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COMBIGAN Drug Profile
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When do Combigan patents expire, and when can generic versions of Combigan launch?
Combigan is a drug marketed by Allergan and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-five patent family members in nineteen countries.
The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. 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; timolol maleate profile page.
US ANDA Litigation and Generic Entry Outlook for Combigan
Combigan was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 19th, 2022. This may change due to patent challenges or generic licensing.
Annual sales in 2017 were $215mm indicating the motivation for generic entry (peak sales were $398mm in 2016).
There have been five patent litigation cases 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.
There are three tentative approvals for the generic drug (brimonidine tartrate; timolol maleate), which indicates the potential for near-term generic launch.
Summary for COMBIGAN
| International Patents: | 25 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COMBIGAN |
| Drug Sales Revenues: | Drug sales revenues for COMBIGAN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COMBIGAN |
| DailyMed Link: | COMBIGAN at DailyMed |
Generic Entry Opportunity Date for COMBIGAN
Generic Entry Date for COMBIGAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/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 COMBIGAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EMS | Phase 3 |
| McMaster University | N/A |
| Carmel Medical Center | Phase 2 |
Recent Litigation for COMBIGAN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALLERGAN SALES, LLC v. SANDOZ, INC. | 2017-10-30 |
| Allergan Sales, LLC v. Sandoz, Inc. | 2017-01-19 |
| Allergan, Inc. v. Sandoz, Inc. | 2012-04-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Ferrum Ferro Capital, LLC | 2015-03-09 |
Pharmacology for COMBIGAN
| Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Synonyms for COMBIGAN
| 2-Propanol, 1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-, (2S)-, mixt. with 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine |
| 952743-07-6 |
| Brimonidine / timolol |
| Brimonidine mixture with timolol |
| Brimonidine tartrate / timolol maleate |
| Brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination |
| Brimonidine tartrate and timolol maleate |
| Brimonidine Tartrate, Timolol Maleate Drug Combination |
| SCHEMBL5873369 |
Paragraph IV (Patent) Challenges for COMBIGAN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COMBIGAN | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate; timolol maleate | 021398 | 2008-11-21 |
US Patents and Regulatory Information for COMBIGAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for COMBIGAN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1496912 | Start Trial |
| Portugal | 1496912 | Start Trial |
| Mexico | PA03008401 | Start Trial |
| Taiwan | I351959 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for COMBIGAN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 2014/041 | Ireland | Start Trial | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1631293 | 92462 | Luxembourg | Start Trial | PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225 |
| 1631293 | 2014C/042 | Belgium | Start Trial | PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221 |
| 1631293 | 14C0056 | France | Start 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 |
