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Lamivudine - Generic Drug Details
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What are the generic drug sources for lamivudine and what is the scope of patent protection?
Lamivudine
is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma Ltd, Lannett Co Inc, Annora, Apotex, Arise, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Pharma Life, Strides Pharma, Micro Labs, Merck Sharp Dohme, Celltrion, Anda Repository, Hetero Labs Ltd Iii, Pharmacare, and Teva Pharms, and is included in forty-one NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twenty-nine drug master file entries for lamivudine. Nineteen suppliers are listed for this compound. There are forty-five tentative approvals for this compound.
Summary for lamivudine
| US Patents: | 5 |
| Tradenames: | 10 |
| Applicants: | 22 |
| NDAs: | 41 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 19 |
| Bulk Api Vendors: | 126 |
| Clinical Trials: | 578 |
| Patent Applications: | 7,183 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for lamivudine |
| What excipients (inactive ingredients) are in lamivudine? | lamivudine excipients list |
| DailyMed Link: | lamivudine at DailyMed |
Recent Clinical Trials for lamivudine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundação Bahiana de Infectologia | Phase 3 |
| Baylor College of Medicine | Phase 2/Phase 3 |
| Great Ormond Street Hospital for Children NHS Foundation Trust | Phase 2/Phase 3 |
Generic filers with tentative approvals for LAMIVUDINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 150MG; 300MG; 200MG | TABLET; ORAL |
| Start Trial | Start Trial | 150MG; 300MG; 600MG | TABLET; ORAL |
| Start Trial | Start Trial | 150MG; 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arise | LAMIVUDINE | lamivudine | TABLET;ORAL | 206974-001 | Nov 21, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Aurobindo Pharma Ltd | LAMIVUDINE | lamivudine | TABLET;ORAL | 202032-001 | Nov 17, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin Ltd | LAMIVUDINE | lamivudine | TABLET;ORAL | 205217-002 | Dec 18, 2014 | AB | RX | 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 |
Expired US Patents for lamivudine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | Start Trial | Start Trial |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | Start Trial | Start Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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