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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050790

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NDA 050790 describes RESTASIS MULTIDOSE, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug. Additional details are available on the RESTASIS MULTIDOSE profile page.

The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Summary for NDA: 050790

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Immunological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 050790

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC 050790 NDA Allergan, Inc. 0023-5301 0023-5301-01 1 BOTTLE in 1 CARTON (0023-5301-01) > 1.5 mL in 1 BOTTLE
RESTASIS MULTIDOSE
cyclosporine
EMULSION;OPHTHALMIC 050790 NDA Allergan, Inc. 0023-5301 0023-5301-01 1 BOTTLE in 1 CARTON (0023-5301-01) > 1.5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Dec 23, 2002TE:RLD:Yes
Patent:8,629,111Patent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,642,556Patent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,685,930Patent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 050790

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 20024,839,342► Subscribe
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 20025,474,979► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Dow
Fuji
Julphar
Cantor Fitzgerald
Queensland Health
Express Scripts
Healthtrust
Cerilliant
QuintilesIMS

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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