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Abacavir sulfate - Generic Drug Details
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What are the generic drug sources for abacavir sulfate and what is the scope of freedom to operate?
Abacavir sulfate
is the generic ingredient in seven branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Viiv Hlthcare, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in twenty NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for abacavir sulfate. Thirteen suppliers are listed for this compound. There are eleven tentative approvals for this compound.
Summary for abacavir sulfate
| US Patents: | 2 |
| Tradenames: | 7 |
| Applicants: | 10 |
| NDAs: | 20 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 13 |
| Bulk Api Vendors: | 125 |
| Clinical Trials: | 11 |
| Patent Applications: | 6,076 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in abacavir sulfate? | abacavir sulfate excipients list |
| DailyMed Link: | abacavir sulfate at DailyMed |
Recent Clinical Trials for abacavir sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cynthia L Gay, MD | N/A |
| National Cancer Institute (NCI) | N/A |
| ViiV Healthcare | N/A |
Generic filers with tentative approvals for ABACAVIR SULFATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 60MG | TABLET; ORAL |
| Start Trial | Start Trial | 60MG; 30MG | TABLET; ORAL |
| Start Trial | Start Trial | 60MG | 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 abacavir sulfate
| Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Paragraph IV (Patent) Challenges for ABACAVIR SULFATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZIAGEN | SOLUTION;ORAL | abacavir sulfate | 020978 | 2012-12-27 |
| ZIAGEN | TABLET;ORAL | abacavir sulfate | 020977 | 2009-01-28 |
US Patents and Regulatory Information for abacavir sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | ZIAGEN | abacavir sulfate | TABLET;ORAL | 020977-001 | Dec 17, 1998 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Aurobindo Pharma Ltd | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 206151-001 | Mar 28, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Aurobindo Pharma Ltd | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 090159-001 | Nov 15, 2018 | 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 abacavir sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | ZIAGEN | abacavir sulfate | TABLET;ORAL | 020977-001 | Dec 17, 1998 | Start Trial | Start Trial |
| Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 1998 | Start Trial | Start Trial |
| Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 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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