TEMODAR Drug Patent Profile
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Which patents cover Temodar, and when can generic versions of Temodar launch?
Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs.
The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Temodar
A generic version of TEMODAR was approved as temozolomide by SUN PHARM on February 12th, 2014.
Summary for TEMODAR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 144 |
Clinical Trials: | 302 |
Patent Applications: | 3,689 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TEMODAR |
What excipients (inactive ingredients) are in TEMODAR? | TEMODAR excipients list |
DailyMed Link: | TEMODAR at DailyMed |
Recent Clinical Trials for TEMODAR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Xynomic Pharmaceuticals, Inc. | Phase 1 |
Orbus Therapeutics, Inc. | Phase 1 |
Kari Kendra | Phase 1/Phase 2 |
Pharmacology for TEMODAR
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for TEMODAR
Paragraph IV (Patent) Challenges for TEMODAR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TEMODAR | Capsules | temozolomide | 140 mg and 180 mg | 021029 | 1 | 2008-03-24 |
TEMODAR | Capsules | temozolomide | 5 mg, 20 mg, 100 mg and 250 mg | 021029 | 1 | 2007-03-20 |
US Patents and Regulatory Information for TEMODAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | TEMODAR | temozolomide | CAPSULE;ORAL | 021029-001 | Aug 11, 1999 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck Sharp Dohme | TEMODAR | temozolomide | POWDER;INTRAVENOUS | 022277-001 | Feb 27, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck Sharp Dohme | TEMODAR | temozolomide | CAPSULE;ORAL | 021029-005 | Oct 19, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 TEMODAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | TEMODAR | temozolomide | POWDER;INTRAVENOUS | 022277-001 | Feb 27, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | TEMODAR | temozolomide | CAPSULE;ORAL | 021029-003 | Aug 11, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | TEMODAR | temozolomide | CAPSULE;ORAL | 021029-001 | Aug 11, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TEMODAR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
medac Gesellschaft für klinische Spezialpräparate mbH | Temomedac | temozolomide | EMEA/H/C/001124 Temomedac hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
Authorised | yes | no | no | 2010-01-25 | |
Accord Healthcare S.L.U. | Temozolomide Accord | temozolomide | EMEA/H/C/001125 For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
Authorised | yes | no | no | 2010-03-15 | |
Sun Pharmaceutical Industries Europe B.V. | Temozolomide Sun | temozolomide | EMEA/H/C/002198 Temozolomide Sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
Authorised | yes | no | no | 2011-07-13 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TEMODAR
See the table below for patents covering TEMODAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 890000094 | ⤷ Try a Trial | |
Hong Kong | 1066466 | Pharmaceutical formulations of antineoplastic agents in particular temozolomide processes of making and using the same | ⤷ Try a Trial |
Australia | 571430 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |