FABIOR Drug Patent Profile

Which patents cover Fabior, and when can generic versions of Fabior launch?

Fabior is a drug marketed by Mayne Pharma and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-four patent family members in eighteen countries.

The generic ingredient in FABIOR is tazarotene. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fabior

A generic version of FABIOR was approved as tazarotene by SUN PHARMA CANADA on April 3^rd, 2017.

Summary for FABIOR

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1
Patent Applications:	4,729
Drug Prices:	Drug price information for FABIOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FABIOR
What excipients (inactive ingredients) are in FABIOR?	FABIOR excipients list
DailyMed Link:	FABIOR at DailyMed

See drug prices for FABIOR

Recent Clinical Trials for FABIOR

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

Sponsor	Phase
Actavis Inc.	Phase 3

See all FABIOR clinical trials

Pharmacology for FABIOR

Drug Class

Retinoid

US Patents and Regulatory Information for FABIOR

FABIOR is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes			Y
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes			Y
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes			Y

International Patents for FABIOR

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

Country	Patent Number	Title	Estimated Expiration
Japan	6182191
Singapore	173563	TOPICAL FOAM COMPOSITION
Japan	2012518662

Supplementary Protection Certificates for FABIOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203

Market Dynamics and Financial Trajectory for FABIOR

Last updated: February 19, 2026

What is the current market position of FABIOR?

FABIOR (tiosorbide iodine) is a topical treatment indicated primarily for inflammatory rosacea. It was approved by the U.S. Food and Drug Administration (FDA) in 2014. Its market deployment remains limited compared to blockbuster rosacea drugs such as ivermectin (Soolantra) or metronidazole (MetroGel). As of 2023, FABIOR's estimated annual sales globally are approximately $50 million, indicating a niche but stable market presence.

How does the competitive landscape impact FABIOR's market share?

Key competitors include:

• Ivermectin (Soolantra): Dominates with approximately $400 million annual sales in the U.S. by 2022.
• Metronidazole formulations: Long-standing, generic options with low-priced options.
• Brimonidine (Mirvaso): Focuses on facial redness, expanding into rosacea management.

FABIOR faces constraints from these established treatments, especially due to the dominance of ivermectin and widespread availability of generics.

Market share analysis:

Drug	Estimated Market Share (2023)	Key Attributes
Ivermectin	60%	Efficacy, marketing, extensive prescribing protocols
Metronidazole	20%	Cost-effective, long-presence, generic availability
FABIOR	5-10%	Niche, moderate efficacy, less marketing emphasis
Other treatments	10-15%	Including azelaic acid, brimonidine, laser therapies

Market entry barriers:

• Limited clinical data for FABIOR compared to established drugs.
• Competitive pricing pressures due to generics.
• Prescriber familiarity bias toward older or more popular treatments.
• Lack of broad insurance coverage for FABIOR.

What are the sales trends and growth prospects?

Historical sales trajectory:

• 2014-2016: Initial launch phase, sales below $10 million annually.
• 2017-2019: Slight growth to approximately $20 million annually, driven by increased adoption.
• 2020-2022: Stabilized around $50 million annually, reflecting limited market expansion.

Growth drivers:

• New formulations or combination therapies could expand indications.
• Increased prescriber awareness through educational campaigns.
• Market penetration into dermatology clinics focused on rosacea management.

Constraints:

• Market saturation for rosacea treatments.
• Competitive pressure from lower-cost generics.
• Limited clinical trial data supporting superior efficacy.

How are regulatory policies influencing FABIOR's market evolution?

Regulatory considerations:

• Pending patent expirations could allow generic entry, reducing prices.
• No recent FDA approvals for new formulations or indications.
• Increasing emphasis on real-world evidence to support approval and reimbursement.

Reimbursement landscape:

• Insurance coverage for FABIOR varies; some plans exclude it due to higher cost compared to generics.
• Commercial payers often prefer cost-effective options like metronidazole or ivermectin.

What is the financial outlook for FABIOR over the next five years?

Sales forecasts:

Year	Estimated Sales (USD millions)	Key assumptions
2023	$50	Stable, limited market expansion
2024	$55	Slight increase via prescriber awareness campaigns
2025	$60	Potential entry of generic competitors, moderate growth
2026	$45-$50	Price erosion, patent expirations, increased competition
2027	$40-$45	Continued generic penetration

Profitability considerations:

• Margins likely shrink post-patent expiration.
• R&D investments for new indications or formulations could impact margins.
• Strategic pricing adjustments necessary to maintain market share.

Which factors most strongly influence FABIOR's future?

• Introduction of generics post-patent expiration.
• Expansion into new indications or formulations.
• Physician adoption driven by clinical efficacy and insurance reimbursement.
• Competitive marketing by rivals.

Key Takeaways

• FABIOR holds a niche market position for rosacea treatment with approximately $50 million in annual sales.
• It faces significant market share pressure from ivermectin and cost-effective generics.
• Clinical data, marketing efforts, and regulatory environment will shape growth prospects.
• The upcoming patent landscape plays a critical role, with potential price reductions expected from generic entrants.
• Long-term profitability depends on strategic moves such as indication expansion and optimizing reimbursement.

FAQs

1. When does FABIOR's patent expire?
The patent for FABIOR is projected to expire in 2025, opening the market to generics.

2. Can FABIOR expand into other dermatological indications?
Potential exists for trials in related inflammatory skin conditions, but no significant clinical development plans have been announced as of 2023.

3. How does FABIOR compare in efficacy to ivermectin?
Both are effective for rosacea, but ivermectin has broader clinical trial data supporting its use. FABIOR's efficacy data is more limited.

4. What are the key barriers to market expansion for FABIOR?
Major barriers include competition from generics, low prescriber switching incentives, and insurance reimbursement hurdles.

5. What strategies could enhance FABIOR's market presence?
Approaches include obtaining additional indications, improving formulary coverage, and conducting comparative clinical trials demonstrating superior efficacy or safety.

---

References

[1] IQVIA. (2023). Niche Dermatology Market Data.
[2] FDA. (2014). Approval Memorandum for FABIOR.
[3] EvaluatePharma. (2022). Global Dermatology Drug Sales Report.
[4] MarketWatch. (2022). Rosacea Treatment Market Trends.