TROKENDI XR Drug Patent Profile
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When do Trokendi Xr patents expire, and what generic alternatives are available?
Trokendi Xr is a drug marketed by Supernus Pharms and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.
This drug has eleven patent family members in eight countries.
The generic ingredient in TROKENDI XR is topiramate. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the topiramate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Trokendi Xr
A generic version of TROKENDI XR was approved as topiramate by ACCORD HLTHCARE on March 27th, 2009.
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Summary for TROKENDI XR
| International Patents: | 11 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 1 |
| Patent Applications: | 5,077 |
| Drug Prices: | Drug price information for TROKENDI XR |
| Drug Sales Revenues: | Drug sales revenues for TROKENDI XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TROKENDI XR |
| What excipients (inactive ingredients) are in TROKENDI XR? | TROKENDI XR excipients list |
| DailyMed Link: | TROKENDI XR at DailyMed |
See drug prices for TROKENDI XR
Recent Clinical Trials for TROKENDI XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Minnesota | Phase 2 |
| Supernus Pharmaceuticals, Inc. | Phase 2 |
| University of Minnesota - Clinical and Translational Science Institute | Phase 2 |
Pharmacology for TROKENDI XR
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for TROKENDI XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TROKENDI XR | Extended-release Capsules | topiramate | 25 mg, 50 mg, and 100 mg | 201635 | 1 | 2014-05-12 |
| TROKENDI XR | Extended-release Capsules | topiramate | 200 mg | 201635 | 1 | 2014-04-03 |
US Patents and Regulatory Information for TROKENDI XR
TROKENDI XR is protected by twenty US patents.
Patents protecting TROKENDI XR
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Sustained-release formulations of topiramate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Supernus Pharms | TROKENDI XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635-004 | Aug 16, 2013 | AB1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Supernus Pharms | TROKENDI XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635-003 | Aug 16, 2013 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Supernus Pharms | TROKENDI XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635-003 | Aug 16, 2013 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 TROKENDI XR
See the table below for patents covering TROKENDI XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2312308 | ⤷ Sign Up | |
| European Patent Office | 1973528 | FORMULATIONS DE TOPIRAMATE À LIBÉRATION PROLONGÉE (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE) | ⤷ Sign Up |
| European Patent Office | 2394643 | Formulations à libération prolongée de topiramate (Sustained-release formulations of topiramate) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TROKENDI XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2317997 | 2190050-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212 |
| 0138441 | SPC/GB95/028 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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