Lamivudine; tenofovir disoproxil fumarate - Generic Drug Details
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What are the generic drug sources for lamivudine; tenofovir disoproxil fumarate and what is the scope of patent protection?
Lamivudine; tenofovir disoproxil fumarate
is the generic ingredient in three branded drugs marketed by Mylan Labs Ltd, Aurobindo Pharma Ltd, and Chartwell Rx, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound. There are seven tentative approvals for this compound.
Summary for lamivudine; tenofovir disoproxil fumarate
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 81 |
| DailyMed Link: | lamivudine; tenofovir disoproxil fumarate at DailyMed |
Recent Clinical Trials for lamivudine; tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | N/A |
| Prism Health North Texas | Phase 3 |
| Merck Sharp & Dohme LLC | Phase 3 |
See all lamivudine; tenofovir disoproxil fumarate clinical trials
Generic filers with tentative approvals for LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 300MG; 300MG | TABLET; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 300MG; 300MG; 200MG | TABLET; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 300MG; 300MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chartwell Rx | TEMIXYS | lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 211284-001 | Nov 16, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 022344-001 | May 15, 2018 | DISCN | Yes | No | ⤷ 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 |
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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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