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EXONDYS 51 Drug Profile
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Which patents cover Exondys 51, and what generic alternatives are available?
Exondys 51 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are seven patents protecting this drug.
This drug has two hundred and five patent family members in twenty-four countries.
The generic ingredient in EXONDYS 51 is eteplirsen. Additional details are available on the eteplirsen profile page.
US ANDA Litigation and Generic Entry Outlook for Exondys 51
Exondys 51 will be eligible for patent challenges on September 19th, 2020. 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 October 27th, 2028. This may change due to patent challenges or generic licensing.
Summary for EXONDYS 51
| International Patents: | 205 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXONDYS 51 |
| DailyMed Link: | EXONDYS 51 at DailyMed |
Generic Entry Opportunity Date for EXONDYS 51
Generic Entry Date for EXONDYS 51*:
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.
Recent Clinical Trials for EXONDYS 51
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sarepta Therapeutics | Phase 3 |
Recent Litigation for EXONDYS 51
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| University of Western Australia v. Academisch Ziekenhuis Leiden | 2016-02-25 |
US Patents and Regulatory Information for EXONDYS 51
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for EXONDYS 51
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2006213686 | Start Trial |
| Canada | 2596506 | Start Trial |
| China | 105641700 | Start Trial |
| European Patent Office | 2607484 | Start Trial |
| European Patent Office | 1668028 | Start Trial |
| European Patent Office | 3228711 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
