ORAVIG Drug Patent Profile

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

Oravig is a drug marketed by Galt Pharms and is included in one NDA.

The generic ingredient in ORAVIG is miconazole. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the miconazole profile page.

Summary for ORAVIG

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	4,985
Drug Prices:	Drug price information for ORAVIG
What excipients (inactive ingredients) are in ORAVIG?	ORAVIG excipients list
DailyMed Link:	ORAVIG at DailyMed

See drug prices for ORAVIG

Pharmacology for ORAVIG

Drug Class

Azole Antifungal

US Patents and Regulatory Information for ORAVIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010		RX	Yes	Yes

Expired US Patents for ORAVIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	6,916,485
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	8,518,442
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	7,651,698

International Patents for ORAVIG

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1408911	SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE (SUSTAINED-RELEASE THERAPEUTIC BIOADHESIVE SYSTEMS)
Denmark	1792610
Spain	2316108
Denmark	1408911

ORAVIG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oravig

Introduction to Oravig

Oravig, known as Loramyc in Europe, is an orally-dissing buccal tablet approved for the treatment of oropharyngeal candidiasis, commonly referred to as oral thrush. This innovative product has been a focal point in the supportive care segment of the pharmaceutical industry, particularly for patients undergoing cancer treatments.

Market Demand and Segmentation

The market demand for Oravig is significant, particularly in the primary care segment. In the United States, more than three million prescriptions are written annually for oral thrush, with the majority of these prescriptions coming from primary care providers[1].

Regional Market Insights

• North America: This region has been a key market for Oravig, driven by high healthcare spending and a significant incidence of cancers. The product's launch and subsequent promotions have been tailored to capitalize on this demand[1][4].
• Asia Pacific: While not the primary focus for Oravig, the Asia Pacific region is experiencing a rise in oncological anomalies, which could potentially expand the market for supportive care products like Oravig in the future[3].

Competitive Landscape

Oravig operates in a competitive market for oral chemotherapy and supportive care products. However, its unique formulation as an orally-dissolving buccal tablet provides a distinct advantage in terms of ease of use and patient compliance, especially for patients with difficulty swallowing[4].

Commercialization and Partnerships

The commercialization of Oravig has involved several strategic partnerships:

• DARA BioSciences: DARA acquired the exclusive rights to market and sell Oravig in the United States from Onxeo S.A. and entered into a co-promotion agreement with Mission Pharmacal Company to target the primary care market[1].
• Vestiq Pharmaceuticals: Previously, BioAlliance Pharma partnered with Vestiq Pharmaceuticals for the launch of Oravig in the United States. Vestiq's specialized portfolio in supportive care products was instrumental in promoting Oravig[4].

Financial Trajectory

Revenue and Sales

• The acquisition of Oravig by DARA BioSciences included milestone payments to Onxeo S.A. based on defined sales thresholds. This structure indicates a potential for significant revenue growth as sales targets are met[1].
• The global oral chemotherapy market, which includes supportive care products like Oravig, is expected to grow at a CAGR of 8.3% from 2023 to 2029, reaching nearly $2.55 billion by 2029[3].

Cost and Investment

• The commercialization and promotion of Oravig involve substantial investment. For instance, DARA's agreement with Mission Pharmacal and the execution of a pediatric study as part of a post-marketing commitment require significant financial resources[1].
• Companies involved in the development and commercialization of Oravig, such as BioAlliance Pharma and Midatech Pharma, have reported significant investments in research and development, as well as in building their commercial operations[2][5].

Profitability and Break-Even Points

• Midatech Pharma, another company involved in the oncology supportive care market, reported that its US commercial business broke even on an EBITDA basis for the first time in H2 2017, indicating the potential for profitability in this segment[2].
• The success of Oravig in achieving sales milestones and expanding its market size could lead to increased profitability for its commercial partners.

Regulatory Approvals and Clinical Studies

• Oravig has received regulatory approvals in the United States and has the potential for expanded indications through post-marketing commitments, such as the pediatric study undertaken by DARA BioSciences[1].
• Regulatory approvals and the completion of clinical studies are crucial for the financial trajectory of Oravig, as they can lead to expanded market access and increased revenue.

Key Takeaways

• Oravig operates in a high-demand market for oral thrush treatments, particularly in the primary care segment.
• Strategic partnerships have been instrumental in its commercialization.
• The product's unique formulation provides a competitive edge.
• The financial trajectory is influenced by milestone payments, investment in promotion and research, and regulatory approvals.
• The global oral chemotherapy market's growth prospects are favorable for Oravig's revenue potential.

FAQs

1. What is Oravig used for? Oravig is used for the treatment of oropharyngeal candidiasis, commonly known as oral thrush.

2. Who are the key partners involved in the commercialization of Oravig? Key partners include DARA BioSciences, Onxeo S.A., Mission Pharmacal Company, and previously, Vestiq Pharmaceuticals.

3. What is the market size for oral thrush treatments in the United States? More than three million prescriptions are written annually for oral thrush in the United States.

4. How does Oravig's unique formulation benefit patients? Oravig's orally-dissolving buccal tablet formulation provides ease of use and improved patient compliance, especially for patients with difficulty swallowing.

5. What are the growth prospects for the oral chemotherapy market, which includes Oravig? The global oral chemotherapy market is expected to grow at a CAGR of 8.3% from 2023 to 2029, reaching nearly $2.55 billion by 2029.

Cited Sources:

1. DARA BioSciences Announces the Acquisition of Exclusive North American Rights to Oravig Miconazole Buccal Tablets 50mg from Onxeo S.A. - Marketwired
2. Midatech Pharma plc - Annual Reports - Annual Reports
3. Oral Chemotherapy Market: Global Industry Analysis and Forecast - Maximize Market Research
4. BIOALLIANCE PHARMA : announces the launch of Oravig® in the United States by its new partner, Vestiq Pharmaceuticals - Marketscreener
5. A Year of Major Progress - Annual Reports - Annual Reports