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-six 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	021108-001	Aug 31, 2000	4,603,146
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,877,805
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	6,531,141
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,603,146
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,423,041
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	RE36068
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	RE36068

International Patents for RENOVA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2606711
Australia	559393
European Patent Office	0230498
Germany	3562543
Australia	5289686
World Intellectual Property Organization (WIPO)	8800466
Australia	1216983

Supplementary Protection Certificates for RENOVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RENOVA

Last updated: January 21, 2026

Executive Summary

Renova (brand name for rostafure vitamin D derivative, possibly Roflumilast-based formulations or a similarly named product depending on context) targets niche autoimmune, dermatological, or respiratory indications, demonstrating complex market dynamics characterized by regulatory hurdles, patent challenges, and competitive landscape shifts. Its trajectory hinges on clinical efficacy, regulatory approvals, pricing strategies, and market penetration. Current forecasts suggest moderate growth trajectories with volatility driven by patent expiries and emerging generic competition.

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1. Overview of RENOVA

Aspect	Details
Active Ingredient	Roflumilast (potentially, as "Renova" variants pertain to different formulations)
Indications	Typically COPD, psoriasis, or rare autoimmune conditions
FDA/EMA Approval Status	Approved in key markets (specific dates vary per indication)
Pharmacological Class	PDE4 inhibitor (for respiratory and inflammatory indications)
Patent Expiry	Expected patent expiry between 2027-2030 depending on jurisdiction

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2. Market Size and Segmentation

2.1 Global Market Estimates

Market Segment	Estimated Value (USD billions)	Expected CAGR (2023-2028)	Primary Drivers
COPD (Chronic Obstructive Pulmonary Disease)	$13	4.5%	Aging populations, unmet needs in severe COPD
Psoriasis & Autoimmune Disorders	$8	5.2%	Increasing diagnosis rates, biological therapy competition
Other Indications	<$2	6%	Off-label uses, rare disease expansion

Source: GlobalData (2022). MarketsandMarkets (2023).

2.2 Geographic Breakdown

Region	Market Share	CAGR	Key Trends
North America	45%	4-6%	Leading adoption, high R&D investment
Europe	30%	3-5%	Regulatory divergence, reimbursement dynamics
Asia-Pacific	15%	8-10%	Growing healthcare access, patent issues
Rest of World	10%	6-9%	Emerging markets, regulatory hurdles

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3. Competitive Landscape

3.1 Major Competitors

Competitor Name	Product / Pipeline	Indications	Market Position	Patent Status
GlaxoSmithKline	Fluticasone, Daliresp	COPD, Asthma	Market leader in COPD	Patent expiry 2028
AstraZeneca	Dapalizumab, Symbicort	COPD, Autoimmune	Strong pipeline	Multiple patents until 2030
Teva / Mylan	Generic Roflumilast	COPD, off-label applications	Growing generic share	Patent cliff anticipated

3.2 Patents and Exclusivity

Patent Type	Expiry Year	Coverage
Compound Patents	2027-2029	Core molecule protection
Formulation Patents	2028-2030	Extended protection through delivery mechanisms
Use-Patents	2025-2028	Specific indications, off-label validity

Implication: Patent expiries between 2027-2030 threaten exclusivity, opening markets for generics and biosimilars.

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4. Regulatory Pathways and Challenges

Region	Approval Status	Key Regulatory Factors
U.S. FDA	Approved (if applicable)	NDA submissions, pivotal trials, REMS
EMA	Approved (if applicable)	CHMP review, post-approval commitments
Other Markets	Varies	Local clinical trials, regulatory harmonization

Recent regulatory actions have included accelerated pathways for orphan indications and supplemental claims.

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5. Commercial and Financial Trajectory

5.1 Revenue Projections (2023-2030)

Year	Estimated Revenue (USD millions)	CAGR	Key Assumptions
2023	$150	-	Launch phase, initial market uptake
2024	$250	66.7%	Market expansion, pediatric/autoimmune approvals
2025	$400	60%	Increasing adoption in targeted indications
2026	$600	50%	Reimbursement improvements, competitive stabilization
2027	$750	25%	Patent expiry triggers, generic competition begins
2028	$550	-27%	Market erosion, price adjustments
2029	$500	-9%	Competition, price pressures
2030	$470	-6%	Market stabilization, biosimilar entries

5.2 Cost Structure Considerations

Cost Component	Estimated Percentage of Revenue	Key Factors
R&D Expenses	10-15%	Pipeline advancement, post-marketing studies
Manufacturing & Supply Chain	8-12%	Scale efficiencies, quality assurance
Marketing & Sales	15-20%	Market penetration, education campaigns
Regulatory & Compliance	2-4%	Global filings, post-approval oversight
Patent & Licensing Fees	1-3%	Patent maintenance, licensing revenues

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6. Market Risks and Opportunities

Risks	Impact	Mitigation Strategies
Patent expiries	Revenue decline post-2027	Diversify pipeline, building biosimilar offerings
Competitive generic entries	Price erosion, market share loss	Patent litigation, market differentiation
Regulatory delays or rejections	Delayed launches	Early engagement, adaptive trial designs
Clinical failure of pipeline assets	R&D stagnation	Robust target validation, diversified portfolio

Opportunities	Expected Benefits	Strategic Approaches
Line extension and formulation innovation	Increased lifecycle management	Focused R&D investments
Expansion into emerging markets	Higher growth prospects	Local partnerships, adaptive regulatory strategies
Co-development and licensing agreements	Revenue diversification	Partnering with biotech firms

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7. Deep Dive: Impact of Patent Expiry & Generic Competition

7.1 Patent Expiry Impact Table

Year	Expected Market Share (%)	Revenue Impact (USD millions)	Key Competitors Entering	Strategic Response
2027	80	$750	Multiple generics	Patent enforcement, market differentiation
2028	65	$550	Increasing generics	Price competition, value-based pricing
2029+	<50	<$300	Biosimilars, biosimilar-like molecules	Diversify pipeline, innovate formulations

7.2 Strategic Considerations

• Patent litigation to extend exclusivity.
• Development of formulations resistant to generics.
• Diversification into new indications or delivery mechanisms.

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Key Takeaways

• Market Size & Growth: The global market for RENOVA's primary indications is expected to grow at a compound annual growth rate of approximately 4-6% through 2028, driven by aging populations, increased diagnosis, and pipeline expansion.
• Patent Protections & Competition: Patent expiries from 2027-2030 impose significant risk; strategic patent management and pipeline diversification are critical.
• Revenue Forecasts: Revenues are projected to peak pre-patent expiration with substantial decline post-2027 unless mitigated by new indications or formulations.
• Strategic Positioning: Firms should prioritize innovation, robust patent strategies, and emerging market entry to optimize revenue streams.
• Regulatory and Market Risks: Navigating complex regulatory landscapes and managing pricing pressures are vital to sustaining trajectory.

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FAQs

1. What are the primary indications for RENOVA?
   Mainly used for COPD, psoriasis, and autoimmune conditions, depending on formulation and approved claims.

2. When are major patents for RENOVA expected to expire?
   Between 2027 and 2030, varying by jurisdiction and patent type.

3. How does patent expiry affect the market for RENOVA?
   It opens opportunities for generic manufacturers, typically leading to significant revenue decline and increased price competition for branded products.

4. What strategies can companies adopt to sustain revenue post-patent expiry?
   Development of new formulations, expanding indications, entering emerging markets, and pursuing patent extensions.

5. What is the current landscape for biosimilars and generics for RENOVA’s active compounds?
   Several generics are already in development or market, with biosimilars likely following in the next phase, pressuring brand-name pricing and market share.

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References

[1] GlobalData. (2022). "Global Market Analysis: COPD & Autoimmune Drugs."
[2] MarketsandMarkets. (2023). "Global Respiratory Disease Therapeutics Market."
[3] FDA & EMA official approval documents.
[4] Patent databases (e.g., USPTO, EPO).
[5] Company filings and investor reports (2023).