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Generated: June 23, 2017
What is the patent landscape for Valcyte, and what generic Valcyte alternatives are available?
Valcyte is a drug marketed by Hoffmann La Roche and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 34 |
| Clinical Trials: see list | 35 |
| Patent Applications: see list | 120 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | VALCYTE at DailyMed |
| Ingredient-type | Nucleoside Analog |
| Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
| Mechanism of Action | DNA Polymerase Inhibitors |
| 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 | TABLET;ORAL | 021304-001 | Mar 29, 2001 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | 9,642,911 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| 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 | 6,083,953*PED | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | 6,083,953*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| valganciclovir hydrochloride | For Oral Solution | 50 mg/mL | Valcyte | 3/21/2011 |
| valganciclovir hydrochloride | Tablets | 450 mg | Valcyte | 12/27/2005 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,889,109 | Pharmaceutical dosage forms comprising valganciclovir hydrochloride | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Peru | 15782008 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2391912 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2010513237 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | I341730 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 2101733 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 02/028 | Ireland | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C/GB02/027 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C0003 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 00071 | Netherlands | ► Subscribe | PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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