VALCYTE Drug Patent Profile
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Which patents cover Valcyte, and what generic alternatives are available?
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 |
|---|---|---|---|
| New Zealand | 577179 | POWDER FORMULATION FOR VALGANCICLOVIR | ⤷ Try a Trial |
| Hungary | 9502238 | ⤷ Try a Trial | |
| Taiwan | 200840585 | Powder formulation for valganciclovir | ⤷ 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 | 03C0003 | France | ⤷ Try a 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 | 0290023-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME:VALGANCIKLOVIR |
| 0694547 | 91136 | Luxembourg | ⤷ Try a Trial | 91136, EXPIRES: 20160920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
ISSN: 2162-2639
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