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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 1 |
| Patent Applications: | 590 |
| 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 |
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
CYSTADROPS is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting CYSTADROPS
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Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
