DEUTETRABENAZINE - Generic Drug Details
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What are the generic drug sources for deutetrabenazine and what is the scope of patent protection?
Deutetrabenazine
is the generic ingredient in two branded drugs marketed by Teva and Teva Branded Pharm, and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Deutetrabenazine has one hundred and thirty-six patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for DEUTETRABENAZINE
| International Patents: | 136 |
| US Patents: | 14 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 15 |
| Patent Applications: | 3,861 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEUTETRABENAZINE |
| What excipients (inactive ingredients) are in DEUTETRABENAZINE? | DEUTETRABENAZINE excipients list |
| DailyMed Link: | DEUTETRABENAZINE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEUTETRABENAZINE
Generic Entry Dates for DEUTETRABENAZINE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for DEUTETRABENAZINE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for DEUTETRABENAZINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanderbilt University Medical Center | Phase 2/Phase 3 |
| Fundacion Huntington Puerto Rico | Phase 1 |
| Teva Branded Pharmaceutical Products, R&D Inc. | Phase 1/Phase 2 |
Paragraph IV (Patent) Challenges for DEUTETRABENAZINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AUSTEDO | Tablets | deutetrabenazine | 6 mg, 9 mg and 12 mg | 208082 | 2 | 2021-04-05 |
US Patents and Regulatory Information for DEUTETRABENAZINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-001 | Apr 3, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-002 | Feb 17, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-002 | Feb 17, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-002 | Apr 3, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-001 | Apr 3, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-003 | Apr 3, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Teva | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-001 | Feb 17, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for DEUTETRABENAZINE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2652289 | ⤷ Try a Trial | |
| Australia | 2018222896 | Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 | ⤷ Try a Trial |
| South Africa | 201902108 | METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS | ⤷ Try a Trial |
| Hungary | E038158 | ⤷ Try a Trial | |
| Israel | 288712 | שיטות לטיפול בהפרעות תנועה לא נורמליות (Methods for the treatment of abnormal involuntary movement disorders) | ⤷ Try a Trial |
| India | 1662DEN2015 | ⤷ Try a Trial | |
| Japan | 2019059784 | 小胞モノアミン輸送体２の重水素化ベンゾキノリン阻害剤の製剤薬物動態 (PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VASCULAR MONOAMINE TRANSPORTER 2) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
