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TEMOZOLOMIDE Drug Profile
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Which patents cover Temozolomide, and what generic alternatives are available?
Temozolomide is a drug marketed by Accord Hlthcare, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Barr, Chartwell, Chemi Spa, Deva Holding As, Lannett Co Inc, Mylan, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms. and is included in fourteen NDAs.
The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
US ANDA Litigation and Generic Entry Outlook for Temozolomide
A generic version of TEMOZOLOMIDE was approved as temozolomide by BARR on March 1st, 2010.
Summary for TEMOZOLOMIDE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 14 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 119 |
| Clinical Trials: | 860 |
| Patent Applications: | 2,284 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TEMOZOLOMIDE |
| DailyMed Link: | TEMOZOLOMIDE at DailyMed |
Recent Clinical Trials for TEMOZOLOMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hangzhou Normal University | Phase 2 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 2 |
| ClinSearch | Phase 1 |
Pharmacology for TEMOZOLOMIDE
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for TEMOZOLOMIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TEMODAR | CAPSULE;ORAL | temozolomide | 021029 | 2008-03-24 |
| TEMODAR | CAPSULE;ORAL | temozolomide | 021029 | 2007-03-20 |
US Patents and Regulatory Information for TEMOZOLOMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 201742-006 | Feb 12, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Chemi Spa | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 204639-005 | Nov 23, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Chartwell | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 206413-002 | Apr 12, 2016 | 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 |
