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The generic ingredient in CYSTARAN is cysteamine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.
Generic Entry Opportunity Date for 200740
Generic Entry Date for 200740*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CORNEAL CYSTINE CRYSTAL ACCUMULATION IN PATIENTS WITH CYSTINOSIS
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 200740
|Mechanism of Action||Cystine Disulfide Reduction |
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||SOLUTION/DROPS;OPHTHALMIC||Strength||EQ 0.44% BASE|
|Approval Date:||Oct 2, 2012||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Oct 2, 2019|
|Regulatory Exclusivity Use:||TREATMENT OF CORNEAL CYSTINE CRYSTAL ACCUMULATION IN PATIENTS WITH CYSTINOSIS|
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