ETEPLIRSEN - Generic Drug Details
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What are the generic sources for eteplirsen and what is the scope of patent protection?
Eteplirsen
is the generic ingredient in one branded drug marketed by Sarepta Theraps Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Eteplirsen has one hundred and twenty-seven patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for ETEPLIRSEN
| International Patents: | 127 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 11 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ETEPLIRSEN |
| What excipients (inactive ingredients) are in ETEPLIRSEN? | ETEPLIRSEN excipients list |
| DailyMed Link: | ETEPLIRSEN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ETEPLIRSEN
*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 ETEPLIRSEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kevin Flanigan | Phase 2 |
| Catabasis Pharmaceuticals | Phase 1/Phase 2 |
| Sarepta Therapeutics, Inc. | Phase 3 |
Pharmacology for ETEPLIRSEN
| Drug Class | Antisense Oligonucleotide |
Anatomical Therapeutic Chemical (ATC) Classes for ETEPLIRSEN
US Patents and Regulatory Information for ETEPLIRSEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
Expired US Patents for ETEPLIRSEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ETEPLIRSEN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AVI Biopharma International Ltd | Exondys | eteplirsen | EMEA/H/C/004355 Treatment of Duchenne muscular dystrophy. |
Refused | no | no | yes | 2018-12-06 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ETEPLIRSEN
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2021113229 | 筋障害を相殺するための手段と方法 (MEANS AND METHODS FOR COUNTERACTING MUSCLE DISORDERS) | ⤷ Sign Up |
| Japan | 2012506698 | ⤷ Sign Up | |
| Denmark | 2206781 | ⤷ Sign Up | |
| Hong Kong | 1216545 | 用於誘導外顯子跳躍的反義寡核苷酸及其使用方法 (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) | ⤷ Sign Up |
| Hong Kong | 1185098 | 高效跳過裘馨氏肌肉營養不良症前體 外顯子 的方法和工具 (METHODS AND MEANS FOR EFFICIENT SKIPPING OF EXON 45 IN DUCHENNE MUSCULAR DYSTROPHY PRE-MRNA MRNA 45) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014144978 | ⤷ Sign Up | |
| Israel | 212508 | אמצעים להשראת קפיצה באקסון 45 בפרה mrna של דיסטרופין על ידי אנטיסנס אוליקונקלאוטיד ושימושיהם (Means for efficient skipping of exon 45 in dystrophin pre-mrna using an antisense oligonucleotide and uses thereof) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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