GANZYK-RTU Drug Patent Profile
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When do Ganzyk-rtu patents expire, and when can generic versions of Ganzyk-rtu launch?
Ganzyk-rtu is a drug marketed by Exela Pharma and is included in one NDA. There is one patent protecting this drug.
The generic ingredient in GANZYK-RTU is ganciclovir. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.
DrugPatentWatch® Generic Entry Outlook for Ganzyk-rtu
Indicators of Generic Entry
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Questions you can ask:
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Summary for GANZYK-RTU
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | GANZYK-RTU at DailyMed |
Pharmacology for GANZYK-RTU
| Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
| Mechanism of Action | DNA Polymerase Inhibitors |
US Patents and Regulatory Information for GANZYK-RTU
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | GANZYK-RTU | ganciclovir | SOLUTION;INTRAVENOUS | 209347-001 | Feb 17, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for GANZYK-RTU
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH.. | Vitrasert Implant | ganciclovir | EMEA/H/C/000120 The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use). |
Withdrawn | no | no | no | 1997-03-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
