EXEM FOAM KIT Drug Patent Profile

Which patents cover Exem Foam Kit, and what generic alternatives are available?

Exem Foam Kit is a drug marketed by Giskit and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the air polymer-type a profile page.

DrugPatentWatch^® Generic Entry Outlook for Exem Foam Kit

Exem Foam Kit was eligible for patent challenges on November 7, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EXEM FOAM KIT

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	EXEM FOAM KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXEM FOAM KIT

Constraining patent/regulatory exclusivity:

9,034,300

NDA:

212279

Dosage:

FOAM;INTRAUTERINE

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for EXEM FOAM KIT

EXEM FOAM KIT is protected by three US patents.

This potential generic entry date is based on patent 9,034,300.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes	9,034,300		Y
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes	9,259,494		Y
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes	9,849,199		Y

International Patents for EXEM FOAM KIT

When does loss-of-exclusivity occur for EXEM FOAM KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Denmark

European Patent Office

Netherlands

Poland

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EXEM FOAM KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2488211
European Patent Office	2488211	Composition et procédé d'imagerie médicale de cavités corporelles (Composition and method for medical imaging of body cavities)
Netherlands	2003660
Poland	2488211
Spain	2529564
World Intellectual Property Organization (WIPO)	2011046437

Market Dynamics and Financial Trajectory for the ExEm Foam Kit

Introduction to ExEm Foam Kit

The ExEm Foam Kit, developed by Dutch gynecologists Dr. Niek Exalto and Prof. Dr. Mark Hans Emanuel, is a revolutionary tool in the field of infertility diagnosis. It is used for hysterosalpingo foam sonography (HyFoSy), a procedure that assesses the patency of the fallopian tubes using ultrasound technology. This innovation has significantly impacted the market for tubal patency testing, offering a less invasive and more patient-friendly alternative to traditional methods like X-ray hysterosalpingography (HSG) and laparoscopy.

Market Need and Demand

The demand for assisted reproductive technologies has been on the rise, driven by increasing rates of infertility and a growing preference for less invasive diagnostic procedures. With the introduction of ExEm Foam, there has been a notable shift towards ultrasound-based tubal patency testing. This is partly due to the downward trend in using radiation in women trying to conceive, as highlighted by Johan Remmerswaal, President of ExEm Foam Inc.[4].

Competitive Landscape

ExEm Foam is the only FDA-approved contrast agent for ultrasound tubal patency testing, giving it a unique position in the market. Traditional methods such as X-ray HSG and laparoscopy, while effective, come with significant drawbacks including the use of radiation and iodine, and the need for additional appointments. ExEm Foam's non-invasive nature and lack of radiation make it a preferred choice for many healthcare providers and patients[4].

Global Adoption and Usage

Since its launch in Europe in 2011, ExEm Foam has been used in over 1 million fallopian tubes worldwide, with more than 500,000 procedures conducted globally. Its availability has expanded to select fertility clinics in the United States following FDA approval in 2019. This widespread adoption underscores the product's efficacy and acceptance within the medical community[1][4].

Clinical Effectiveness

Multiple studies, including the 'FOAM Study' presented at the 2019 American Society of Reproductive Medicine (ASRM) Scientific Congress, have demonstrated that ExEm Foam has similar effectiveness to X-ray HSG. The study, which involved 1167 patients in 26 hospitals, found that 12-month pregnancy outcomes were similar for subfertile women who received HyFoSy with ExEm Foam compared to those who underwent X-ray HSG[3].

Cost and Insurance Coverage

The financial trajectory of ExEm Foam is influenced by its cost and insurance coverage. Depending on the insurance plan, ExEm Foam could be fully covered, resulting in no copay, deductible, or out-of-pocket costs for patients. Patients are advised to verify coverage with their insurance providers, using the J code: J3490. If not covered under medical benefits, it may be covered as a pharmacy benefit. For those without insurance or insufficient coverage, self-pay options are available through the pharmacy[2].

Revenue and Growth

The revenue generated by ExEm Foam is substantial, given its widespread use and the growing demand for assisted reproductive technologies. The product's availability in multiple regions, including Europe and the United States, contributes to its financial success. While exact revenue figures are not publicly disclosed, the fact that it has been used in over 500,000 procedures worldwide since its launch indicates a significant revenue stream.

Market Expansion and Future Prospects

ExEm Foam Inc is headquartered in Nashville, TN, and continues to expand its reach to more fertility clinics. The company's focus on providing innovative solutions to simplify infertility diagnosis and enhance the fertility journey positions it for continued growth. As more healthcare providers adopt the HyFoSy procedure, the demand for ExEm Foam is expected to increase, driving further market expansion and revenue growth[4].

Patient and Healthcare Provider Acceptance

The acceptance of ExEm Foam among patients and healthcare providers is high due to its less invasive nature and the absence of radiation. Patients appreciate the comfort and convenience of the procedure, which can be performed in the gynecologist's office. Healthcare providers value the accuracy and ease of use of the ExEm Foam Kit, making it a preferred diagnostic tool for tubal patency testing[4].

Regulatory Environment

ExEm Foam's FDA approval in 2019 was a significant milestone, validating its safety and efficacy. This regulatory approval has facilitated its adoption in the U.S. market and reinforced its position as a trusted diagnostic tool. Compliance with regulatory standards ensures that the product meets high safety and efficacy criteria, further enhancing its market credibility[4].

Safety and Efficacy

ExEm Foam has been proven to be safe and effective in numerous clinical trials. The product is indicated for use as a contrast agent for HyFoSy to assess fallopian tube patency in women with known or suspected infertility. The safety profile of ExEm Foam is robust, with no significant adverse effects reported in extensive clinical use[4].

Conclusion

The ExEm Foam Kit has revolutionized the field of infertility diagnosis by offering a less invasive, radiation-free alternative for tubal patency testing. Its widespread adoption, strong clinical evidence, and favorable insurance coverage have contributed to its financial success. As the demand for assisted reproductive technologies continues to grow, ExEm Foam is well-positioned for continued market expansion and revenue growth.

Key Takeaways

• Innovative Diagnostic Tool: ExEm Foam is the only FDA-approved contrast agent for ultrasound tubal patency testing.
• Global Adoption: Used in over 1 million fallopian tubes worldwide since its launch in 2011.
• Clinical Effectiveness: Proven to have similar effectiveness to X-ray HSG in multiple studies.
• Cost and Insurance: May be fully covered by insurance, with self-pay options available.
• Market Expansion: Continues to expand to more fertility clinics globally.
• Patient and Provider Acceptance: High acceptance due to its less invasive nature and absence of radiation.

FAQs

Q: What is the ExEm Foam Kit used for? A: The ExEm Foam Kit is used for hysterosalpingo foam sonography (HyFoSy) to assess the patency of the fallopian tubes in women with known or suspected infertility.

Q: Is ExEm Foam FDA-approved? A: Yes, ExEm Foam is FDA-approved as a contrast agent for ultrasound tubal patency testing.

Q: How does ExEm Foam compare to traditional methods like X-ray HSG? A: ExEm Foam is less invasive and does not use radiation, making it a preferred choice over traditional methods like X-ray HSG.

Q: Is ExEm Foam covered by insurance? A: Yes, ExEm Foam may be fully covered by insurance, depending on the specific plan. Patients should verify coverage with their insurance providers.

Q: Where is ExEm Foam available? A: ExEm Foam is available at select fertility clinics in Europe and the United States.

Sources

1. The Science - ExEm Foam. Exemfoam.eu.
2. Cost and Insurance Coverage - ExEm Foam. Exemfoam.com.
3. The Science - ExEm Foam. Exemfoam.com.
4. ExEm® Foam, the only FDA-approved contrast agent for ultrasound tubal patency testing, is now available at select fertility clinics nationwide. Exemfoam.com.
5. ExEm Foam Kit - Idoman Teoranta. Idoman-med.com.