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NORTHERA Drug Profile

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

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:	63
Clinical Trials:	16
Patent Applications:	27
Drug Prices:	Drug price information for NORTHERA
DailyMed Link:	NORTHERA at DailyMed

Generic Entry Opportunity 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:

203202

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.

Pharmacology for NORTHERA

Physiological Effect

Increased Blood Pressure

Medical Subject Heading (MeSH) Categories for NORTHERA

Antiparkinson Agents

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

AK-86903

AKOS015889899

AM009164

ANW-57465

API0002500

AX8126964

BC214748

BDBM50103611

beta,3-Dihydroxy-DL-tyrosine threo-

BRN 2852792

CCG-222060

CHEBI:31524

CHEMBL2103827

CS-2468

CTK8B7488

D,L-(3,4-Dihydroxyphenyl)serine

D01277

D0I3RO

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

H-DL-b-(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-3,4-dihydroxyphenylserine

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

SBB063961

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
Lundbeck Na Ltd	NORTHERA	droxidopa	CAPSULE;ORAL	203202-002	Feb 18, 2014		RX	Yes	No
Lundbeck Na Ltd	NORTHERA	droxidopa	CAPSULE;ORAL	203202-001	Feb 18, 2014		RX	Yes	No
Lundbeck Na Ltd	NORTHERA	droxidopa	CAPSULE;ORAL	203202-002	Feb 18, 2014		RX	Yes	No
Lundbeck Na Ltd	NORTHERA	droxidopa	CAPSULE;ORAL	203202-003	Feb 18, 2014		RX	Yes	Yes
Lundbeck Na Ltd	NORTHERA	droxidopa	CAPSULE;ORAL	203202-003	Feb 18, 2014		RX	Yes	Yes