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Last Updated: November 27, 2022

Eteplirsen - Generic Drug Details


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What are the generic drug sources for eteplirsen and what is the scope of freedom to operate?

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-three patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for eteplirsen
International Patents:123
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

SponsorPhase
Kevin FlaniganPhase 2
Catabasis PharmaceuticalsPhase 1/Phase 2
Sarepta TherapeuticsPhase 3

See all eteplirsen clinical trials

Pharmacology 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
>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 5786109 See Plans and Pricing
Israel 275424 תכשירים ושיטות לטיפול במחלות שרירים (Means and methods for counteracting muscle disorders) See Plans and Pricing
Denmark 2344637 See Plans and Pricing
Spain 2692886 See Plans and Pricing
China 105307723 Improved compositions for treating muscular dystrophy See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Baxter

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