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SIMBRINZA Drug Patent Profile

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

Simbrinza is a drug marketed by Alcon Labs Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SIMBRINZA is brimonidine tartrate; brinzolamide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; brinzolamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Simbrinza

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 17, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SIMBRINZA

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	9
Patent Applications:	8
Drug Prices:	Drug price information for SIMBRINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SIMBRINZA
What excipients (inactive ingredients) are in SIMBRINZA?	SIMBRINZA excipients list
DailyMed Link:	SIMBRINZA at DailyMed

See drug prices for SIMBRINZA

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

Constraining patent/regulatory exclusivity:

9,421,265

NDA:

204251

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*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 SIMBRINZA

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

Sponsor	Phase
Perrigo Company	Phase 3
Novartis Pharmaceuticals	Phase 4
Cornerstone Health Care, PA	Phase 4

See all SIMBRINZA clinical trials

Pharmacology for SIMBRINZA

Drug Class	Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Carbonic Anhydrase Inhibitors

Paragraph IV (Patent) Challenges for SIMBRINZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SIMBRINZA	Ophthalmic Suspension	brimonidine tartrate; brinzolamide	1%/0.2%	204251	1	2022-08-01

US Patents and Regulatory Information for SIMBRINZA

SIMBRINZA is protected by two US patents.

This potential generic entry date is based on patent 9,421,265.

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
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	9,044,484		Y
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	9,421,265		Y

Expired US Patents for SIMBRINZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013	6,316,441

EU/EMA Drug Approvals for SIMBRINZA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Simbrinza	brinzolamide, brimonidine tartrate	EMEA/H/C/003698 Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.	Authorised	no	no	no	2014-07-18

International Patents for SIMBRINZA

When does loss-of-exclusivity occur for SIMBRINZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SIMBRINZA around the world.

Country	Patent Number	Title	Estimated Expiration
China	104707145	Aqueous pharmaceutical compositions containing borate-polyol complexes
Australia	2010262898	Aqueous pharmaceutical compositions containing borate-polyol complexes
European Patent Office	2442790	COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES BORATE-POLYOLS (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
China	102802604	Aqueous pharmaceutical compositions containing borate-polyol complexes

Supplementary Protection Certificates for SIMBRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	C300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221

SIMBRINZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Simbrinza

Introduction to Simbrinza

Simbrinza, a fixed-dose combination (FDC) of brinzolamide and brimonidine, is an ophthalmic suspension used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Position and Competitive Landscape

Simbrinza is positioned in a growing market for glaucoma treatments. The global glaucoma treatment market was projected to rise from $2.4 billion in 2013 to approximately $3 billion by 2023, driven by the introduction of new FDC products like Simbrinza[4].

In the competitive landscape, Simbrinza stands out due to its cost-effectiveness. Compared to other FDC products for open-angle glaucoma or ocular hypertension, Simbrinza offers significant cost savings, although it may incur additional costs when compared to certain individual drug combinations[3].

Acquisition and Commercialization

In 2021, Alcon acquired the exclusive U.S. commercialization rights to Simbrinza from Novartis. This acquisition strengthened Alcon's portfolio in the ophthalmic eye drops market, particularly in the glaucoma and dry eye segments. Alcon's existing relationships with healthcare professionals and its strong U.S. ophthalmology expertise are expected to drive the adoption of Simbrinza[1].

Financial Impact on Alcon

The acquisition of Simbrinza has had a positive financial impact on Alcon. In the Q4 2021 financial report, Alcon noted that the sales of Simbrinza, along with other recent product launches like Pataday Extra Strength, contributed to significant revenue growth. Net sales to third parties increased by 22% in 2021 compared to the previous year, with gross profit rising by 58%[5].

Revenue and Profitability

Alcon's financial performance has been bolstered by the inclusion of Simbrinza in its portfolio. The company reported an operating income of $182 million in the fourth quarter of 2021, a 29% increase from the prior year period. This growth was partly attributed to higher sales and lower amortization costs for intangible assets, including those related to Simbrinza[5].

Market Growth Drivers

The market for Simbrinza is driven by several factors:

• Increasing Prevalence of Glaucoma: The aging population in the United States and other countries is leading to an increase in glaucoma prevalence, which in turn drives the demand for effective treatments like Simbrinza[4].
• Introduction of New Products: The entry of new FDC products, including Simbrinza, into the market has contributed to sustained growth in the glaucoma treatment sector[4].
• Cost-Effectiveness: Simbrinza's cost savings compared to other treatments make it an attractive option for patients and healthcare providers, further driving its adoption[3].

Challenges and Risks

Despite the positive market dynamics, there are several challenges and risks associated with Simbrinza:

• Pricing Pressure: Changes in third-party payor coverage and reimbursement methodologies can exert pricing pressure on Simbrinza and other ophthalmic treatments[1].
• Competition: The glaucoma treatment market is highly competitive, with other FDC products and individual drug combinations vying for market share[4].
• Regulatory and Economic Factors: Global economic, financial, legal, and social changes, as well as data breaches or disruptions in supply chains, can impact the commercialization and sales of Simbrinza[1].

Safety and Efficacy

Simbrinza has a favorable safety profile, similar to that of its individual components. Clinical trials have shown that Simbrinza reduces IOP by 7-10 mmHg, representing a reduction of up to 37% from baseline. The safety profile is crucial for a chronic disease like glaucoma, which requires long-term treatment[3].

Conclusion

Simbrinza is a significant player in the glaucoma treatment market, offering a cost-effective and efficacious solution for reducing elevated IOP. The acquisition by Alcon has strengthened the company's position in the ophthalmic eye drops market and contributed to its financial growth. However, the market is subject to various challenges, including pricing pressure and competitive dynamics.

Key Takeaways

• Market Growth: The glaucoma treatment market is expected to grow, driven by the increasing prevalence of glaucoma and the introduction of new FDC products.
• Cost-Effectiveness: Simbrinza offers significant cost savings compared to other treatments, making it an attractive option.
• Financial Impact: The acquisition of Simbrinza has positively impacted Alcon's financial performance.
• Safety and Efficacy: Simbrinza has a favorable safety profile and is effective in reducing IOP.
• Challenges: The market faces challenges such as pricing pressure, competition, and regulatory risks.

FAQs

Q: What is Simbrinza used for?

A: Simbrinza is used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Q: Who acquired the U.S. commercialization rights to Simbrinza?

A: Alcon acquired the exclusive U.S. commercialization rights to Simbrinza from Novartis in 2021.

Q: How does Simbrinza compare to other glaucoma treatments in terms of cost?

A: Simbrinza is generally less expensive than other FDC products for open-angle glaucoma or ocular hypertension, although it may be more costly than certain individual drug combinations[3].

Q: What are the key drivers of the glaucoma treatment market?

A: The market is driven by the increasing prevalence of glaucoma, the introduction of new FDC products, and the cost-effectiveness of treatments like Simbrinza.

Q: What are some of the challenges facing Simbrinza in the market?

A: Challenges include pricing pressure, competition from other treatments, and various regulatory and economic risks[1].

Sources

1. Alcon to Acquire U.S. Commercialization Rights to Ophthalmic Eye Drop Simbrinza - Alcon Media Release
2. VALEO PHARMA REPORTS RECORD SECOND QUARTER 2024 REVENUES - Valeo Pharma
3. CDR Fixed-Dose Combination Review Report for Simbrinza - Common Drug Review
4. Glaucoma Treatment Market Value Projected to Hit $3 Billion by 2023 - Glaucoma Today
5. Q4 2021 Interim Financial Report - Alcon