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BAFIERTAM Drug Patent Profile

When do Bafiertam patents expire, and when can generic versions of Bafiertam launch?

Bafiertam is a drug marketed by Banner Life Sciences and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has twenty patent family members in seven countries.

The generic ingredient in BAFIERTAM is monomethyl fumarate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the monomethyl fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Bafiertam

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 10, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BAFIERTAM

International Patents:	20
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	3
Patent Applications:	1,194
Drug Prices:	Drug price information for BAFIERTAM
What excipients (inactive ingredients) are in BAFIERTAM?	BAFIERTAM excipients list
DailyMed Link:	BAFIERTAM at DailyMed

See drug prices for BAFIERTAM

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BAFIERTAM

Constraining patent/regulatory exclusivity:

10,918,617

NDA:

210296

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

^*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.

Recent Clinical Trials for BAFIERTAM

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

Sponsor	Phase
Banner Life Sciences LLC	Phase 1

See all BAFIERTAM clinical trials

US Patents and Regulatory Information for BAFIERTAM

BAFIERTAM is protected by twenty-one US patents.

This potential generic entry date is based on patent 10,918,617.

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
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes	11,903,918
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes	10,918,617		Y
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes	9,814,692
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes	11,590,095
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes	10,098,863		Y

International Patents for BAFIERTAM

When does loss-of-exclusivity occur for BAFIERTAM?

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

Australia

Canada

Denmark

European Patent Office

Israel

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 BAFIERTAM around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	3110408
Israel	247326
Denmark	3501510
Australia	2015328676
Australia	2015328676	Controlled release enteric soft capsules of fumarate esters

BAFIERTAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BAFIERTAM

Introduction to BAFIERTAM

BAFIERTAM, also known as monomethyl fumarate, is a medication approved by the FDA in April 2020 as a treatment for multiple sclerosis (MS). It is considered a bioequivalent alternative to dimethyl fumarate (Tecfidera)[2].

Market Context: Multiple Sclerosis Drugs

The global multiple sclerosis drugs market is projected to grow significantly, reaching USD 33.59 billion by 2030 from USD 23.68 billion in 2021, with a CAGR of 3.9% from 2022 to 2030[1].

Route of Administration and Market Segment

BAFIERTAM is administered orally, which is a segment expected to register rapid market growth due to rising demand from MS patients. The oral segment benefits from the slow and steady release of the drug in the body, resulting in minimal side effects[1].

Competitive Landscape

In the competitive landscape of MS drugs, BAFIERTAM competes with other oral medications like ponesimod (Ponvory), which was FDA-approved in 2021 and has shown fewer brain lesions compared to other treatments. The market is also driven by the approval of new drugs, such as ofatumumab, a monoclonal antibody given subcutaneously, which has been shown to decrease brain lesions and other MS symptoms[1].

Pricing and Cost Dynamics

The pricing of BAFIERTAM is influenced by the broader dynamics of the prescription drug market. For instance, the average Wholesale Acquisition Cost (WAC) of generic Tecfidera, a similar drug, dropped significantly from $119 per capsule to $22 per capsule over a few months. This rapid decline highlights the potential for cost savings but also the complexity in pricing and profit margins for pharmaceutical benefit managers (PBMs)[3].

Patient Support Programs

To enhance patient access and affordability, BAFIERTAM offers several support programs. These include the $0 Copay Program, the QuickStart Program, and the Bridge Support Program. These programs help reduce treatment costs for patients with commercial insurance, provide a 30-day supply of the drug while insurance benefits are secured, and ensure continuity of therapy during gaps in coverage[5].

Regional Market Impact

The European market is expected to register a rapid CAGR due to increased funding for MS research and the approval of novel drugs. While BAFIERTAM is not specifically highlighted as a major driver in this region, the overall increase in R&D activities and funding for MS treatments contributes to the growing demand for MS drugs, including oral medications like BAFIERTAM[1].

Financial Projections and Revenue Growth

Although specific financial projections for BAFIERTAM are not detailed, its market share is expected to grow as part of the broader oral segment of MS drugs. The oral segment's growth is driven by patient preference for oral medications due to their ease of administration and reduced side effects. As the global MS market expands, BAFIERTAM is poised to benefit from this trend[1].

Industry Trends and Innovations

The MS drug market is witnessing notable progressions, including the FDA's approval of new treatments aimed at addressing specific symptoms like walking issues and muscular stiffness. These innovations, while not directly attributed to BAFIERTAM, indicate a favorable market environment for new and existing MS treatments[4].

Regulatory Environment

The regulatory environment, particularly the FDA's Generic Drug User Fee Amendments (GDUFA), plays a crucial role in shaping the market. These amendments facilitate the approval process for generic drugs, which can impact the pricing and availability of drugs like BAFIERTAM[4].

Geographical Landscape

North America currently holds the largest share of the MS market, driven by growth in drug approvals, an increasing incidence of MS, and governmental efforts. The Asia Pacific region, however, is recording the fastest growth due to government initiatives and an increase in accessible treatment alternatives[4].

Challenges and Opportunities

One of the challenges for BAFIERTAM is the limited dosage level, which requires patients to take twice the quantity to achieve the same effect as other drugs. However, this can also be seen as an opportunity to differentiate the drug based on its unique pharmacokinetic profile and minimal side effects[3].

"Given the enormous differentials between AWPs and WACs for generic Tecfidera, unless Plans obtain extremely steep discounts off AWP from their PBMs for generic Tecfidera — of as much as AWP-96% — PBMs can invoice Plans and make an enormous “profit spread” on every generic script dispensed." - National Prescription Coverage Coalition[3]

Key Takeaways

• Market Growth: The global MS drugs market is expected to grow significantly, with BAFIERTAM benefiting from the increasing demand for oral medications.
• Pricing Dynamics: The drug's pricing is influenced by broader market trends, including significant drops in WAC for similar generic drugs.
• Patient Support: BAFIERTAM offers various patient support programs to enhance access and affordability.
• Regulatory Environment: Favorable regulatory conditions, such as the FDA's GDUFA, support the approval and availability of MS treatments.
• Geographical Impact: North America and the Asia Pacific region are key markets, with the latter showing the fastest growth.

FAQs

1. What is BAFIERTAM used for? BAFIERTAM is used as a treatment for multiple sclerosis (MS).

2. How is BAFIERTAM administered? BAFIERTAM is administered orally.

3. What support programs are available for BAFIERTAM patients? Patients can enroll in the $0 Copay Program, the QuickStart Program, and the Bridge Support Program to help reduce treatment costs and ensure therapy continuity.

4. How does BAFIERTAM compare to other MS drugs in terms of side effects? BAFIERTAM is known for its minimal side effects due to its slow and steady release in the body.

5. What are the key drivers of the MS drugs market growth? The market growth is driven by increased funding for MS research, approvals of new drugs, and patient preference for oral medications.

Sources

1. Emergen Research - Multiple Sclerosis Drugs Market Size, Share | Industry Forecast by ...
2. Nevada Medicaid - Nevada Medicaid Drug Use Review Board Meeting
3. National Prescription Coverage Coalition - Recent MS Drug Developments Demonstrate Plans Should Obtain Customized Formularies ASAP
4. GlobeNewswire - Multiple Sclerosis Market Set to Reach USD 33.57 Billion by 2032
5. Banner Patient Support Services - BAFIERTAM® Copay Assistance | Banner Patient Support Services