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Cystadrops is a drug marketed by Recordati Rare and is included in one NDA.
The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.
Summary for CYSTADROPS
|Finished Product Suppliers / Packagers:||1|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for CYSTADROPS|
|What excipients (inactive ingredients) are in CYSTADROPS?||CYSTADROPS excipients list|
|DailyMed Link:||CYSTADROPS at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for CYSTADROPS
*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.
Recent Clinical Trials for CYSTADROPS
Identify potential brand extensions & 505(b)(2) entrants
|Recordati Rare Diseases||Phase 3|
CYSTADROPS is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CYSTADROPS is See Plans and Pricing.
This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting CYSTADROPS
Exclusivity Expiration: See Plans and Pricing
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Recordati Rare||CYSTADROPS||cysteamine hydrochloride||SOLUTION/DROPS;OPHTHALMIC||211302-001||Aug 19, 2020||RX||Yes||Yes||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|