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Last Updated: July 2, 2022

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 patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for eteplirsen
International Patents:120
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 Therapeutics, Inc.Phase 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 Y 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 Y Y 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 Y 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 206488-002 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 206488-002 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 206488-001 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
>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 2016033140 筋障害を相殺するための手段と方法 (MEANS AND METHODS FOR COUNTERACTING MUSCLE DISORDERS) See Plans and Pricing
Spain 2639852 See Plans and Pricing
Israel 278912 See Plans and Pricing
Japan 2012506697 See Plans and Pricing
Cyprus 1117454 See Plans and Pricing
Portugal 2203173 See Plans and Pricing
New Zealand 592498 METHODS AND MEANS FOR EFFICIENT SKIPPING OF EXON 52 OF THE HUMAN DUCHENNE MUSCULAR DYSTROPHY GENE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Harvard Business School
Colorcon
Merck
Mallinckrodt

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.