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:	140
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
Oregon Health and Science University	Phase 1
OHSU Knight Cancer Institute	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	4,603,146
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	RE36068
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,877,805

International Patents for RENOVA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0182183	BELT CHAIN FOR ROOT CROP HARVESTERS
Japan	S59164710	TACKINESS PREVENTING COMPOSITION FOR COSMETICS
Australia	7804687
Japan	2606711

Supplementary Protection Certificates for RENOVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
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	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

RENOVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RENOVA

Overview of RENOVA Inc.

RENOVA Inc., a company primarily involved in the renewable energy and infrastructure sectors, has recently made significant strides in its financial performance and market presence. Here, we will delve into the market dynamics and financial trajectory of RENOVA, particularly focusing on its recent developments and future outlook.

Market Performance

Revenue Growth

RENOVA Inc. has reported a robust increase in revenue for the first half of 2024, with a notable 81.6% rise compared to the previous year. This significant growth is attributed to strong operational performance, particularly from the start of operations of several biomass and solar projects such as Tokushima Tsuda Biomass, Sendai-Gamo Biomass, and Hitoyoshi Solar[3][5].

Operational Highlights

The financial results for the fiscal year ending March 2024 show substantial revenue and EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) growth. The revenue increased from ¥33,581 million in FY2023 to ¥44,748 million in FY2024, representing a 33.3% year-on-year increase. However, the EBITDA margin saw a decline from 53.9% to 37.3% due to various one-time gains and expenses[5].

Financial Trajectory

Current Financials

For the fiscal year ending March 2024, RENOVA's financial highlights include:

• Revenue: ¥44,748 million, up 33.3% from the previous year.
• EBITDA: ¥16,712 million, with a margin of 37.3%.
• Operating Profit: ¥5,017 million, down 43.4% due to one-time gains and expenses.
• Profit Attributable to Owners: ¥8,857 million, reflecting a decline of 33.4%[5].

Future Projections

Looking ahead to FY2025, RENOVA forecasts continued growth:

• Revenue: Expected to increase to ¥71,800 million, a 60.5% rise from FY2024.
• EBITDA: Projected to be ¥20,800 million, with a margin of 29.0%.
• Operating Profit: Forecasted to be ¥1,000 million, a significant decline from FY2024.
• Profit Attributable to Owners: Expected to be ¥5,900 million, down from the previous year[5].

Market Dynamics

Drivers of Growth

The robust revenue growth for RENOVA is driven by several key factors:

• Operational Start-ups: The commencement of operations at new biomass and solar projects has significantly contributed to the revenue increase.
• Stable Cash Flow: The company has managed to create substantial cash flow from its stable operations, which is crucial for future investments and growth[5].

Challenges

Despite the strong revenue growth, RENOVA faces several challenges:

• Decline in Operating Profit: The operating profit saw a significant decline due to one-time gains and expenses, which could impact the company's profitability in the short term.
• EBITDA Margin Decline: The decrease in EBITDA margin from 53.9% to 37.3% indicates potential operational inefficiencies or increased costs[5].

Regulatory and Market Environment

Renewable Energy Market

RENOVA operates in a favorable market environment, with increasing global focus on renewable energy. The start of new biomass and solar projects aligns with the growing demand for sustainable energy solutions. However, the company must navigate regulatory changes and competitive pressures in the renewable energy sector[5].

Financial Market Impact

The financial performance of RENOVA, particularly the significant revenue growth, has implications for its stock performance. However, the decline in operating profit and EBITDA margin could raise concerns among investors. The company's ability to maintain stable cash flow and manage operational costs will be crucial in sustaining investor confidence[3].

Strategic Initiatives

Diversification and Expansion

RENOVA is focusing on diversifying its revenue streams through the development and operation of various renewable energy projects. This strategy aims to reduce dependence on any single project and ensure sustainable growth. The company is also exploring new business opportunities, such as the consolidation of biomass projects, to enhance its market position[5].

Technological Advancements

While RENOVA's primary focus is on renewable energy, the company can benefit from technological advancements in energy storage, smart grids, and other related technologies. Integrating these innovations into its operations could further enhance efficiency and competitiveness[5].

Key Takeaways

• Revenue Growth: RENOVA has achieved significant revenue growth driven by the start of new renewable energy projects.
• Operational Performance: Despite revenue growth, the company faces challenges in maintaining operating profit and EBITDA margins.
• Future Projections: RENOVA forecasts continued revenue growth but anticipates a decline in operating profit.
• Market Environment: The company operates in a favorable renewable energy market but must navigate regulatory and competitive challenges.
• Strategic Initiatives: Diversification and technological advancements are key to RENOVA's sustainable growth strategy.

FAQs

Q: What drove RENOVA's significant revenue growth in 2024?

A: The revenue growth was primarily driven by the start of operations at new biomass and solar projects such as Tokushima Tsuda Biomass, Sendai-Gamo Biomass, and Hitoyoshi Solar.

Q: Why did RENOVA's operating profit decline despite revenue growth?

A: The decline in operating profit was due to one-time gains and expenses, which impacted the company's profitability in the short term.

Q: What are RENOVA's future revenue projections?

A: RENOVA forecasts revenue to increase to ¥71,800 million in FY2025, a 60.5% rise from FY2024.

Q: How does RENOVA plan to sustain its growth?

A: The company plans to diversify its revenue streams through the development and operation of various renewable energy projects and explore new business opportunities.

Q: What are the key challenges facing RENOVA?

A: RENOVA faces challenges such as declining operating profit, EBITDA margin decline, and navigating regulatory and competitive pressures in the renewable energy sector.

Sources

1. RENOVA Reports Robust Revenue Growth Amid Profit Challenges - Nasdaq
2. Briefing on Financial Results for the Fiscal Year Ending March 2024 - RENOVA Inc.
3. Financial Results for the Fiscal Year Ending March 2024 (IFRS) - RENOVA Inc.