CYSTADANE Drug Patent Profile
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Which patents cover Cystadane, and what generic alternatives are available?
Cystadane is a drug marketed by Recordati Rare and is included in one NDA.
The generic ingredient in CYSTADANE is betaine. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the betaine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cystadane
A generic version of CYSTADANE was approved as betaine by NOVITIUM PHARMA on November 23rd, 2021.
Summary for CYSTADANE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 21 |
| Clinical Trials: | 3 |
| Patent Applications: | 199 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CYSTADANE |
| What excipients (inactive ingredients) are in CYSTADANE? | CYSTADANE excipients list |
| DailyMed Link: | CYSTADANE at DailyMed |
Recent Clinical Trials for CYSTADANE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 2 |
| McGill University Health Center | Phase 2 |
| March of Dimes | Phase 2 |
Pharmacology for CYSTADANE
| Drug Class | Methylating Agent |
| Mechanism of Action | Methylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for CYSTADANE
US Patents and Regulatory Information for CYSTADANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | CYSTADANE | betaine | FOR SOLUTION;ORAL | 020576-001 | Oct 25, 1996 | AB | 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 |
