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Last Updated: October 27, 2021

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Details for New Drug Application (NDA): 021262

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NDA 021262 describes ALPHAGAN P, which is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ALPHAGAN P profile page.

The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for 021262

Tradename:	ALPHAGAN P
Applicant:	Allergan
Ingredient:	brimonidine tartrate
Patents:	5

Pharmacology for NDA: 021262

Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for 021262

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 021262

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262	NDA	Allergan, Inc.	0023-9177	0023-9177-05	1 BOTTLE, DROPPER in 1 CARTON (0023-9177-05) > 5 mL in 1 BOTTLE, DROPPER
ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262	NDA	Allergan, Inc.	0023-9177	0023-9177-10	1 BOTTLE, DROPPER in 1 CARTON (0023-9177-10) > 10 mL in 1 BOTTLE, DROPPER

Paragraph IV (Patent) Challenges for 021262

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALPHAGAN P	SOLUTION/DROPS;OPHTHALMIC	brimonidine tartrate	021262	2006-11-03

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.15%
Approval Date:	Mar 16, 2001	TE:	AT	RLD:	Yes
Patent:	⤷ Try it Free	Patent Expiration:	Jan 10, 2022	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Try it Free	Patent Expiration:	Jan 18, 2022	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Try it Free	Patent Expiration:	Jan 28, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021262

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	⤷ Try it Free	⤷ Try it Free
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	⤷ Try it Free	⤷ Try it Free
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.