RENOVA Drug Patent Profile

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

Renova is a drug marketed by Valeant Pharms North and is included in two NDAs.

The generic ingredient in RENOVA is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Renova

A generic version of RENOVA was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for RENOVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for RENOVA
What excipients (inactive ingredients) are in RENOVA?	RENOVA excipients list
DailyMed Link:	RENOVA at DailyMed

See drug prices for RENOVA

Recent Clinical Trials for RENOVA

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

Sponsor	Phase
Dwight Owen	Phase 1
OHSU Knight Cancer Institute	Phase 1
Prospect Creek Foundation	Phase 1

See all RENOVA clinical trials

Pharmacology for RENOVA

Drug Class

Retinoid

US Patents and Regulatory Information for RENOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000		RX	Yes	Yes
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995		DISCN	Yes	No

Expired US Patents for RENOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995

International Patents for RENOVA

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

Country	Patent Number	Title	Estimated Expiration
Canada	1324962	COMPOSITIONS ET METHODES POUR RETARDER LES EFFETS DU VIEILLISSEMENT DE LA PEAU (COMPOSITIONS AND METHODS FOR RETARDING THE EFFECTS OF AGING OF THE SKIN)
South Korea	950014443
Australia	598454

Supplementary Protection Certificates for RENOVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RENOVA

Last updated: July 29, 2025

Introduction

Renova, branded as a topical agent primarily indicated for skin conditions, has garnered significant attention within dermatological and pharmaceutical markets. Its active compound, tazarotene, is a topical retinoid initially approved for acne and psoriasis but has expanded into other dermatological indications, notably for cosmetic purposes such as wrinkle and melasma treatment. The evolving landscape of dermatologic therapies, regulatory shifts, and demographic trends shape Renova's market dynamics and financial outlook. This analysis delineates the factors influencing Renova’s market trajectory, competitive positioning, and future revenue potential.

Market Overview and Product Indication Scope

Renova is approved for the management of fine facial wrinkles and mottled hyperpigmentation associated with sun damage. Its dermatological efficacy, combined with the rising demand for anti-aging and skin rejuvenation therapies, positions it favorably in a growing market segment. According to recent market research, the global dermatology market is projected to expand at a CAGR of approximately 8% through 2027, driven by aging populations, increasing dermatological conditions, and advances in topical and systemic therapies [1].

While originally Pain Health’s Renova’s primary indications centered around psoriasis and acne (with tazarotene being the active molecule), its reformulation and labeling as a cosmetic anti-aging agent have expanded its commercial scope. Consequently, the drug's market dynamics are influenced both by prescription sales and over-the-counter (OTC) cosmetic application trends.

Key Market Drivers

1. Growing Anti-Aging Market Demand

The anti-aging segment represents a core growth driver. As populations age globally, particularly in developed economies, demand for effective dermatological anti-wrinkle treatments rises. A report indicates that the anti-aging skincare market accounted for $49 billion in 2020, with a projected CAGR exceeding 7% [2]. Renova's efficacy in reducing fine lines aligns with consumer preferences for non-invasive, topical solutions, augmenting its market potential.

2. Elevating Cosmetic Dermatology Procedures

The shift towards minimally invasive procedures, such as topical retinoids, enhances the market appeal of products like Renova. Market surveys reveal increased consumer willingness to adopt prescription-strength skincare products, especially when marketed with perceived safety and proven efficacy [3].

3. Positive Regulatory and Clinical Validation

Robust clinical data supporting Renova-driven improvements in skin texture and pigmentation bolster its positioning. Regulators' acceptance of its expanded indications, including cosmetic uses in certain jurisdictions, facilitates broader access. However, regulations vary; some countries restrict prescription-only status for anti-aging claims, affecting sales scalability.

4. Demographic Trends

Aging populace and increased skin health awareness contribute to sustained demand. The baby boomer generation, a significant consumer base for anti-aging products, is increasingly seeking prescription-grade skincare, driving both dermatologist-prescribed usage and OTC sales.

5. Competitive Landscape and Product Differentiation

Renova faces competition primarily from other topical retinoids like tretinoin (Retin-A), adapalene, and newer agents with improved tolerability profiles. Its unique positioning as a formulation targeting hyperpigmentation and fine wrinkles offers differentiation, yet price sensitivity and cosmeceutical alternatives challenge its market share.

Market Constraints and Challenges

1. Safety and Tolerability Concerns

Retinoids, including tazarotene, often induce skin irritation, erythema, and photosensitivity, which may limit widespread adoption. Patient education and dermatologist oversight become essential, thus constraining rapid OTC market penetration.

2. Regulatory Barriers and Labeling

In various jurisdictions, the anti-aging claims of prescription drugs like Renova face regulatory scrutiny, impacting marketing strategies. Restrictions on off-label uses and advertising limit direct consumer marketing, impacting sales volume.

3. Patent Challenges and Generic Competition

Patent expirations threaten exclusivity. While tazarotene formulations have historically enjoyed patent protection, generic versions have entered the market, exerting downward pressure on prices and profit margins.

4. Market Saturation and Consumer Preferences

The explosion of over-the-counter cosmeceuticals boasting similar ingredients—retinol, bakuchiol, or plant-derived compounds—pose substitution threats. Consumers increasingly favor OTC products for convenience and lower costs, potentially reducing prescription-driven revenues.

Financial Trajectory and Revenue Projections

Historical Performance

Historically, Renova’s revenue was driven predominantly by prescription sales within dermatology clinics. Its niche indication for photoaging and hyperpigmentation contributed to steady sales in developed markets. However, recent data suggest stagnation in growth owing to increased generic competition and market saturation.

Projected Growth Outlook

Forecast models posit that Renova’s global sales could grow at a CAGR of 4-6% over the next five years, contingent on several factors:

• Successful expansion into emerging markets with rising skin health awareness.
• Strategic marketing collaborations emphasizing its anti-aging benefits.
• Development of new formulations or combination products enhancing efficacy and tolerability.

Impact of Market Penetration Strategies

Pharmaceutical companies investing in clinical trials that validate off-label cosmetic applications might unlock new revenue streams. Moreover, transitioning some formulations for OTC availability, pending regulatory approval, could considerably elevate sales volumes.

Influence of Regulatory Environments

Regulatory landscapes will considerably influence Renova’s financial trajectory. In markets where anti-aging claims are permissible and OTC sales are allowed, sales could accelerate. Conversely, intensified regulatory hurdles could constrain growth prospects.

Cost Considerations

Manufacturing costs for specialized formulations remain stable, but marketing, regulatory compliance, and patent litigation expenses influence profitability. Effective patent management and supply chain efficiencies will be vital for sustained revenue.

Competitive Positioning and Market Share

Renova’s unique positioning as a dermatologically approved anti-aging agent provides leverage against generic retinoids and topical cosmeceuticals. Nonetheless, competition remains fierce. Key strategies include:

• Differentiated marketing highlighting clinical efficacy.
• Broadening indications through ongoing clinical trials.
• Formulation improvements to reduce irritation and improve user compliance.

Partnerships with dermatologists and aesthetic clinics bolster its prescription base, but direct-to-consumer marketing remains limited due to regulatory restrictions.

Regulatory and Innovation Trends

Emerging regulatory trends favor minimal side-effect profiles and proven efficacy. Innovations include combining tazarotene with other active ingredients, such as antioxidants, to enhance outcomes and tolerability—an avenue for future revenue growth.

Furthermore, advances in delivery systems, such as microencapsulation or nanotechnology, could improve skin penetration and reduce irritation, enlarging Renova’s appeal across broader patient populations.

Key Market Segments and Outreach Strategies

• Prescribed dermatology: Continued focus on dermatologist-led initiatives for anti-aging and hyperpigmentation treatments.
• Cosmetic segment: Formulation modifications for OTC use aimed at consumers seeking non-prescription solutions.
• Emerging markets: Capitalizing on expanding middle-class populations and rising disposable incomes, especially in Asia-Pacific.

Conclusion

Renova’s market dynamics rest upon the convergence of demographic trends, product differentiation, regulatory frameworks, and competitive pressures. While current revenue streams face headwinds from generics and market saturation, strategic innovation and expansion into emerging markets could sustain mid-term growth. The drug’s positioning within the anti-aging market niche and potential formulations advancements underpin a cautiously optimistic financial trajectory.

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Key Takeaways

• Renova benefits from an expanding anti-aging skincare market driven by aging demographics and rising consumer demand for non-invasive therapies.
• Regulatory hurdles and generic competition present significant challenges, necessitating strategic innovation and formulation improvements.
• Market growth hinges on expanding beyond prescription domains into OTC segments, especially in emerging markets.
• Technological advancements in drug delivery may enhance tolerability, broadening user bases.
• Aligning with dermatological and aesthetic practice trends enhances market penetration and sales stability.

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FAQs

1. What are the primary indications for Renova?
Renova is primarily approved for treating fine facial wrinkles and mottled hyperpigmentation associated with sun damage, with some formulations also used for psoriasis and acne.

2. How does Renova compare to other topical retinoids?
Renova (tazarotene) offers a potent retinoid effect with proven efficacy in anti-aging and pigmentation reduction. However, it may cause more skin irritation compared to tretinoin or adapalene, necessitating cautious use.

3. What regulatory hurdles does Renova face in expanding its market?
Restrictions on off-label anti-aging claims, national variations in prescription requirements, and potential future restrictions on topical retinoid formulations limit rapid market expansion.

4. How does patent status affect Renova’s financial outlook?
Patent expirations open the market to generics, reducing pricing power and margins. Continued innovation and formulation patents are essential to sustain profitability.

5. What growth strategies can enhance Renova’s future revenue?
Expanding into OTC markets, developing combination therapies, entering emerging economies, and improving formulations for tolerability are key to driving growth.

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References:

[1] Market Research Future, "Dermatology Market Forecast," 2022.
[2] Grand View Research, "Anti-Aging Skincare Market Analysis," 2021.
[3] Statista, "Cosmetic Dermatology Trends," 2022.