DrugPatentWatch Database Preview
ZULRESSO Drug Profile
When do Zulresso patents expire, and when can generic versions of Zulresso launch?
Zulresso is a drug marketed by Sage Therap and is included in one NDA. There are seven patents protecting this drug.
This drug has fifty-three patent family members in sixteen countries.
The generic ingredient in ZULRESSO is brexanolone. One supplier is listed for this compound. Additional details are available on the brexanolone profile page.
Summary for ZULRESSO
| International Patents: | 53 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 42 |
| Patent Applications: | 185 |
| Drug Prices: | Drug price information for ZULRESSO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZULRESSO |
| DailyMed Link: | ZULRESSO at DailyMed |
Generic Entry Opportunity Date for ZULRESSO
Generic Entry Date for ZULRESSO*:
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 Litigation for ZULRESSO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA | 2019-05-23 |
| MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED | 2018-03-29 |
| CyDex Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-12-20 |
Synonyms for ZULRESSO
| (+)-3a-Hydroxy-5a-pregnan-20-one |
| (1S,2S,7S,11S,14S,15S,5R,10R)-14-acetyl-5-hydroxy-2,15-dimethyltetracyclo[8.7. 0.0<2,7>.0<11,15>]heptadecane |
| (3?,5?)-3-Hydroxy-pregnan-20-one |
| (3|A)-Allopregnanolone |
| (3a)-Allopregnanolone |
| (3alpha,5alpha)-3-hydroxypregnan-20-one |
| (3alpha)-Allopregnanolone |
| 1-((3R,5S,8R,9S,10S,13S,14S,17S)-3-hydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)ethan-1-one |
| 1-((3R,5S,8R,9S,10S,13S,14S,17S)-3-Hydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)ethanone |
| 1-[(3R,5S,8R,9S,10S,13S,14S,17S)-3-hydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]ethanone |
| 3-a-tetrahydroprogesterone |
| 3-alpha-Hydroxy-5-alpha-pregnan-20-one |
| 3-alpha-tetrahydroprogesterone |
| 3-alpha,5-alpha-Pregnanolone |
| 3-alpha,5-alpha-Tetrahydroprogesterone |
| 3|A-hydroxy-5|A-pregnan-20-one |
| 3|A-OH-DHP |
| 3|A,5|A-THP |
| 3a-Hydroxy-5a-dihydroprogesterone |
| 3a-Hydroxy-5a-pregnan-20-one |
| 3a-Hydroxy-5a-pregnane-20-one |
| 3a,5a-Pregnanolone |
| 3a,5a-Tetrahydroprogesterone |
| 3a,5a-THP |
| 3a,5a-THPROG |
| 3alpha-Hydroxy-5alpha-20-one |
| 3alpha-Hydroxy-5alpha-dihydroprogesterone |
| 3alpha-hydroxy-5alpha-pregnan-20-one |
| 3alpha-hydroxy-5alpha-pregnane-20-one |
| 3alpha-OH DHP |
| 3alpha,5alpha-tetrahydroprogesterone |
| 3alpha,5alpha-THP |
| 4-08-00-00664 (Beilstein Handbook Reference) |
| 5-alpha-Pregnan-20-one, 3-alpha-hydroxy- |
| 516-54-1 |
| 516A541 |
| 5a-Pregnan-3a-ol-20-one |
| 5a-Pregnane-3a-ol-20-one |
| 5alpha pregnan 3alpha ol 20 one |
| 5alpha-Pregnan-3alpha-ol-20-one |
| 5alpha-Pregnan-3alpha-ol-20-one, solid |
| 5alpha-pregnane-3alpha-ol-20-one |
| 8E5D696A-EEBC-495D-A8C9-98FC9A593150 |
| AC-30353 |
| AC1L3OU1 |
| AKOS024285177 |
| Allopregnalone |
| Allopregnan-3|A-ol-20-one |
| Allopregnan-3a-ol-20-one |
| Allopregnan-3alpha-ol-20-one |
| Allopregnanolone |
| Allotetrahydroprogesterone |
| AN-45490 |
| AURFZBICLPNKBZ-SYBPFIFISA-N |
| B7456 |
| BDBM50191342 |
| BIDD:PXR0069 |
| Biomol-NT_000266 |
| BPBio1_000728 |
| BRD-K18172896-001-01-7 |
| brexanolona |
| Brexanolone |
| Brexanolone (USAN/INN) |
| Brexanolone [USAN] |
| brexanolonum |
| BRN 3211363 |
| C13712 |
| CAS-128-20-1 |
| CHEBI:50169 |
| CHEMBL207538 |
| CS-6401 |
| D11149 |
| DB11859 |
| DSSTox_CID_26342 |
| DSSTox_GSID_46342 |
| DSSTox_RID_81546 |
| DTXSID1046342 |
| EX-A1195 |
| GTPL4108 |
| HY-101107 |
| LMST02030156 |
| LS-118573 |
| MFCD00003677 |
| NCGC00163287-01 |
| NCGC00163287-02 |
| Pregnan-20-one, 3-hydroxy-, (3-alpha,5-alpha)- |
| Pregnan-20-one, 3-hydroxy-, (3-alpha,5-alpha)- (9CI) |
| Pregnan-20-one, 3-hydroxy-, (3a,5a)- |
| Pregnane-3alpha-ol-20-one, 5alpha- |
| Pregnanolone, (3alpha,5alpha)-isomer |
| S39XZ5QV8Y |
| SAGE-547 |
| SAGE547 |
| SCHEMBL588060 |
| SGE-102 |
| ST082264 |
| Tox21_112042 |
| UNII-S39XZ5QV8Y |
| ZINC4081043 |
US Patents and Regulatory Information for ZULRESSO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 ZULRESSO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 10201606063R | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009134347 | Start Trial |
| Japan | 2012072160 | Start Trial |
| South Korea | 101314803 | Start Trial |
| Japan | 2018052991 | Start Trial |
| Australia | 2018204865 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
