DrugPatentWatch Database Preview
EXONDYS 51 Drug Profile
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 one hundred and ninety-six patent family members in twenty-four countries.
The generic ingredient in EXONDYS 51 is eteplirsen. One supplier is listed for this compound. Additional details are available on the eteplirsen profile page.
Summary for EXONDYS 51
| International Patents: | 196 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 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;IV (INFUSION) |
*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 |
Pharmacology for EXONDYS 51
| Drug Class | Antisense Oligonucleotide |
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 | 206488-001 | 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 |
|---|---|---|
| European Patent Office | 2349287 | Start Trial |
| Denmark | 2735568 | Start Trial |
| European Patent Office | 2351839 | Start Trial |
| Canada | 2644262 | Start Trial |
| Canada | 2651881 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
