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Atorvastatin calcium - Generic Drug Details
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What are the generic drug sources for atorvastatin calcium and what is the scope of patent protection?
Atorvastatin calcium
is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Graviti Pharms, Invagen Pharms, Lannett Co Inc, Lupin Ltd, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Thepharmanetwork Llc, Umedica Labs Pvt Ltd, Zydus Pharms, Upjohn, Scov3, and Merck Sharp Dohme, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are sixty-two drug master file entries for atorvastatin calcium. Fifty-four suppliers are listed for this compound.
Summary for atorvastatin calcium
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 22 |
| NDAs: | 23 |
| Drug Master File Entries: | 62 |
| Suppliers / Packagers: | 54 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 47 |
| Patent Applications: | 7,569 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for atorvastatin calcium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for atorvastatin calcium |
| DailyMed Link: | atorvastatin calcium at DailyMed |
Recent Clinical Trials for atorvastatin calcium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 2 |
| Mount Auburn Hospital | Phase 2 |
| Shandong University | Phase 4 |
Pharmacology for atorvastatin calcium
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for atorvastatin calcium
Paragraph IV (Patent) Challenges for ATORVASTATIN CALCIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LIPITOR | TABLET;ORAL | atorvastatin calcium | 020702 |
US Patents and Regulatory Information for atorvastatin calcium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz Inc | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 077575-003 | May 29, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Msn | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 211933-003 | Feb 8, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Pharms Inc | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 091226-001 | May 29, 2012 | 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 atorvastatin calcium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | Start Trial | Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | Start Trial | Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | 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.
ISSN: 2162-2639
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