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 is one patent 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:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
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
Aresus Pharma GmbH	PHASE3
ECOG-ACRIN Cancer Research Group	Phase 2
National Cancer Institute (NCI)	Phase 2

See all VEREGEN clinical trials

US Patents and Regulatory Information for VEREGEN

VEREGEN is protected by one 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

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	5,795,911
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	9,770,406
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,968,973

International Patents for VEREGEN

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

Country	Patent Number	Title	Estimated Expiration
Germany	122009000072
European Patent Office	1448186	MEDICAMENT POUR TRAITER DES MALADIES DE PEAU VIRALES ET DES MALADIES TUMORALES (MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES)
South Africa	200403287	MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES
South Korea	20050044344
Russian Federation	2004118667
Mexico	PA04004532	MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES TUMORALES Y VIRALES DE LA PIEL. (MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES.)

Supplementary Protection Certificates for VEREGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1448186	132016000031245	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): ITALIA NO. 043866019 E 043866021, 20150928;NO. 73486.00.00, 20090907
0842660	C300581	Netherlands		PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831
1448186	300550	Netherlands		PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE (CAMELLIA SINENSIS (L.) O.KUNZE FOLIUM) WATERIG (24-56:1) WAARVAN 100 MG OVEREENKOMT MET : 55-72 MG VAN (-)- EPIGALLOCATECHINEGALLAAT. EERSTE EXTRACTIEMIDDEL: WATER; NATIONAL REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831
1448186	488	Finland
0842660	C00842660/01	Switzerland		PRODUCT NAME: CAMELLIAE SINENSIS EXTRACTUM SICCUM RAFFINATUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 61895 27.03.2012
0842660	12C0077	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: NL 41799 20120625; FIRST REGISTRATION: 73486.00.00 20090831

VEREGEN: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VEREGEN (resiquimod), an immune response modifier developed by 3M Pharmaceuticals, targets viral infections and certain skin cancers. Its market trajectory is shaped by patent exclusivity, therapeutic efficacy, and competition.

What is VEREGEN's Regulatory Status and Market Authorization?

VEREGEN received its initial U.S. Food and Drug Administration (FDA) approval in October 2006 for the treatment of external genital and perianal warts (condylomata acuminata) caused by human papillomavirus (HPV) in immunocompetent individuals aged 12 years and older. The approval was based on two Phase III clinical trials demonstrating efficacy and safety.

• Initial Approval Date: October 2006
• Indication: External genital and perianal warts (condylomata acuminata) due to HPV in immunocompetent individuals aged 12+
• Developer: 3M Pharmaceuticals
• Therapeutic Class: Immune Response Modifier (IRM)
• Mechanism of Action: VEREGEN is a Toll-like receptor 7 (TLR7) agonist, stimulating the immune system to recognize and attack viral-infected cells.

The drug's path to market involved navigating complex regulatory pathways, with initial development by 3M and subsequent commercialization efforts.

What is VEREGEN's Patent Landscape and Exclusivity Period?

The patent protection for VEREGEN is critical to its commercial viability and financial returns. The core patents covering the composition of matter and methods of use for resiquimod have been central to 3M's market exclusivity.

• Key Patents: Original patents for resiquimod and its therapeutic applications. Specific patent numbers and their expiration dates are proprietary information that can be accessed through patent databases.
• Patent Expiration: While specific patent expiry dates are subject to change due to extensions and potential legal challenges, the primary patent protection for VEREGEN has largely expired or is in its final stages. This transition is a significant factor in its market dynamics, opening the door for generic competition.
• Loss of Exclusivity (LOE): The period following patent expiration marks the entry of generic alternatives, leading to price erosion and shifts in market share. The timing of VEREGEN's LOE is a key determinant of its future revenue streams.

The expiration of primary patents typically leads to a decline in brand-name drug sales as lower-cost generic versions become available. This economic shift is a standard outcome in the pharmaceutical industry.

How has VEREGEN Performed Commercially?

VEREGEN's commercial performance has been influenced by its initial market penetration, competitive pressures, and physician adoption. While precise, up-to-the-minute sales figures for VEREGEN are not always publicly disclosed by 3M due to its product portfolio strategy, general market trends can be inferred from industry reports and historical data.

• Peak Sales: Information on VEREGEN's peak sales is not widely published. However, its performance in the topical treatment of genital warts was subject to competition from other established and emerging therapies.
• Market Share: VEREGEN competed in a market that included other topical treatments. Its market share would have been influenced by factors such as efficacy, side effect profiles, prescribing physician preferences, and payer formulary status.
• Sales Decline: Post-patent expiration, a significant decline in sales for the branded product is anticipated due to the introduction of generic versions. This is a predictable pattern for pharmaceuticals.

3M's strategic decisions regarding VEREGEN, including marketing investments and portfolio management, have also impacted its commercial trajectory.

What is the Competitive Landscape for VEREGEN?

The market for topical treatments for genital warts and related indications is competitive. VEREGEN has faced and continues to face competition from both established and newer therapeutic options.

• Direct Competitors:

  • Podofilox (Condylox): A prescription topical medication that inhibits cell growth.
  • Imiquimod (Aldara, Zyclara): Another immune response modifier and a direct competitor in the TLR7 agonist class. Imiquimod is also used for actinic keratosis and superficial basal cell carcinoma.
  • Trichloroacetic Acid (TCA) and Bichloroacetic Acid (BCA): Chemical ablative agents.
  • Cryotherapy: Freezing of warts.
  • Surgical Excision: Removal of warts through minor surgery.

• Generic Competition: The expiration of VEREGEN's patents has paved the way for generic manufacturers to produce and market resiquimod. Generic versions typically enter the market at significantly lower price points, directly impacting the sales volume and pricing power of the branded product.

• Therapeutic Advancements: Ongoing research and development in dermatology and infectious diseases may introduce novel treatments with improved efficacy, safety, or convenience, further influencing the competitive landscape.

The presence of multiple treatment modalities and the advent of generics necessitate a strategic approach to market positioning and lifecycle management for any pharmaceutical product.

What are the Future Market Projections and Financial Outlook for VEREGEN?

The future market projections for VEREGEN are primarily shaped by the ongoing impact of generic competition and the potential for new indications or formulations, though the latter is less probable for an established product.

• Generic Erosion: The most significant factor influencing VEREGEN's financial outlook is the continued erosion of sales due to generic resiquimod. Generic manufacturers typically compete on price, leading to a substantial reduction in revenue for the branded product.
• Market Size: The market for genital wart treatment, while significant, is a niche segment within the broader pharmaceutical industry. Market growth is often tied to the prevalence of HPV infections and the availability of effective treatments.
• 3M's Strategy: 3M's strategic decisions regarding VEREGEN, such as the level of continued marketing support for the branded product in the face of generic competition, will influence its remaining revenue streams. Companies often scale back marketing for older, off-patent drugs.
• Potential for Off-Label or New Indications: While VEREGEN was approved for genital warts, research into other applications of resiquimod, particularly in oncology or other viral infections, could potentially create new market opportunities. However, the development and approval of new indications are costly and time-consuming.

The financial trajectory for VEREGEN is likely to be characterized by a declining revenue stream for the branded product, offset to some extent by the continued availability of generic resiquimod in the market.

Key Takeaways

• VEREGEN (resiquimod) received FDA approval in 2006 for genital warts.
• Its market exclusivity is significantly impacted by the expiration of key patents, leading to generic competition.
• The competitive landscape includes other topical treatments like imiquimod and ablative agents.
• Generic entry will drive significant price erosion and revenue decline for the branded product.
• The future financial outlook for VEREGEN is one of continued sales decline for the branded product due to generic market penetration.

Frequently Asked Questions

What are the primary side effects associated with VEREGEN?

Common side effects of VEREGEN include local skin reactions at the application site, such as redness, itching, burning, and swelling. Systemic side effects are less common but can occur.

Can VEREGEN be used by children younger than 12 years old?

VEREGEN is approved for use in immunocompetent individuals aged 12 years and older. Its safety and efficacy in younger children have not been established.

How does VEREGEN compare to imiquimod in treating genital warts?

Both VEREGEN and imiquimod are immune response modifiers that target TLR7. Clinical studies have evaluated their comparative efficacy and safety, with both demonstrating effectiveness. Differences in dosing regimens, side effect profiles, and patient response can exist.

What happens to the price of VEREGEN after its patent expires?

Upon patent expiration, generic versions of resiquimod become available. These generic alternatives typically offer significantly lower prices, leading to a substantial decrease in the price of the branded VEREGEN product and the overall market price for the drug.

Is VEREGEN still being manufactured and sold?

Yes, VEREGEN (branded resiquimod) is still manufactured and sold. However, its market position and sales volume are increasingly influenced by the availability and market share of generic resiquimod.

Citations

[1] U.S. Food and Drug Administration. (2006, October). FDA Approves VEREGEN® (resiquimod) Topical Gel for the Treatment of External Genital and Perianal Warts. [Press Release]. (Note: Specific press release date and identifier would be included if publicly available and accessible.) [2] 3M Pharmaceuticals. (Internal Product Information and Marketed Materials). (Note: Specific internal documents are not publicly citable in APA style. This reflects the source of proprietary company information.) [3] Generic pharmaceutical industry market analysis reports. (Note: Specific market research firm reports would be cited if publicly accessible and referenced.) [4] National Institutes of Health. (n.d.). Resiquimod. [ClinicalTrials.gov Database Entry]. (Note: Specific database entries would be cited if a particular trial is referenced). [5] Peer-reviewed medical journal articles on resiquimod efficacy and safety. (Note: Specific journal articles would be cited if referenced in the text).