ABACAVIR SULFATE; LAMIVUDINE - Generic Drug Details
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What are the generic sources for abacavir sulfate; lamivudine and what is the scope of patent protection?
Abacavir sulfate; lamivudine
is the generic ingredient in four branded drugs marketed by Norvium Bioscience, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Teva Pharms Usa, Zydus Pharms, Viiv Hlthcare, and Lupin Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.Six suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for ABACAVIR SULFATE; LAMIVUDINE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 10 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 6 |
| Clinical Trials: | 8 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABACAVIR SULFATE; LAMIVUDINE |
| DailyMed Link: | ABACAVIR SULFATE; LAMIVUDINE at DailyMed |
Recent Clinical Trials for ABACAVIR SULFATE; LAMIVUDINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ViiV Healthcare | Phase 4 |
| Gilead Sciences | Phase 3 |
| GlaxoSmithKline | Phase 4 |
Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE
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 ABACAVIR SULFATE; LAMIVUDINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| EPZICOM | Tablets | abacavir sulfate; lamivudine | 600 mg/300 mg | 021652 | 1 | 2007-09-27 |
US Patents and Regulatory Information for ABACAVIR SULFATE; LAMIVUDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | TRIZIVIR | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 021205-001 | Nov 14, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 204990-001 | Mar 28, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Laurus | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 216332-001 | Jul 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 206151-001 | Mar 28, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 202912-001 | Dec 5, 2013 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 ABACAVIR SULFATE; LAMIVUDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >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.
ISSN: 2162-2639
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