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VALCYTE Drug Profile
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-five patent family members in thirty countries.
The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for VALCYTE
| International Patents: | 35 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 38 |
| Patent Applications: | 142 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VALCYTE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VALCYTE |
| DailyMed Link: | VALCYTE at DailyMed |
Pharmacology for VALCYTE
| Ingredient-type | Nucleoside Analog |
| Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
| Mechanism of Action | DNA Polymerase Inhibitors |
Synonyms for VALCYTE
| (S)-Valganciclovir Hydrochloride |
| [2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxy-propyl] (2S)-2-amino-3-methyl-butanoate hydrochloride |
| [2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate hydrochloride |
| 175865-59-5 |
| 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl Ester L-Valine Hydrochloride |
| 2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl (2S)-2-amino-3-methylbutanoate hydrochloride hydrate |
| 865V595 |
| AC-7501 |
| AC1L3802 |
| ACT02670 |
| AK-59963 |
| AKOS015963325 |
| AKOS030241609 |
| AN-8918 |
| BC215809 |
| BS-1015 |
| C14H22N6O5.HCl |
| C14H23ClN6O5 |
| CAS-175865-59-5 |
| CCG-213225 |
| CHEMBL1200454 |
| CS-1755 |
| CTK8F1149 |
| D03256 |
| DSSTox_CID_26784 |
| DSSTox_GSID_46784 |
| DSSTox_RID_81902 |
| DTXSID9046784 |
| EBD4420 |
| FT-0631198 |
| HY-A0032A |
| J-011142 |
| KB-278124 |
| KS-00000XN5 |
| L-Valine, 2-((2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)-3-hydroxypropyl ester, monohydrochloride |
| L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, hydrochloride (1:1) |
| L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride hydrate |
| L-Valine, ester with 9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)guanine, monohydrochloride |
| L-Valine,2[(amino-1,6-dihydro-6-oxo-9H-purin-9-y1)methoxy]-3-hydroxypropyl ester, monohydrochloride |
| LS-173676 |
| MFCD08460118 |
| MLS003876616 |
| MolPort-005-938-316 |
| MolPort-028-751-165 |
| NCGC00168779-01 |
| NSC-760349 |
| NSC760349 |
| Pharmakon1600-01503870 |
| R-127 |
| RG-127 |
| RO 107-9070/194 |
| Ro-10-79070/194 |
| Ro-1079070/194 |
| Ro107-9070/194 |
| RS 079070-194 |
| RS-079070-194 |
| RS-79070 |
| RS-79070-194 |
| SC-15265 |
| SCHEMBL23225 |
| SMR002533167 |
| TA-9070 |
| Tox21_112640 |
| Valcyt |
| Valcyte (TN) |
| Valganciclovir (hydrochloride) |
| Valganciclovir HCl |
| Valganciclovir hydrochloride |
| Valganciclovir hydrochloride (JAN/USAN) |
| Valganciclovir hydrochloride [USAN:USP] |
| Valixa |
| ZORWARFPXPVJLW-MTFPJWTKSA-N |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| 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 | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | ➤ Sign Up | ➤ Sign Up |
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for VALCYTE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | For Oral Solution | 50 mg/mL | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 450 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for VALCYTE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 20090086469 | ➤ Sign Up |
| Russian Federation | 2440118 | ➤ Sign Up |
| Australia | 2007332640 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for VALCYTE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00071 | Netherlands | ➤ Sign Up | PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920 |
| C0003 | France | ➤ Sign Up | 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 |
| C/GB02/027 | United Kingdom | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
