Eteplirsen - Generic Drug Details
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What are the generic drug 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 |
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 | 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 | 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 | 206488-001 | 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 | 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 | 206488-002 | 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 | ⤷ 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 |
---|---|---|---|
Spain | 2627917 | ⤷ Sign Up | |
European Patent Office | 2344637 | PROCÉDÉS ET MOYENS D INDUCTION DU SAUT DE L EXON 45 DANS L ARN PRÉ-MESSAGER DU GÈNE DE LA DYSTROPHIE MUSCULAIRE DE DUCHENNE (METHODS AND MEANS FOR EFFICIENT SKIPPING OF EXON 45 IN DUCHENNE MUSCULAR DYSTROPHY PRE-MRNA) | ⤷ Sign Up |
European Patent Office | 3228711 | OLIGONUCLÉOTIDES ANTISENS PERMETTANT D'INDUIRE UN SAUT D'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) | ⤷ Sign Up |
Croatia | P20160078 | ⤷ Sign Up | |
New Zealand | 631289 | Improved compositions for treating muscular dystrophy | ⤷ Sign Up |
China | 105647921 | 有效跳跃人杜兴肌营养不良基因外显子43、46、50-53中至少个的方法和手段 (METHODS AND MEANS FOR EFFICIENT SKIPPING OF AT LEAST ONE EXONS 43, 46, 50-53 IN HUMAN DUCHENNE MUSCULAR DYSTROPHY GENE) | ⤷ Sign Up |
Australia | 2019203505 | Improved compositions for treating muscular dystrophy | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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