VEREGEN Drug Patent Profile

Which patents cover Veregen, and what generic alternatives are available?

Veregen is a drug marketed by Ani Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty countries.

The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sinecatechins profile page.

DrugPatentWatch^® Generic Entry Outlook for Veregen

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEREGEN

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Drug Prices:	Drug price information for VEREGEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEREGEN
What excipients (inactive ingredients) are in VEREGEN?	VEREGEN excipients list
DailyMed Link:	VEREGEN at DailyMed

See drug prices for VEREGEN

See drug sales revenues for VEREGEN

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

Constraining patent/regulatory exclusivity:

5,795,911

NDA:

021902

Dosage:

OINTMENT;TOPICAL

^*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 VEREGEN

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
ECOG-ACRIN Cancer Research Group	Phase 2
GTO Pharmaceutical, LLC	Phase 2

See all VEREGEN clinical trials

US Patents and Regulatory Information for VEREGEN

VEREGEN is protected by two US patents.

This potential generic entry date is based on patent 5,795,911.

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
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes	7,858,662		Y
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes	9,770,406		Y

Expired US Patents for VEREGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	10,434,059
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,968,973
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,795,911

International Patents for VEREGEN

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

Country	Patent Number	Title	Estimated Expiration
China	1185947
South Africa	200403287	MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES
Portugal	1448186
European Patent Office	2055300	Médicament comprenant du myristate d'isopropyle et une catéchine (Medicament comprising isopropylmyristate and a catechin)

Supplementary Protection Certificates for VEREGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1448186	12C0058	France		PRODUCT NAME: EXTRAIT SEC RAFFINE DE FEUILLE DE THE VERT (CAMELLIA SINENSIS (L.) O. KUNTZE) QUANTIFIE EN GALLATE D'(-)-EPIGALLOCATECHINE; NAT. REGISTRATION NO/DATE: NL41799 20120625; FIRST REGISTRATION: DE - 73186.00.00 20090831
1448186	CA 2012 00040	Denmark
2055300	132016000077885	Italy		PRODUCT NAME: ESTRATTO SECCO DI CAMELLIA SINENSIS (L.) O. KUNTZE FOLIUM (TE VERDE FOGLIE) CORRISPONDENTE A (-) - EPIGALLOCATECHINA GALLATO(VEREGEN 10% UNGUENTO); AUTHORISATION NUMBER(S) AND DATE(S): 043866019 - 43866021, 20150928;73486.00.00, 20090907
1448186	29/2010	Austria		PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908

Market Dynamics and Financial Trajectory for the Drug: Veregen

Introduction

Veregen, a topical ointment containing sinecatechins, is used for the local treatment of external genital and perianal warts (Condylomata acuminata). This article delves into the market dynamics and financial trajectory of Veregen, highlighting key transactions, market performance, and financial impacts on its parent company, Medigene AG.

Market Position and Competitors

Veregen is positioned as a first-line topical therapy for the treatment of external genital warts. A cost-effectiveness analysis reveals that Veregen is more economical and effective compared to its principal competitor, imiquimod (Aldara)[2].

• Cost-Effectiveness: Veregen has a lower average cost of treatment ($774) compared to imiquimod ($930). The cost per successful outcome is also lower for Veregen ($1,492) versus imiquimod ($2,289)[2].
• Market Share: The sale of Veregen rights in different regions has impacted its market share. For instance, the sale of US rights to Fougera Pharmaceuticals in 2017 significantly altered the revenue streams from Veregen[4].

Transactions and Rights Sales

Medigene AG has undergone several transactions involving the rights to Veregen, which have been pivotal in shaping its financial trajectory.

Sale of US Rights

In December 2017, Medigene sold the US rights for Veregen to Fougera Pharmaceuticals, Inc., a part of the Novartis group. This transaction marked a significant step in Medigene's transformation into a pure-play, clinical-stage immunotherapy company. The deal included the transfer of intellectual property, licenses, know-how, and the trademark, while Medigene retained the rights to supply the active pharmaceutical ingredient (API) to Fougera[4].

Sale of Remaining Rights

In 2019, Medigene sold its remaining rights to Veregen, along with the complete stock of the corresponding API, to Aresus Pharma GmbH. This sale completed Medigene's transition away from its non-core business and into a pure immunotherapy company. Medigene received up to approximately EUR 7.75 million from Aresus, with EUR 300,000 paid upfront and the balance to be received as annual revenue-based earn-out payments over the next ten years[1].

Financial Impact

The sales of Veregen rights have had a substantial financial impact on Medigene AG.

Revenue and EBITDA

• Revenue: The sale of US rights in 2017 led to an increase in Medigene's financial guidance for 2017, with expected revenues of EUR 10.5-11.5 million, up from the previous guidance of EUR 8-10 million[4].
• EBITDA: The transaction with Fougera also improved Medigene's EBITDA outlook, reducing the expected loss from EUR 16-18 million to EUR 14-15 million[4].
• 2019 Financials: The sale to Aresus Pharma in 2019 resulted in a non-cash effective loss of EUR 4-5 million for Medigene, which would be compensated by interest income as the payment period shortened[1].

Cash Utilization

The transactions have also affected Medigene's cash utilization. For instance, the 2017 sale to Fougera led to a revised cash utilization forecast of EUR 20-22 million, down from EUR 23-27 million[4].

Market Expansion and Development

Aresus Pharma, the new owner of Veregen rights, plans to invest in expanding Veregen into new indications and markets. The company's founders, Mr. Sven Schimansky-Wabra and Dr. Francisco Harrison, have a strong background in dermatology and clinical research, which is expected to drive further commercialization and clinical development of Veregen[1].

Regulatory and Clinical Aspects

Veregen's effectiveness and safety have been established through clinical trials. A two-stage decision model comparing Veregen with imiquimod highlighted Veregen's superior sustained clearance rates and lower treatment costs[2].

Conclusion on Market Dynamics

The market dynamics for Veregen have been shaped by strategic transactions that have transformed Medigene AG into a focused immunotherapy company. These transactions have optimized revenue streams, improved financial guidance, and ensured the continued development and commercialization of Veregen.

Key Takeaways

• Cost-Effectiveness: Veregen is more cost-effective than its competitor imiquimod.
• Transactions: Sales of US and global rights have significantly impacted Medigene's financial trajectory.
• Financial Impact: Improved revenue and EBITDA outlook following the transactions.
• Market Expansion: Aresus Pharma plans to expand Veregen into new indications and markets.
• Regulatory and Clinical: Veregen has demonstrated superior sustained clearance rates in clinical trials.

FAQs

What is Veregen used for?

Veregen is a topical ointment used for the local treatment of external genital and perianal warts (Condylomata acuminata).

Who are the current owners of Veregen rights?

The current owners of Veregen rights are Aresus Pharma GmbH, who acquired the rights from Medigene AG in 2019.

How does Veregen compare to imiquimod in terms of cost and effectiveness?

Veregen is more cost-effective and has a higher sustained clearance rate compared to imiquimod[2].

What was the financial impact of the sale of US rights to Fougera Pharmaceuticals?

The sale led to an increase in Medigene's revenue guidance and a reduction in the expected EBITDA loss for 2017[4].

What are the future plans for Veregen under Aresus Pharma?

Aresus Pharma plans to invest in expanding Veregen into new indications and markets, leveraging the founders' expertise in dermatology and clinical research[1].

Sources

1. Medigene AG: Medigene sells remaining rights and inventories of Veregen® to Aresus Pharma GmbH.
2. PubMed: A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts.
3. Medigene AG: Annual Report 2019.
4. BioSpace: Medigene Sells U.S.-Rights for Veregen and Raises Financial Guidance.

Last updated: 2024-12-16