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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for eteplirsen
Generic Entry Date for eteplirsen*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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 | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | 10,781,451 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | RE47769 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | RE47751 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 10,533,174 | ⤷ Subscribe |
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | 10,533,174 | ⤷ Subscribe |
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | 9,416,361 | ⤷ Subscribe |
>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 | 6885620 | ⤷ Subscribe | |
European Patent Office | 3400948 | PROCÉDÉS ET MOYENS POUR SAUTER EFFICACEMENT AU MOINS L`UN DES EXONS SUIVANTS DU GÈNE DE LA DYSTROPHIE MUSCULAIRE HUMAINE DE DUCHENNE : 43, 46, 50 À 53 (METHODS AND MEANS FOR EFFICIENT SKIPPING OF AT LEAST ONE OF THE FOLLOWING EXONS OF THE HUMAN DUCHENNE MUSCULAR DYSTROPHY GENE: 43, 46, 50- 53) | ⤷ Subscribe |
Israel | 278912 | תכשירים משופרים לטיפול דיסטרופיה של השרירים (Improved compositions for treating muscular dystrophy) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Eteplirsen Market Analysis and Financial Projection Experimental
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