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Generated: September 24, 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:10
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:► SubscribePatent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Aug 27, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
Patent:► SubscribePatent 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, 2002► Subscribe► Subscribe
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 2002► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Covington
Accenture
Federal Trade Commission
Julphar
Fuji
Farmers Insurance
Deloitte
US Army
QuintilesIMS
Teva

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