➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Mallinckrodt
McKesson
Dow
Moodys

Last Updated: June 25, 2021

DrugPatentWatch Database Preview

AMONDYS 45 Drug Profile


Email this page to a colleague

« Back to Dashboard

When do Amondys 45 patents expire, and what generic alternatives are available?

Amondys 45 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and sixty-six patent family members in twenty-three countries.

The generic ingredient in AMONDYS 45 is casimersen. One supplier is listed for this compound. Additional details are available on the casimersen profile page.

DrugPatentWatch® Generic Entry Outlook for Amondys 45

Amondys 45 will be eligible for patent challenges on February 25, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Get Started Free

Summary for AMONDYS 45
International Patents:166
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in AMONDYS 45?AMONDYS 45 excipients list
DailyMed Link:AMONDYS 45 at DailyMed
Drug patent expirations by year for AMONDYS 45
DrugPatentWatch® Estimated Generic Entry Opportunity Date for AMONDYS 45
Generic Entry Date for AMONDYS 45*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for AMONDYS 45

US Patents and Regulatory Information for AMONDYS 45

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 AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 AMONDYS 45

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021   Get Started Free   Get Started Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AMONDYS 45

Country Patent Number Estimated Expiration
Canada 2584599   Get Started Free
Poland 1766012   Get Started Free
World Intellectual Property Organization (WIPO) 2011057350   Get Started Free
Spain 2693459   Get Started Free
World Intellectual Property Organization (WIPO) 2006033933   Get Started Free
New Zealand 626359   Get Started Free
Hungary E040445   Get Started Free
>Country >Patent Number >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Colorcon
Dow
Medtronic
Harvard Business School

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.