SIMBRINZA Drug Patent Profile
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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 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: | 50 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 9 |
Patent Applications: | 18 |
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 |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIMBRINZA
Generic Entry Date for SIMBRINZA*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Pharmacology for SIMBRINZA
Drug Class | Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Carbonic Anhydrase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SIMBRINZA
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIMBRINZA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SIMBRINZA
Aqueous pharmaceutical compositions containing borate-polyol complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Aqueous pharmaceutical compositions containing borate-polyol complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alcon Labs Inc | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 7126
Estimated Expiration: ⤷ Try a Trial
Patent: 2017
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 10262898
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 1015996
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 63778
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 10000634
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2802604
Estimated Expiration: ⤷ Try a Trial
Patent: 4707145
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0160953
Estimated Expiration: ⤷ Try a Trial
Patent: 0200979
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17835
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 42790
Estimated Expiration: ⤷ Try a Trial
Patent: 22035
Estimated Expiration: ⤷ Try a Trial
Patent: 45164
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 42790
Estimated Expiration: ⤷ Try a Trial
Patent: 22035
Estimated Expiration: ⤷ Try a Trial
Patent: 45164
Estimated Expiration: ⤷ Try a Trial
Patent: 37634
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 63521
Estimated Expiration: ⤷ Try a Trial
Patent: 94007
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 30435
Estimated Expiration: ⤷ Try a Trial
Patent: 49477
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 17956
Estimated Expiration: ⤷ Try a Trial
Patent: 12530712
Estimated Expiration: ⤷ Try a Trial
Patent: 14198729
Estimated Expiration: ⤷ Try a Trial
Patent: 16183198
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 45164
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11013107
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 42790
Estimated Expiration: ⤷ Try a Trial
Patent: 22035
Estimated Expiration: ⤷ Try a Trial
Patent: 45164
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 42790
Estimated Expiration: ⤷ Try a Trial
Patent: 22035
Estimated Expiration: ⤷ Try a Trial
Patent: 45164
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 63125
Estimated Expiration: ⤷ Try a Trial
Patent: 12101782
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01600249
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 42790
Estimated Expiration: ⤷ Try a Trial
Patent: 22035
Estimated Expiration: ⤷ Try a Trial
Patent: 45164
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1108384
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1738502
Estimated Expiration: ⤷ Try a Trial
Patent: 120028390
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 61617
Estimated Expiration: ⤷ Try a Trial
Patent: 84858
Estimated Expiration: ⤷ Try a Trial
Patent: 03648
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 89997
Estimated Expiration: ⤷ Try a Trial
Patent: 1100103
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 709
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Croatia | P20160953 | ⤷ Try a Trial | |
Australia | 2010262898 | Aqueous pharmaceutical compositions containing borate-polyol complexes | ⤷ Try a Trial |
European Patent Office | 2442790 | COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES BORATE-POLYOLS (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIMBRINZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1631293 | 300683 | Netherlands | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
1631293 | 14C0056 | France | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |