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Details for New Drug Application (NDA): 022184

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NDA 022184 describes LUMIGAN, which is a drug marketed by Allergan and is included in two NDAs. It is available from two suppliers. There are twelve patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LUMIGAN profile page.

The generic ingredient in LUMIGAN is bimatoprost. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the bimatoprost profile page.

Summary for NDA: 022184

Tradename:
LUMIGAN
Applicant:
Allergan
Ingredient:
bimatoprost
Patents:12
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 022184

Ingredient-typeProstaglandins

Suppliers and Packaging for NDA: 022184

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC 022184 NDA Allergan, Inc. 0023-3205 0023-3205-02 1 BOTTLE, DROPPER in 1 CARTON (0023-3205-02) > 2.5 mL in 1 BOTTLE, DROPPER
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC 022184 NDA Allergan, Inc. 0023-3205 0023-3205-03 1 BOTTLE, DROPPER in 1 CARTON (0023-3205-03) > 2.5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.01%
Approval Date:Aug 31, 2010TE:RLD:Yes
Patent:7,851,504Patent Expiration:Jun 13, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,278,353Patent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:8,933,120Patent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022184

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 20105,688,819► subscribe
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 20108,017,655► subscribe
Allergan
LUMIGAN
bimatoprost
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 20106,403,649► subscribe
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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 verifification 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.

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