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VALCYTE Drug Profile
» See Plans and Pricing
When do Valcyte patents expire, and when can generic versions of Valcyte launch?
Valcyte is a drug marketed by Hoffmann La Roche and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-six patent family members in thirty-one countries.
The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Valcyte
A generic version of VALCYTE was approved as valganciclovir hydrochloride by DR REDDYS LABS LTD on November 4th, 2014.
Summary for VALCYTE
| International Patents: | 36 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 40 |
| Patent Applications: | 180 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VALCYTE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VALCYTE |
| What excipients (inactive ingredients) are in VALCYTE? | VALCYTE excipients list |
| DailyMed Link: | VALCYTE at DailyMed |
Recent Clinical Trials for VALCYTE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Karolinska University Hospital | Phase 2 |
| Cecilia Soderberg-Naucler | Phase 2 |
| Karolinska Institutet | Phase 2 |
Pharmacology for VALCYTE
| Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
| Mechanism of Action | DNA Polymerase Inhibitors |
Paragraph IV (Patent) Challenges for VALCYTE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VALCYTE | FOR SOLUTION;ORAL | valganciclovir hydrochloride | 022257 | 2011-03-21 |
| VALCYTE | TABLET;ORAL | valganciclovir hydrochloride | 021304 | 2005-12-27 |
US Patents and Regulatory Information for VALCYTE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VALCYTE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | Start Trial | Start Trial |
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VALCYTE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 198854 | Start Trial |
| Croatia | P20121033 | Start Trial |
| Russian Federation | 95113148 | Start Trial |
| Spain | 2083348 | Start Trial |
| Germany | 69509173 | Start Trial |
| South Korea | 20090086469 | Start Trial |
| Morocco | 31280 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VALCYTE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0694547 | 03C0003 | France | Start Trial | PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920 |
| 0694547 | C300071 | Netherlands | Start Trial | PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920 |
| 0694547 | SPC/GB02/027 | United Kingdom | Start Trial | PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425 |
| 0694547 | SPC028/2002 | Ireland | Start Trial | SPC028/2002: 20040929, EXPIRES: 20160919 |
| 0694547 | 0290023-1 | Sweden | Start Trial | PRODUCT NAME:VALGANCIKLOVIR |
| 0694547 | 2002/028 | Ireland | Start Trial | PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013 |
| 0694547 | CA 2002 00021 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
