insufficiency), may have added complexity to its adoption. The drug's approval and subsequent marketing did not overcome these challenges[4].

Conclusion of Sales

Merck's decision to stop selling Juvisync was purely based on business reasons, reflecting the drug's inability to gain market traction despite its theoretical benefits. This move highlighted the challenges of introducing new combination therapies into a crowded and competitive market.

Key Takeaways

• Market Need: Despite a clear medical need, Juvisync failed to capture a significant market share.
• Marketing Strategy: The marketing approach, while comprehensive, did not differentiate the product enough to drive adoption.
• Financial Performance: The drug's sales were significantly lower than expected and did not justify continued investment.
• Competitive Landscape: The competitive nature of the diabetes and cholesterol management markets made it difficult for Juvisync to stand out.
• Global Dynamics: Success in other regions with different products in the Januvia franchise did not translate to Juvisync.

FAQs

What was Juvisync, and what conditions did it treat?

Juvisync was a combination drug developed by Merck, combining the DPP-4 inhibitor Januvia (sitagliptin) with the statin Zocor (simvastatin), designed to treat Type 2 diabetes and high cholesterol.

Why did Merck stop selling Juvisync?

Merck stopped selling Juvisync due to business reasons, as the drug did not achieve the expected market traction and sales.

How did Juvisync's marketing strategy differ from other Januvia products?

Juvisync's marketing strategy included HCP-oriented and DTC marketing, emphasizing the drug as part of a comprehensive treatment program. However, it did not differentiate enough to drive significant adoption.

What were the competitive challenges faced by Juvisync?

Juvisync faced competition from other DPP-4 inhibitors and statins, which were already well-established in the market. The lack of a compelling differentiation made it difficult for Juvisync to gain market share.

Did Juvisync have any clinical or regulatory issues?

While Juvisync's clinical profile was not the issue, regulatory and clinical complexities, such as different dosing needs for certain patient populations, may have contributed to its poor adoption.

Sources

1. FiercePharma: Merck gives up on unsuccessful Januvia combo drug Juvisync
2. Blueprint Medicines: Fourth Quarter and Full Year 2022 Results
3. Pharmaceutical Executive: Brand of the Year: Januvia
4. Medical Marketing and Media: Juvisync