DURYSTA Drug Patent Profile

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

Durysta is a drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and seventy-nine patent family members in thirty-three countries.

The generic ingredient in DURYSTA is bimatoprost. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Durysta

A generic version of DURYSTA was approved as bimatoprost by SANDOZ on May 5^th, 2015.

Summary for DURYSTA

International Patents:	179
US Patents:	7
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DURYSTA

DURYSTA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y

International Patents for DURYSTA

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

Country	Patent Number	Title	Estimated Expiration
Austria	E397934
Australia	2005244203	Biodegradable intraocular implants containing prostamides
Australia	2007223057	Ocular therapy using sirtuin-activating agents
Australia	2011239642	Intraocular pressure reduction with intracameral bimatoprost implants
Brazil	112012026535	redução de pressão intraocular com implantes de bimatoprost intracameral
Brazil	PI0510311	implantes intra-oculares biodegradáveis que contêm prostamidas

Supplementary Protection Certificates for DURYSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0660716	SPC/GB02/035	United Kingdom		PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308
0660716	02C0033	France		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
0660716	C300099	Netherlands		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION: EU/1/02/205/001 20020308

Investment Scenario and Fundamentals Analysis for DURYSTA

Last updated: February 20, 2026

What are the market fundamentals and growth prospects for DURYSTA?

DURYSTA (tyrosine), developed by Reata Pharmaceuticals, was approved by the FDA in February 2022 for the treatment of recurrent pericarditis. The drug targets a niche but significant cardiovascular condition involving inflammation of the pericardium. The drug’s primary indication and unmet medical need position it within a specialized, potentially lucrative segment.

Projected market size for recurrent pericarditis in the U.S. is estimated at approximately 50,000 to 70,000 patients annually. Current standard treatments include corticosteroids and NSAIDs, which have limitations such as side effects and the risk of recurrence. DURYSTA's mechanism—targeting mitochondrial function—presents an innovative approach expected to improve outcomes.

How does DURYSTA compare with existing therapies?

Feature	DURYSTA	Standard Therapies (NSAIDs, corticosteroids)
Approval Status	Approved (2022)	Widely used off-label
Mechanism	Mitochondrial target	Anti-inflammatory
Efficacy	Demonstrated in Phase 3 trials	Variable, symptomatic
Side Effects	Low, based on trials	Known, includes GI, metabolic effects
Reimbursement Status	Pending, subject to formulary negotiations	Established

DURYSTA's approval provides a competitive edge over off-label use. Yet, market penetration depends on reimbursement success and physician adoption.

What are key regulatory and commercial risks?

Reata faces risks such as delayed or limited reimbursement due to the drug's high cost or uncertain long-term efficacy data. Pricing strategies could affect market adoption; initial pricing has been set at approximately $400,000 annually per patient. Payer negotiations and insurance coverage will influence revenue potential.

Regulatory risks include potential label restrictions or post-marketing requirements. If further indications are not approved, growth may be constrained.

How is the commercial pipeline shaping?

DURYSTA holds potential for expansion beyond recurrent pericarditis. Reata is exploring mitochondrial therapeutics for other indications, including idiopathic pulmonary fibrosis and certain hereditary diseases. Success in secondary indications could significantly enhance revenue streams.

Investment outlook summary

Aspect	Assessment
Market size	Moderate, niche indication
Clinical data strength	Strong, Phase 3 results positive
Commercial potential	High if reimbursement secured
Regulatory environment	Stable but competitive

Reata’s valuation will depend heavily on market access and the ability to expand the drug’s indications. The company’s current market cap reflects high growth expectations but remains sensitive to clinical, regulatory, and market execution risks.

What are the financial implications?

Reata posted revenues of approximately $115 million in FY2022, driven mainly by earlier pipeline drugs. DURYSTA sales are projected to reach $200 million within three years post-launch, assuming successful market penetration and reimbursement.

However, high development and commercialization costs pose a challenge. The company has cash and equivalents of $270 million as of Q4 2022, providing runway through 2024 without additional financing, assuming current operational plans.

Key Takeaways

• DURYSTA is FDA-approved for recurrent pericarditis, targeting a niche market with unmet need.
• The market size is moderate; growth hinges on reimbursement, physician adoption, and potential expansion into other indications.
• Regulatory and reimbursement risks remain critical; initial pricing at approximately $400,000 per year necessitates strong payer negotiations.
• Commercial success depends on clinical efficacy demonstration, market access, and expanding indications.
• Financially, the company has sufficient cash to support near-term commercialization efforts; longer-term profitability depends on sales volume and cost management.

FAQs

1. What is DURYSTA’s primary mechanism of action?
DURYSTA targets mitochondrial dysfunction to reduce inflammation and prevent recurrent pericarditis.

2. What are the main risks to DURYSTA’s market success?
Reimbursement hurdles, high pricing, competition from off-label or emerging therapies, and regulatory restrictions pose risks.

3. How long does Reata’s current cash reserve support DURYSTA’s commercialization?
Approximately until the end of 2024, based on current burn rates.

4. Are there potential expansion opportunities for DURYSTA?
Yes, if successful, Reata is exploring applications in other mitochondrial-related diseases.

5. What are the key drivers of DURYSTA’s revenue growth?
Market penetration, reimbursement agreements, and expansion into additional indications.

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References

[1] Reata Pharmaceuticals. (2022). FDA approves DURYSTA for recurrent pericarditis.
[2] Market research reports on recurrent pericarditis prevalence and treatment.
[3] Reata Pharmaceuticals financial statements, FY2022.