Alphagan P Drug Patent Profile
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Which patents cover Alphagan P, and when can generic versions of Alphagan P launch?
Alphagan P is a drug marketed by Abbvie and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has thirty-eight patent family members in nineteen countries.
The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alphagan P
A generic version of Alphagan P was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28th, 2003.
Summary for Alphagan P
International Patents: | 38 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 30 |
Clinical Trials: | 25 |
Patent Applications: | 1,354 |
Drug Prices: | Drug price information for Alphagan P |
Drug Sales Revenues: | Drug sales revenues for Alphagan P |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Alphagan P |
What excipients (inactive ingredients) are in Alphagan P? | Alphagan P excipients list |
DailyMed Link: | Alphagan P at DailyMed |
Recent Clinical Trials for Alphagan P
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Louisville | Phase 4 |
Wake Forest University Health Sciences | Phase 4 |
Uptown Eye Specialists | N/A |
Pharmacology for Alphagan P
Drug Class | alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for Alphagan P
Paragraph IV (Patent) Challenges for ALPHAGAN P
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ALPHAGAN P | Ophthalmic Solution | brimonidine tartrate | 0.1% | 021770 | 1 | 2006-12-20 |
ALPHAGAN P | Ophthalmic Solution | brimonidine tartrate | 0.15% | 021262 | 1 | 2006-11-03 |
US Patents and Regulatory Information for Alphagan P
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021770-001 | Aug 19, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 Alphagan P
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021770-001 | Aug 19, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Alphagan P
See the table below for patents covering Alphagan P around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2474280 | COMPOSITIONS CONTENANT DES COMPOSANTS AGONISTES ALPHA-2 ADRENERGIQUES (COMPOSITIONS CONTAINING ALPHA-2-ADRENERGIC AGONIST COMPONENTS) | ⤷ Try a Trial |
Japan | 4927298 | ⤷ Try a Trial | |
China | 101897704 | ⤷ Try a Trial | |
Mexico | PA02012206 | COMPOSICIONES QUE CONTIENEN COMPONENTES TERAPEUTICAMENTE ACTIVOS QUE TIENEN SOLUBILIDAD MEJORADA. (COMPOSITIONS CONTAINING THERAPEUTICALLY ACTIVE COMPONENTS HAVING ENHANCED SOLUBILITY.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Alphagan P
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1631293 | C300683 | 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 | 2014C/042 | Belgium | ⤷ Try a 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 | 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 | 92462 | Luxembourg | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |