Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
McKesson
Colorcon
McKinsey
Dow

Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Lamivudine; tenofovir disoproxil fumarate - Generic Drug Details

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

What are the generic sources for lamivudine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Lamivudine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Mylan Labs Ltd, Aurobindo Pharma Ltd, and Celltrion, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lamivudine; tenofovir disoproxil fumarate. Two suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for lamivudine; tenofovir disoproxil fumarate
Recent Clinical Trials for lamivudine; tenofovir disoproxil fumarate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hospital Universitari de BellvitgePhase 2
Institut d'Investigació Biomèdica de BellvitgePhase 2
Fundacio Lluita Contra la SIDAPhase 2

See all lamivudine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MG; 300MGTABLET; ORAL
  Start Trial  Start Trial300MG; 300MG; 200MGTABLET; ORAL
  Start Trial  Start Trial300MG; 300MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for lamivudine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd CIMDUO lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022141-001 Feb 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celltrion TEMIXYS lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 211284-001 Nov 16, 2018 RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022344-001 May 15, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Moodys
Express Scripts
Merck
Medtronic

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.