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NORTHERA Drug Profile
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Which patents cover Northera, and when can generic versions of Northera launch?
Northera is a drug marketed by Lundbeck Na Ltd and is included in one NDA.
The generic ingredient in NORTHERA is droxidopa. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the droxidopa profile page.
Summary for NORTHERA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 16 |
| Patent Applications: | 32 |
| Drug Prices: | Drug price information for NORTHERA |
| DailyMed Link: | NORTHERA at DailyMed |
Generic Entry Opportunity Date for NORTHERA
Generic Entry Date for NORTHERA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEUROGENIC SYMPTOMATIC ORTHOSTATIC HYPOTENSION IN PATIENTS WITH PRIMARY AUTONOMIC FAILURE, DOPAMINE-BETA-HYDROXYLASE DEFICIENCY, AND NONDIABETIC AUTONOMIC NEUROPATHY NDA:
Dosage:
CAPSULE;ORAL |
*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 NORTHERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lundbeck LLC | Phase 4 |
| William Ondo, MD | Phase 4 |
| Arizona State University | Phase 2 |
Pharmacology for NORTHERA
| Physiological Effect | Increased Blood Pressure |
Synonyms for NORTHERA
| (-)-(2S,3R)-2-amino-3-hydroxy-3-(3,4-dihydroxyphenyl)propanoic acid |
| (-)-(2S,3R)-2-Amino-3-hydroxy-3-(3,4-dihydroxyphenyl)propionic acid |
| (-)-threo-3-(3,4-Dihydroxyphenyl)-L-serine |
| (2RS,3RS)-2-AMINO-3-(3,4-DIHYDROXY-PHENYL)-3-HYDROXY-PROPIONIC ACID |
| (2RS,3RS)-2-Amino-3-(3,4-dihydroxy-phenyl)-3-hydroxy-propionic acid;DL-DOPS;DL-Droxidopa |
| (2RS,3RS)-2-AMINO-3-(3,4-DIhydroxyphenyl)-3-HYDROXY-propanoic acid |
| (2S,3R)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid |
| (2S,3R)-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropionic Acid |
| (2S,3R)-3,4-dihydroxy-phenylserine |
| (betaR)-beta,3-dihydroxy-L-tyrosine |
| 1-14-00-00685 (Beilstein Handbook Reference) |
| 23651-95-8 |
| 23651-95-8,1260173-94-1(HCl) |
| 3,4-Dihydroxyphenylserine |
| 3916-18-5 |
| 43160-12-9 |
| 492-46-6 |
| 916A185 |
| AB01566868_01 |
| AC1L3P81 |
| AC1Q5QIU |
| AKOS015889899 |
| ANW-57465 |
| API0002500 |
| AX8126964 |
| BC214748 |
| BCP06516 |
| BDBM50103611 |
| beta,3-Dihydroxy-DL-tyrosine threo- |
| BRN 2852792 |
| CCG-222060 |
| CHEBI:31524 |
| CHEMBL2103827 |
| CS-2468 |
| CTK8B7488 |
| D,L-(3,4-Dihydroxyphenyl)serine |
| D01277 |
| D4235 |
| DB06262 |
| DL-threo-|A-(3,4-Dihydroxyphenyl)serine |
| DL-threo-3-(3,4-Dihydroxyphenyl)serine |
| DL-threo-3,4-Dihydroxyphenylserine |
| DL-threo-beta-(3,4-Dihydroxyphenyl)serine |
| DL-threo-Dihydroxyphenylserine |
| DL-threo-DOPS |
| DL-threo-Droxidopa |
| DL-Tyrosine, beta,3-dihydroxy-, threo- |
| DL-Tyrosine, beta,3-dihydroxy-, threo- (9CI) |
| DOPS |
| Dops (TN) |
| droxidopa |
| Droxidopa (JP17/INN) |
| Droxidopa (L-DOPS,SM-5688) |
| Droxidopa (L-DOPS) |
| Droxidopa (L-threo-3-(3,4-Dihydroxyphenyl)serine) |
| Droxidopa [Latin] |
| Droxidopa [USAN:INN:JAN] |
| droxidopum |
| EINECS 223-480-5 |
| FT-0651749 |
| FT-0667809 |
| GTPL7391 |
| H-DL--(3,4-Dihydroxyphenyl)-DL-Ser-OH |
| HY-13458 |
| J7A92W69L7 |
| KB-206605 |
| KB-62702 |
| KS-00000ZU4 |
| L-dihydroxyphenylserine |
| L-DOPS |
| L-DOPS, >=98% (HPLC) |
| L-threo 3,4-Dihydroxyphenylserine |
| L-threo DOPS |
| L-threo-3-(3,4-Dihydroxyphenyl)serine |
| L-threo-dihydroxyphenylserine |
| L-threo-DOPS |
| L-Threodops |
| L-Tyrosine, beta,3-dihydroxy-, (beta-R)- (9CI) |
| L-Tyrosine, beta,3-dihydroxy-, threo- |
| LS-145005 |
| MFCD00004266 |
| MolPort-006-115-789 |
| Norethra |
| Northera (TN) |
| Q-201050 |
| QXWYKJLNLSIPIN-JGVFFNPUSA-N |
| s3041 |
| SCHEMBL134299 |
| Serine, 3-(3,4-dihydroxyphenyl)-, DL-threo- |
| Serine, 3-(3,4-dihydroxyphenyl)-, L-threo- |
| SM 5688 |
| SM-5688 |
| SR-01000883755 |
| SR-01000883755-1 |
| TC-146210 |
| threo-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropionic acid |
| threo-b,3-dihydroxy-l-tyrosine |
| threo-beta,3-Dihydroxy-DL-tyrosine |
| threo-Dopaserine |
| UNII-24A0V01WKS component QXWYKJLNLSIPIN-JGVFFNPUSA-N |
| UNII-J7A92W69L7 |
| ZINC1482049 |
US Patents and Regulatory Information for NORTHERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202-001 | Feb 18, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202-002 | Feb 18, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202-001 | Feb 18, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Lundbeck Na Ltd | NORTHERA | droxidopa | CAPSULE;ORAL | 203202-002 | Feb 18, 2014 | RX | Yes | No | 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 |
