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CYSTADROPS Drug 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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 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
Generic Entry Date for CYSTADROPS*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT NDA:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*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
| Sponsor | Phase |
|---|---|
| Recordati Rare Diseases | Phase 3 |
Pharmacology for CYSTADROPS
| Drug Class | Cystine Depleting Agent |
| Mechanism of Action | Cystine Disulfide Reduction |
US Patents and Regulatory Information for CYSTADROPS
| 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 | Get Started Free | Get Started Free | Get Started Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
