VALCYTE Drug Patent Profile
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When do Valcyte patents expire, and when can generic versions of Valcyte launch?
Valcyte is a drug marketed by Cheplapharm 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. Twenty-four 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 on November 4th, 2014.
Summary for VALCYTE
| International Patents: | 36 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 41 |
| Patent Applications: | 222 |
| 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 |
|---|---|
| Viracta Therapeutics, Inc. | Phase 1/Phase 2 |
| Karolinska University Hospital | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for VALCYTE
Paragraph IV (Patent) Challenges for VALCYTE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VALCYTE | for Oral Solution | valganciclovir hydrochloride | 50 mg/mL | 022257 | 1 | 2011-03-21 |
| VALCYTE | Tablets | valganciclovir hydrochloride | 450 mg | 021304 | 1 | 2005-12-27 |
US Patents and Regulatory Information for VALCYTE
VALCYTE is protected by two US patents.
Patents protecting VALCYTE
Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | 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 |
Expired US Patents for VALCYTE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VALCYTE
See the table below for patents covering VALCYTE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1122804 | ⤷ Try a Trial | |
| Netherlands | 300071 | ⤷ Try a Trial | |
| Norway | 2003001 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VALCYTE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0694547 | 2002/028 | Ireland | ⤷ Try a 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 | ⤷ Try a Trial | |
| 0694547 | 0290023-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME:VALGANCIKLOVIR |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
ISSN: 2162-2639
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