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Last Updated: March 28, 2024

Nedocromil sodium - Generic Drug Details


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What are the generic drug sources for nedocromil sodium and what is the scope of patent protection?

Nedocromil sodium is the generic ingredient in three branded drugs marketed by King Pharms Llc, Allergan, Epic Pharma Llc, and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nedocromil sodium. One supplier is listed for this compound.

Summary for nedocromil sodium
Recent Clinical Trials for nedocromil sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Indiana UniversityPhase 4
Childhood Asthma Research and Education NetworkPhase 3
Imperial College LondonPhase 2

See all nedocromil sodium clinical trials

Pharmacology for nedocromil sodium
Drug ClassMast Cell Stabilizer
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for nedocromil sodium

US Patents and Regulatory Information for nedocromil sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc NEDOCROMIL SODIUM nedocromil sodium SOLUTION/DROPS;OPHTHALMIC 090638-001 Aug 22, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan ALOCRIL nedocromil sodium SOLUTION/DROPS;OPHTHALMIC 021009-001 Dec 8, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us TILADE nedocromil sodium SOLUTION;INHALATION 020750-001 Oct 1, 1997 DISCN No No ⤷  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 nedocromil sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms Llc TILADE nedocromil sodium AEROSOL, METERED;INHALATION 019660-001 Dec 30, 1992 ⤷  Try a Trial ⤷  Try a Trial
King Pharms Llc TILADE nedocromil sodium AEROSOL, METERED;INHALATION 019660-001 Dec 30, 1992 ⤷  Try a Trial ⤷  Try a Trial
Allergan ALOCRIL nedocromil sodium SOLUTION/DROPS;OPHTHALMIC 021009-001 Dec 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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