Valganciclovir Hydrochloride Patent Expiration

Valganciclovir Hydrochloride is Used for preventing CMV disease in high-risk kidney, heart, and kidney-pancreas transplant patients. It was first introduced by Cheplapharm Arzneimittel Gmbh in its drug Valcyte on Mar 29, 2001. 14 different companies have introduced drugs containing Valganciclovir Hydrochloride.


Valganciclovir Hydrochloride Patents

Given below is the list of patents protecting Valganciclovir Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Valcyte US8889109 Pharmaceutical dosage forms comprising valganciclovir hydrochloride Dec 11, 2027 Cheplapharm
Valcyte US9642911 Pharmaceutical dosage forms comprising valganciclovir hydrochloride Dec 11, 2027 Cheplapharm
Valcyte US6083953

(Pediatric)

2- (2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3- propanediol derivative Sep 29, 2015

(Expired)

Cheplapharm
Valcyte US6083953 2- (2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3- propanediol derivative Mar 29, 2015

(Expired)

Cheplapharm



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Valganciclovir Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Valganciclovir Hydrochloride.

Activity Date Patent Number
Patent litigations
Email Notification 30 Aug, 2022 US9642911
Change in Power of Attorney (May Include Associate POA) 30 Aug, 2022 US9642911
Correspondence Address Change 26 Aug, 2022 US9642911
Change in Power of Attorney (May Include Associate POA) 25 Aug, 2022 US8889109
Correspondence Address Change 24 Aug, 2022 US8889109
Payment of Maintenance Fee, 8th Year, Large Entity 12 Apr, 2022 US8889109
Payment of Maintenance Fee, 4th Year, Large Entity 28 Sep, 2020 US9642911
Surcharge for Late Payment, Large Entity 21 Aug, 2018 US8889109
Payment of Maintenance Fee, 4th Year, Large Entity 21 Aug, 2018 US8889109
Maintenance Fee Reminder Mailed 02 Jul, 2018 US8889109


Valganciclovir Hydrochloride's Family Patents

Family Patents

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Valganciclovir Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Valganciclovir Hydrochloride. The first generic version for Valganciclovir Hydrochloride was by Strides Pharma Global Pte Ltd and was approved on Nov 4, 2014. And the latest generic version is by Somerset Therapeutics Llc and was approved on Jun 11, 2024.

Given below is the list of companies who have filed for Valganciclovir Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

for solution Prescription ORAL AB Jul 18, 2016





2. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 2 different strengths of generic version for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Prescription ORAL AB Dec 26, 2019
50MG/ML

for solution Prescription ORAL AB Jan 13, 2020


Manufacturing Plant Locations
New

Ajanta Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Ajanta Pharma Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Ajanta Pharma Ltd.





3. APPCO

Appco Pharma Llc has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Appco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

for solution Prescription ORAL AB Apr 11, 2023


Manufacturing Plant Locations
New

Appco's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Appco as present at those locations.

Country City Firm Name
United States
Somerset Appco Pharma, LLC
Piscataway Appco Pharma LLC





4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

for solution Prescription ORAL AB Nov 17, 2022


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Prescription ORAL AB Mar 31, 2016


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





6. CIPLA

Cipla Ltd has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Discontinued ORAL N/A Nov 9, 2018


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Bangalore Cipla Ltd.
Vasco Da Gama Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Pithampur, District Dhar Cipla Limited
Bengaluru Cipla Limited
Raigad Cipla Limited
Mumbai Cipla Limited





7. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Prescription ORAL AB Dec 12, 2017





8. GRANULES

Granules Pharmaceuticals Inc has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

for solution Prescription ORAL AB Jan 31, 2020


Manufacturing Plant Locations
New

Granules's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Granules as present at those locations.

Country City Firm Name
United States
Manassas Granules Consumer Health Inc.
Chantilly Granules Pharmaceuticals Inc.
India
Sangareddy District Granules India Limited
Visakhapatnam Granules India Limited
Secunderabad Granules India Limited
Parawada Mandal Granules India Limited
Medchal-Malkhajgiri District Granules India Limited





9. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Prescription ORAL AB Mar 18, 2016
50MG/ML

for solution Prescription ORAL AB Oct 4, 2022





10. MSN

Msn Laboratories Private Ltd has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

for solution Prescription ORAL AB Feb 17, 2022


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Sangareddy MSN Laboratories Private Ltd.
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited
Sangareddy MSN Laboratories Private Limited, R&D Center
Kamareddy MSN Life Sciences Private Limited
Sangareddy MSN Pharmachem Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Medak MSN LIFE SCIENCES PRIVATE LIMITED
United States
Piscataway MSN PHARMACEUTICALS INC





11. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Discontinued ORAL N/A Mar 3, 2021





12. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Prescription ORAL AB Jun 11, 2024





13. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Valganciclovir Hydrochloride. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 450MG BASE

tablet Prescription ORAL AB Nov 4, 2014


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited