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Last Updated: June 28, 2022

CYSTADROPS Drug Patent Profile

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

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
Drug patent expirations by year for CYSTADROPS
Drug Prices for CYSTADROPS

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for CYSTADROPS
Generic Entry Date for CYSTADROPS*:
Constraining patent/regulatory exclusivity:

*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 DiseasesPhase 3

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Pharmacology for CYSTADROPS

US Patents and Regulatory Information for CYSTADROPS

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.