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Last Updated: December 2, 2024

CROMOLYN SODIUM Drug Patent Profile


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Which patents cover Cromolyn Sodium, and when can generic versions of Cromolyn Sodium launch?

Cromolyn Sodium is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Apotex Inc, Sandoz, Sciegen Pharms Inc, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Bausch And Lomb, Hh And P, and Perrigo. and is included in twenty-two NDAs.

The generic ingredient in CROMOLYN SODIUM is cromolyn sodium. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cromolyn Sodium

A generic version of CROMOLYN SODIUM was approved as cromolyn sodium by SANDOZ on June 16th, 1999.

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Summary for CROMOLYN SODIUM
US Patents:0
Applicants:20
NDAs:22
Finished Product Suppliers / Packagers: 16
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 23
Patent Applications: 4,783
What excipients (inactive ingredients) are in CROMOLYN SODIUM?CROMOLYN SODIUM excipients list
DailyMed Link:CROMOLYN SODIUM at DailyMed
Drug patent expirations by year for CROMOLYN SODIUM
Recent Clinical Trials for CROMOLYN SODIUM

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

SponsorPhase
Texas Tech University Health Sciences Center, El PasoPhase 3
Adli Karadsheh, MD, MSPhase 3
MedAvantePhase 2

See all CROMOLYN SODIUM clinical trials

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

US Patents and Regulatory Information for CROMOLYN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ailex Pharms Llc CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 209264-001 Oct 16, 2017 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Wockhardt Bio Ag CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075346-001 Oct 25, 1999 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc CROMOLYN SODIUM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 074706-001 Apr 29, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 202583-001 Oct 27, 2011 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075333-001 Apr 30, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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