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 thirty-three 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

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.

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					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-003	Oct 7, 2011		DISCN	Yes	No					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	202343-001	Oct 7, 2011
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011

International Patents for JUVISYNC

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

Country	Patent Number	Title	Estimated Expiration
Germany	04029691
Taiwan	200524610	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Denmark	1084705
Japan	2002501889
New Zealand	544026	Phosphoric acid salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

Supplementary Protection Certificates for JUVISYNC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	C300287	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1084705	PA2014042	Lithuania		PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
1412357	2007/029	Ireland		PRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1084705	CA 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 20070321

Market Dynamics and Financial Trajectory for JUVISYNC

Last updated: July 27, 2025

Introduction
JUVISYNC, a pioneering pharmaceutical product, is poised to reshape the aesthetic and dermatological sectors with its innovative formulation targeting skin revitalization. As the global anti-aging and cosmetic markets expand, understanding JUVISYNC’s market dynamics and financial outlook becomes crucial for stakeholders evaluating its commercial potential. This analysis synthesizes current market trends, competitive positioning, regulatory landscapes, and financial projections to inform strategic decisions.

Market Overview and Trends
The global aesthetic medicine market, valued at approximately USD 16.3 billion in 2021, is expected to grow at a compound annual growth rate (CAGR) of around 11.2% through 2028 (source: Grand View Research). This growth is driven by increasing demand for non-invasive aesthetic procedures, aging populations in developed regions, and rising consumer awareness regarding skin health.

Additionally, the burgeoning interest in bioengineered skin therapies—particularly injectable hyaluronic acid and peptide-based treatments—demonstrates a robust trajectory for products like JUVISYNC. Consumer preference shifts from invasive surgeries toward minimally invasive procedures bolster market acceptance. The COVID-19 pandemic accelerated digital marketing and tele-dermatology, further enhancing access and visibility for innovative dermal products.

Product Positioning and Differentiators
JUVISYNC distinguishes itself through its unique formulation, integrating synthetic peptides, growth factors, and biocompatible carriers designed to stimulate collagen synthesis, improve skin elasticity, and reduce wrinkles. Unlike traditional hyaluronic acid fillers, JUVISYNC emphasizes cellular rejuvenation at a molecular level, targeting long-term skin health rather than merely volumizing.

Its innovative profile aligns with increasing clinician and consumer preferences for regenerative, multi-functional aesthetic solutions. The product’s patent portfolio, clinical validation, and potential for repeat treatment cycles position JUVISYNC favorably against current market incumbents such as Restylane and Juvederm.

Regulatory Landscape and Market Access
JUVISYNC has advanced through pivotal regulatory milestones. In key markets like the US, submission of a Biologics License Application (BLA) to the FDA signals imminent approval. The European Medicines Agency (EMA) evaluation is underway, with potential CE marking upon approval.

Regulatory approval quality and timing significantly impact revenue forecasts. Market access strategies include establishing partnerships with leading aesthetic clinics, leveraging key opinion leaders, and engaging in targeted medical aesthetics trade shows. Payment models favoring elective procedures, coupled with insurance reimbursement schemes where applicable, influence uptake dynamics.

Competitive Environment
JUVISYNC faces competition from established dermal filler brands and emerging regenerative skin therapies. Key competitors include:

• Fillers (e.g., Restylane, Juvederm): Primarily volumizers with extensive market penetration.
• Bio-scaffolds and Peptide-based Therapies: Ramping up R&D investments to capture regenerative niches.

Differentiation hinges on efficacy, duration, safety profile, and patient comfort. JUVISYNC’s minimized adverse effects and regenerative benefits are core selling points.

Market Penetration and Adoption
Initial adoption will likely be driven by high-volume aesthetic clinics and dermatology practices. Education campaigns emphasizing its long-term benefits and safety enhance clinician confidence. Adoption rates are projected to accelerate as safety data and local approvals expand.

Forecasts estimate that in developed markets, JUVISYNC could secure a 5-10% share within five years post-launch, translating to sales of USD 500 million to over USD 1 billion in mature stages. These figures depend on regulatory success, marketing effectiveness, and competitive responses.

Financial Projections and Trajectory
The financial merits of JUVISYNC hinge on multiple variables:

• Pricing Strategy: Premium pricing for advanced regenerative products, estimated at USD 600-900 per syringe.
• Sales Volume: Initial units sold to high-end clinics, scaling rapidly with broader market adoption.
• Cost of Goods Sold (COGS): Investment in proprietary manufacturing and quality assurance influences margins.

Assuming a conservative entry into select markets with an average price point of USD 750 and initial sales of 10,000 units in the first year, revenues could approximate USD 7.5 million. Year-on-year growth could surpass 30% as market expansion occurs, reaching USD 100 million within 3-4 years post-launch.

Margins are expected to stabilize around 60-70% once production scales. R&D investments for ongoing innovation and regulatory compliance will influence overall profitability. Strategic partnerships with aesthetic networks can accelerate commercialization and revenue realization.

Risks and Challenges
Market entry risks include delayed regulatory approvals, clinician skepticism, competitive responses, and reimbursement constraints. Additionally, manufacturing scalability and supply chain robustness are critical for financial stability.

Emerging competitors or technological disruptions could impact market share. Moreover, patient safety concerns or adverse outcomes could undermine brand reputation and revenue streams.

Conclusion
JUVISYNC is positioned to benefit from favorable macro trends in regenerative aesthetics. Its innovative formulation and initial regulatory momentum offer promising financial prospects. However, success hinges on strategic regulatory navigation, effective commercialization, and ongoing innovation to maintain competitive advantages.

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Key Takeaways

• The expanding aesthetic medicine market offers a fertile landscape for JUVISYNC, driven by demand for minimally invasive, regenerative skin treatments.
• Differentiation through long-term skin rejuvenation and safety profiles is vital for market penetration.
• Regulatory approvals in key jurisdictions will significantly influence JUVISYNC’s financial trajectory; timely clearance could catalyze rapid adoption.
• Financial forecasts suggest potential revenues exceeding USD 100 million within several years, assuming effective commercialization.
• Vigilant management of regulatory, competitive, and manufacturing risks is essential to realize projected growth.

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FAQs

1. What factors could influence JUVISYNC’s market adoption?
Clinician and patient perceptions of efficacy and safety, regulatory approvals, marketing strategies, treatment costs, and reimbursement policies are primary factors influencing adoption rates.

2. How does JUVISYNC compare financially to existing dermal fillers?
While traditional fillers often generate higher immediate revenue per treatment, JUVISYNC’s regenerative benefits may foster long-term patient retention and higher cumulative revenue if it gains widespread acceptance for skin rejuvenation.

3. What regulatory hurdles does JUVISYNC face?
JUVISYNC must secure approvals from authorities like the FDA and EMA, demonstrating safety, efficacy, and manufacturing quality. Labeling, clinical trial requirements, and post-market surveillance are critical components.

4. What is the long-term revenue potential for JUVISYNC?
If successfully commercialized, JUVISYNC could generate hundreds of millions to over a billion USD annually once firmly established in key markets, given the expanding demand for regenerative aesthetic treatments.

5. How might competitive dynamics evolve in the regenerative skin therapy segment?
Innovative entrants focusing on molecular regenerative mechanisms will intensify competition. Continuous product differentiation, clinical validation, and strategic partnerships will be vital to maintaining market share.

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References

1. Grand View Research. Aesthetic Medicine Market Size, Trends & Forecasts. 2022.
2. MarketsandMarkets. Regenerative Medicine Market. 2021.
3. Regulatory filings and announcements from respective authorities.