RIZAFILM Drug Patent Profile

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

Rizafilm is a drug marketed by Gensco and is included in one NDA. There is one patent protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in RIZAFILM is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rizafilm

A generic version of RIZAFILM was approved as rizatriptan benzoate by AUROBINDO PHARMA LTD on December 31^st, 2012.

Summary for RIZAFILM

International Patents:	20
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in RIZAFILM?	RIZAFILM excipients list
DailyMed Link:	RIZAFILM at DailyMed

Pharmacology for RIZAFILM

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

US Patents and Regulatory Information for RIZAFILM

RIZAFILM is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gensco	RIZAFILM	rizatriptan benzoate	FILM;ORAL	205394-001	Apr 14, 2023		DISCN	Yes	No			Y	Y

International Patents for RIZAFILM

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

Country	Patent Number	Title	Estimated Expiration
Japan	2016527262	界面活性剤および多価アルコールを有さず直ちに湿潤可能な経口フィルム剤形
Hong Kong	1222796	不含表面活性劑或多元醇的即時可濕性口服薄膜劑型 (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL)
Canada	2919442	FORME POSOLOGIQUE ORALE EN FILM INSTANTANEMENT MOUILLABLE SANS TENSIOACTIF NI POLYOL (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL)
Russian Federation	2016106907	МГНОВЕННО СМАЧИВАЮЩАЯСЯ ПЕРОРАЛЬНАЯ ПЛЕНОЧНАЯ ЛЕКАРСТВЕННАЯ ФОРМА БЕЗ ПОВЕРХНОСТНО-АКТИВНОГО ВЕЩЕСТВА ИЛИ ПОЛИСПИРТА
Spain	2706481
South Korea	20160089335	계면활성제 또는 폴리알콜을 포함하지 않은 즉각적 습윤성의 경구용 필름 제형 (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL)
Chile	2016000160	Pelicula oral que comprende hidroxipropilcelulosa sola o combinada con polivinilpirrolidona, al menos un copolímero de vinilpirrolidona, dioxido de titanio, en donde la relación del copolímero de vinilpirrolidona con el dioxido de titanio es de 3 es a 1 a 5 es a 1, y rizatriptán, zolmitriptán, alprazolam, diazepam o lorazepam, como principio activo.

Supplementary Protection Certificates for RIZAFILM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0497512	9891028-4	Sweden		PRODUCT NAME: RIZATRIPTAN, N.N-DIMETYL-2-(5-(1, 2, 4-TRIAZOL-1-YLMETYL)-1H-INDOL-3-YL)ET)-1H-I, EVENTUELLT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT, SPECIELLT DA RIZATRIPTANBENSOAT
0497512	99C0011	Belgium		PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211
0497512	98C0037	France		PRODUCT NAME: RIZATRIPTAN BENZOATE; REGISTRATION NO/DATE IN FRANCE: NL 23 695 DU 19980817; REGISTRATION NO/DATE AT EEC: 21 815 DU 19980211
0497512	SPC/GB98/035	United Kingdom		PRODUCT NAME: RIZATRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY RIZATRIPTAN BENZOATE; REGISTERED: NL 21815 19980211; NL 21816 19980211; NL 21817 19980211; NL 21818 19980211; UK 00025/0369 19980624; UK 00025/0370 19980624; UK 00025/0371 19980624; UK 00025/0372 19980624
0497512	28/1998	Austria		PRODUCT NAME: RIZATRIPTAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE RIZATRIPTANBENZOAT; NAT. REGISTRATION NO/DATE: 1-22636 - 1-22639 19980709; FIRST REGISTRATION: NL 21815 - 21818 19980211
0497512	C980019	Netherlands		PRODUCT NAME: RIZATRIPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZOND ER RIZATRIPTAN-BENZOAAT; REGISTRATION NO/DATE: RVG 21815 - RVG 21818 19980211

RIZAFILM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RIZAFILM

Introduction to RIZAFILM

RIZAFILM, developed by IntelGenx, is a revolutionary oral thin film formulation of rizatriptan benzoate, the active ingredient in Merck & Co.'s Maxalt. This innovative product has been approved by the FDA for the treatment of acute migraines and is set to disrupt the migraine treatment market with its unique delivery system[1][3][4].

Market Size and Growth Potential

The global migraine drugs market is substantial and growing rapidly. Valued at nearly $3 billion in 2021, it is expected to reach nearly $11 billion by 2030, representing a compound annual growth rate of 15.6%. This growth is driven by the increasing prevalence of migraines, with approximately 39 million Americans, or 12% of the population, suffering from this condition[1][3][4].

Competitive Advantage

RIZAFILM offers several competitive advantages that position it favorably in the market:

• Convenience and Ease of Use: Unlike traditional tablets, RIZAFILM does not require water for administration, making it highly convenient for patients, especially those experiencing migraine-related nausea or difficulty swallowing[1][3][4].
• Rapid Relief: It is the fastest triptan on the market, providing quick relief from migraine symptoms, including pain, nausea, photophobia, and phonophobia[1][3].
• Innovative Technology: Developed using IntelGenx’s proprietary VersaFilm technology, RIZAFILM is the first oral thin film for the treatment of acute migraines available in the U.S.[1][3][4].

Commercialization and Launch

Gensco Pharma, in partnership with IntelGenx, is preparing to commercially launch RIZAFILM across the United States. The launch is anticipated for Q1-2024, with Gensco Pharma handling the commercialization and funding for expanded indications, including a 5mg pediatric dose[3][4].

Financial Trajectory

Revenue Projections and Milestones

IntelGenx has received the first purchase order for RIZAFILM from Gensco Pharma, with shipments expected in Q2 2024. This marks a significant milestone for the company, indicating the start of commercial revenue generation from this product[2].

• Financial Performance: In Q4 2023, IntelGenx reported a total revenue of $426,000, an increase of 146% over the same period in the previous year, primarily due to an increase in R&D revenue. The company also reported an operating loss of $2 million, down from $2.5 million in Q4 2022[2].
• Future Growth: With the launch of RIZAFILM, IntelGenx anticipates entering a phase of rapid growth. The company plans to support this growth through a Reg A offering to raise funds, which will also be used to advance other products in the pipeline and invest in the CDMO (Contract Development and Manufacturing Organization) business model[2].

Partnerships and Licensing Agreements

IntelGenx has a definitive licensing, development, and supply agreement with Gensco Pharma for the exclusive commercialization of RIZAFILM in the United States. Under this agreement, IntelGenx is entitled to receive royalty payments based on net profits of RIZAFILM and pre-specified payments upon achieving certain regulatory and commercial milestones[3][4].

Patent Protection and Market Exclusivity

RIZAFILM is patent protected until July 2034, which provides a significant period of market exclusivity. This protection is listed in the Orange Book, ensuring that IntelGenx and Gensco Pharma can capitalize on the product’s unique advantages without immediate generic competition[1][3][4].

Challenges and Uncertainties

While RIZAFILM presents a promising market opportunity, there are several challenges and uncertainties to consider:

• Insurance Coverage: There is uncertainty regarding whether insurers and payers will cover RIZAFILM. However, IntelGenx believes the product’s advantages will make a strong case for coverage[1].
• European Commercialization: IntelGenx is currently seeking a new commercial partner in Europe after no progress with Exeltis in Spain, which could impact the product’s global reach[2].

Industry Expert Insights

Andre Godin, President and CFO of IntelGenx, highlighted the advantages of RIZAFILM, stating, "RIZAFILM has a number of advantages that make it a compelling treatment option for migraine sufferers. It’s the fastest triptan on the market and is also convenient. It’s easy to carry and unlike a tablet, does not require water."[1]

Dwight Gorham, CEO of IntelGenx, emphasized the strategic partnership with Gensco Pharma, saying, "We believe this exciting partnership with Gensco offers a tremendous opportunity to commercialize RIZAFILM in the world’s largest migraine market."[4]

Patient Adoption and Market Reception

A patient survey indicated that 69% of respondents would discuss switching their current migraine therapy to RIZAFILM with their doctor, suggesting strong potential for patient adoption. The ease of use and rapid relief provided by RIZAFILM are expected to drive significant market reception[4].

Key Takeaways

• Market Growth: The global migraine drugs market is expected to grow significantly, reaching nearly $11 billion by 2030.
• Competitive Advantage: RIZAFILM offers convenience, rapid relief, and innovative technology.
• Commercialization: The product is set to launch in the U.S. in Q1-2024, with Gensco Pharma handling commercialization.
• Financial Trajectory: IntelGenx anticipates rapid growth with the launch of RIZAFILM, supported by a Reg A offering.
• Challenges: Uncertainty regarding insurance coverage and European commercialization.

FAQs

Q: What is RIZAFILM and how does it differ from traditional migraine treatments? A: RIZAFILM is an oral thin film formulation of rizatriptan benzoate, offering convenience and rapid relief without the need for water.

Q: When is RIZAFILM expected to be launched in the U.S.? A: RIZAFILM is anticipated to be launched in the U.S. in Q1-2024.

Q: Who is responsible for the commercialization of RIZAFILM in the U.S.? A: Gensco Pharma is responsible for the commercialization of RIZAFILM in the U.S.

Q: What are the key advantages of RIZAFILM over other migraine treatments? A: RIZAFILM offers convenience, rapid relief, and is well-suited for patients with migraine-related nausea or difficulty swallowing.

Q: Is RIZAFILM protected by patents? A: Yes, RIZAFILM is patent protected until July 2034.

Cited Sources

1. Drug Topics: "Another Possible Migraine Treatment Approved by FDA"
2. Investing.com: "Earnings call: IntelGenx highlights RIZAFILM launch, seeks new EU partner"
3. IntelGenx: "IntelGenx Announces FDA Approval of RIZAFILM® for the Treatment of Acute Migraine"
4. Gensco Pharma: "Gensco® Pharma Announces RizaFilm® Commercialization Update in the United States"