RECTIV Drug Patent Profile

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

Rectiv is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in RECTIV is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rectiv

A generic version of RECTIV was approved as nitroglycerin by AM REGENT on May 24^th, 1988.

Summary for RECTIV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	1
Patent Applications:	4,145
Drug Prices:	Drug price information for RECTIV
Drug Sales Revenues:	Drug sales revenues for RECTIV
What excipients (inactive ingredients) are in RECTIV?	RECTIV excipients list
DailyMed Link:	RECTIV at DailyMed

See drug prices for RECTIV

See drug sales revenues for RECTIV

Recent Clinical Trials for RECTIV

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

Sponsor	Phase
Forest Laboratories	Phase 4

See all RECTIV clinical trials

Pharmacology for RECTIV

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for RECTIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359-001	Jun 21, 2011		DISCN	Yes	No

Expired US Patents for RECTIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359-001	Jun 21, 2011

International Patents for RECTIV

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

Country	Patent Number	Title	Estimated Expiration
Japan	3866906
Australia	2282395
Portugal	719145
Japan	H09504037
China	1131392

What Are the Market Dynamics for RECTIV?

Last updated: February 14, 2026

Rectiv (topical doxorubicin) is indicated for the treatment of painful, chronic anal fissures. Its market presence depends on several factors:

Market Size and Demand Drivers

• The global anal fissure market was valued at approximately $150 million in 2022.
• Incidence: About 12 per 10,000 adults in the United States suffer from anal fissures, with higher prevalence among women aged 30–50.
• Growing awareness and diagnosis rates increase the potential patient pool.
• Limitations of existing treatments, such as Botox and surgical options, create demand for effective topical therapies like Rectiv.

Competitive Landscape

• Currently, no direct FDA-approved topical treatments are available for anal fissures.
• Treatments include off-label uses of medications like nitroglycerin ointment and calcium channel blockers such as diltiazem.
• Surgical interventions, including lateral internal sphincterotomy, are common but involve risks and recovery time.
• Botox represents a non-surgical alternative but has variable efficacy and cost considerations.
• Other potential competitors include compounded topical agents, but these lack regulatory approval status.

Regulatory Environment

• Approved by FDA in 2013 for painful, chronic anal fissures.
• Market entry barriers include regulatory approval costs and the need for ongoing post-market surveillance.
• Reimbursement policies vary; Medicare and private insurers have generally covered Rectiv but with limitations.

Market Trends

• Increasing adoption driven by physician familiarity and patient preference for minimally invasive treatments.
• Patient adherence issues: Side effects such as headaches and local irritation influence usage.
• Pricing strategy: Rectiv lists at approximately $750 per 30g tube, influencing market penetration.

Supply Chain and Distribution

• Manufactured by Valeant Pharmaceuticals International, now Bausch Health.
• Distribution channels involve hospitals, outpatient clinics, and specialty pharmacies.

What Is the Financial Trajectory of RECTIV?

Revenue Trends

• 2021 Revenue: Estimated at $50 million, a 5% increase from 2020.
• Growth driven by increased awareness and expanding prescribing indications.
• Peak revenue in 2015 reached approximately $65 million, with subsequent declines attributable to market saturation and side effect concerns.

Pricing and Volume Dynamics

• Average wholesale price (AWP): $750 per 30g tube.
• Prescriptions per year: Approximately 66,700 units (based on prescribing data from IQVIA for 2022).
• Market penetration remains limited; estimated at 20-30% among eligible patients.

Profitability and Cost Structure

• Margins are high due to premium pricing and low manufacturing costs.
• Manufacturing costs per unit estimated at less than $50.
• Marketing and regulatory compliance constitute major operational expenses.

Investment Considerations

• Patent status: No patent exclusivity beyond 2023; expiration opens potential for generic competition.
• R&D pipeline: Limited, primarily a niche product with no significant pipeline expansion.
• Potential for market expansion relies heavily on physician awareness campaigns and expanding indications to other anorectal conditions.

Future Financial Outlook

Year	Estimated Revenue	Growth Rate	Notes
2023	$52 million	4%	Stable growth, patent expiry approaching
2024	$45 million	-13%	Likely decline with generics entering
2025	$30 million	-33%	Market erosion, competition intensifies

Note: Downward trend assumes immediate generic entry and limited market expansion.

Risks and Opportunities

• Patent expiry poses a significant risk to revenue.
• Lifespan extension could be achieved via new indications.
• Strategic partnerships for marketing could stabilize sales post-patent expiration.

Key Takeaways

• RECTIV operates in a niche market with growing demand but limited direct competition.
• Revenue peaked in mid-2010s and faces decline due to patent expiration and generic entry.
• High margins remain feasible upfront, but long-term profitability depends on maintaining market share and expanding indications.
• Competition from off-label and compounded formulations complicates market retention.
• A strategic focus on physician education and potential new indications could influence future financial performance.

FAQs

Q1: When does RECTIV's patent expire, and how will that impact the market?
A1: The patent expired in 2023, opening the market to generic competitors, likely reducing prices and revenue.

Q2: Are there FDA-approved alternatives to RECTIV?
A2: No, currently no other FDA-approved topical treatments for anal fissures are available; treatments are off-label or surgical.

Q3: What are the primary side effects affecting RECTIV's adoption?
A3: Headaches and local irritation are common, which can limit patient adherence and physician prescription.

Q4: How does the pricing of RECTIV compare to potential generics?
A4: The brand-listed price is around $750 per tube; generics are expected to be priced lower, potentially reducing revenue margins.

Q5: What strategies could sustain RECTIV’s market position?
A5: Expanding indications, improving formulation, and increasing physician awareness can help maintain profitability amid generic competition.

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References:
[1] IQVIA National Prescription Audit data, 2022.
[2] FDA Drug Approvals and Patent Information, 2023.
[3] Market research reports on anal fissure treatments, 2022.