SOLTAMOX Drug Patent Profile

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

Soltamox is a drug marketed by Mayne Pharma Commrcl and is included in one NDA.

The generic ingredient in SOLTAMOX is tamoxifen citrate. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Soltamox

A generic version of SOLTAMOX was approved as tamoxifen citrate by ACTAVIS LABS FL INC on February 20^th, 2003.

Summary for SOLTAMOX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	21
Drug Prices:	Drug price information for SOLTAMOX
What excipients (inactive ingredients) are in SOLTAMOX?	SOLTAMOX excipients list
DailyMed Link:	SOLTAMOX at DailyMed

See drug prices for SOLTAMOX

Recent Clinical Trials for SOLTAMOX

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

Sponsor	Phase
Jose Pablo Leone	Phase 2
Translational Breast Cancer Research Consortium (TBCRC)	Phase 2
Eli Lilly and Company	Phase 2

See all SOLTAMOX clinical trials

Pharmacology for SOLTAMOX

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for SOLTAMOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005		RX	Yes	Yes

Expired US Patents for SOLTAMOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005

International Patents for SOLTAMOX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0893121
European Patent Office	0893121	Solution liquide de médicament pour administration orale (Oral liquid medicine solution)
Austria	214269

SOLTAMOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Soltamox (Tamoxifen)

Overview of Soltamox

Soltamox, the brand name for tamoxifen, is a selective estrogen receptor modulator (SERM) widely used in the treatment of estrogen receptor-positive breast cancer. It is also prescribed to reduce the risk of invasive breast cancer in high-risk women and to lower the occurrence of breast cancer after radiation and surgery[1][4].

Market Position and Competition

Generic vs. Brand Name

Soltamox is available as both a generic and brand-name drug. The generic version of tamoxifen is considered as safe and effective as the brand-name version but tends to be less expensive. This dual availability impacts the market dynamics, as patients and healthcare providers often opt for the generic version due to cost considerations[4].

Market Trends

The pharmaceutical market, particularly in the oncology segment, is highly competitive and dynamic. Trends such as the increasing demand for targeted therapies and the growing importance of specialty pharmaceutical channels are reshaping the market. Companies like Midatech Pharma, which has an exclusive license to distribute Soltamox, are focusing on building strong sales and marketing capabilities to leverage these trends[3][5].

Financial Performance

Revenue and Growth

Midatech Pharma, the company responsible for the commercialization of Soltamox, has seen significant revenue growth. In 2015, the company reported a total revenue increase of 763% to £1.38 million, largely driven by the acquisition of new products and the expansion of its sales and marketing capabilities. This growth indicates a strong financial trajectory for Soltamox as part of Midatech's product portfolio[2][5].

Cash Reserves and Investments

Despite the revenue growth, Midatech Pharma incurred a net loss after tax of £10.10 million in 2015, primarily due to non-recurring expenses related to acquisitions and the listing of American Depositary Receipts (ADRs) on NASDAQ. However, the company maintained strong cash reserves of £16.18 million, which is crucial for ongoing research and development (R&D) and future growth initiatives[2][5].

Cost and Pricing

Factors Influencing Cost

The cost of Soltamox can vary based on several factors, including the treatment plan, insurance coverage, and the pharmacy used. Generic tamoxifen is generally more affordable than the brand-name Soltamox, but insurance coverage may influence the choice between the two[4].

Savings and Assistance

Patients can save on Soltamox prescriptions through various means, such as using Optum Perks coupons or exploring financial assistance programs. These initiatives help make the medication more accessible to those in need[4].

Distribution and Marketing

Sales and Marketing Capabilities

Midatech Pharma's acquisition of Soltamox, along with other oncology-focused products like Gelclair and Oravig, has enhanced its sales and marketing capabilities in the U.S. market. This established sales channel is expected to support the commercialization of Midatech's oncology products currently under development, subject to regulatory approval[2][5].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of Soltamox. FDA approval, which tamoxifen received in 1977, is essential for its use. Any changes in regulatory requirements or the approval of new treatments could impact the market position of Soltamox[1].

Future Outlook

Growth Potential

Midatech Pharma's strategy, which includes the commercialization of Soltamox and other oncology products, is expected to drive future growth. The company's focus on building a strong sales and marketing channel, along with its dual listing on NASDAQ, positions it well for long-term profitability and growth[2][5].

R&D and Pipeline

The company's R&D spend, which was £5.92 million in 2015, indicates a commitment to developing new treatments. This ongoing investment in research and development is crucial for maintaining a competitive edge in the oncology market and ensuring the continued relevance of Soltamox and other products in the portfolio[5].

Key Takeaways

• Market Position: Soltamox is a key player in the treatment of estrogen receptor-positive breast cancer, with both generic and brand-name versions available.
• Financial Performance: Midatech Pharma has seen significant revenue growth, though it has also incurred net losses due to non-recurring expenses.
• Cost and Pricing: The cost of Soltamox varies based on treatment plans, insurance, and pharmacies, with savings options available through coupons and assistance programs.
• Distribution and Marketing: Strong sales and marketing capabilities, enhanced by recent acquisitions, support the commercialization of Soltamox and other oncology products.
• Future Outlook: Midatech Pharma's strategy and ongoing R&D investments position Soltamox for continued growth and relevance in the oncology market.

FAQs

Q: What is Soltamox used for?

A: Soltamox (tamoxifen) is used to treat estrogen receptor-positive breast cancer, reduce the risk of invasive breast cancer after surgery, and lower the occurrence of breast cancer in high-risk women[1][4].

Q: How does the cost of Soltamox compare to its generic version?

A: The generic version of tamoxifen is generally less expensive than the brand-name Soltamox, but costs can vary based on insurance coverage and the pharmacy used[4].

Q: What company is responsible for the commercialization of Soltamox?

A: Midatech Pharma has an exclusive license to distribute and market Soltamox, along with other oncology-focused products[2][5].

Q: What are the key factors influencing the financial performance of Midatech Pharma?

A: Midatech Pharma's financial performance is influenced by revenue growth from product sales, non-recurring expenses related to acquisitions, and ongoing R&D investments[2][5].

Q: How does Midatech Pharma plan to drive future growth for Soltamox and other products?

A: Midatech Pharma plans to drive future growth through enhanced sales and marketing capabilities, ongoing R&D investments, and the commercialization of new oncology products subject to regulatory approval[2][5].

Sources

1. DrugBank Online: Tamoxifen: Uses, Interactions, Mechanism of Action.
2. GlobeNewswire: Midatech Pharma PLC Audited financial results for the year ended 31 December 2015.
3. Pharmacy Times: Assessing Specialty Pharmaceutical Trends Reshaping the Field for the Future.
4. MedicalNewsToday: Tamoxifen cost 2024: Coupons and more.
5. Annual Reports: Midatech Pharma plc Annual Report & Accounts 2015.