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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Harvard Business School
Fuji
QuintilesIMS
Cantor Fitzgerald
Healthtrust
Cipla
Chubb

Generated: July 17, 2018

DrugPatentWatch Database Preview

Fludarabine phosphate - Generic Drug Details

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What are the generic drug sources for fludarabine phosphate and what is the scope of fludarabine phosphate patent protection?

Fludarabine phosphate
is the generic ingredient in three branded drugs marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, and Sanofi Aventis Us, and is included in thirteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fludarabine phosphate has sixty-nine patent family members in thirty-four countries.

There are ten drug master file entries for fludarabine phosphate. Eight suppliers are listed for this compound.
Pharmacology for fludarabine phosphate
Synonyms for fludarabine phosphate
((2R,3S,4S,5R)-5-(6-amino-2-fluoro-9H-purin-9-yl)-3,4-dihydroxytetrahydrofuran-2-yl)methyl dihydrogen phosphate
[(2R,3S,4S,5R)-5-(6-amino-2-fluoropurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl dihydrogen phosphate
{[(2R,3S,4S,5R)-5-(6-AMINO-2-FLUORO-9H-PURIN-9-YL)-3,4-DIHYDROXYOXOLAN-2-YL]METHOXY}PHOSPHONIC ACID
1X9VK9O1SC
2-F-ara-AMP
2-Fluoro-9-(5-O-phosphono-beta-D-arabinofuranosyl)-9H-purin-6-amine
2-Fluoro-ARA AMP
2-Fluoro-ara-AMP
2-Fluoroadenine arabinoside 5'-monophosphate
2F-ara-AMP
607F679
75607-67-9
9 beta-D-arabinofuranosyl-2-fluoroadenine monophosphate
9-beta-Arabinofuranosyl-2-fluoroadenine-5'-phosphate
9-beta-D-Arabinofuranosyl-2-fluoroadenine 5'-(dihydrogen phosphate)
9-beta-D-Arabinofuranosyl-2-fluoroadenine 5'-monophosphate
9-BETA-D-ARABINOFURANOSYL-2-FLUOROADENINE-5'-DIHYD
9-beta-D-Arabinofuranosyl-2-fluoroadenine-5'-monophosphate
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-beta-D-arabinofuranosyl)-
AB0014146
AC1L1K7D
AK162583
AKOS024464516
Ambap13311-84-7
AOB4772
API0002720
AS-14202
AX8034836
BCP0726000268
BCP9000694
Beneflur
C-21000
C10H13FN5O7P
CC-28457
CCG-213521
CF0043
CHEBI:63599
CHEMBL1096882
CS-0861
D01907
DTXSID2023060
F-ara-AMP
FAMP
FaraAMP
Fluclarabine phosphate
fludara
Fludara (TN)
Fludarabine (phosphate)
Fludarabine 5'-monophosphate
Fludarabine monophosphate
Fludarabine Phosphate (Fludara)
Fludarabine phosphate (JAN/USP)
Fludarabine phosphate [USAN:BAN]
Fludarabine phosphate [USAN:USP:BAN]
Fludarabine phosphate;
Fludarabine Phosphate(Fludara)
Fludarabinephosphate
Fludura
fluoro-ara-AMP
FT-0630840
GIUYCYHIANZCFB-FJFJXFQQSA-N
HMS2094O11
HY-B0028
J10402
K294
KB-51878
LS-126393
MFCD00866418
MLS003915617
MLS004774150
MolPort-003-666-877
NSC 312887
NSC 328002
NSC-312887
NSC-312887|||[(2R,3S,4S,5R)-5-(6-amino-2-fluoropurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl dihydrogen phosphate
NSC-759194
NSC759194
NU001826
NU001827
Oforta
Pharmakon1600-01505705
PubChem21445
RL04879
s1229
SBI-0206893.P001
SC-13783
SCHEMBL3511
SHT-586
SMR002544683
SR-05000001945
SR-05000001945-4
SRI-5907_05
SRI-5907_07
SRI-5907-04
ST24047210
UNII-1X9VK9O1SC
W-5142
Z2235802254
ZINC3927870

US Patents and Regulatory Information for fludarabine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Llc FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 203738-001 Feb 28, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sagent Pharms FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 076661-001 Apr 28, 2004 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 077790-001 Apr 6, 2007 AP RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078393-001 Oct 15, 2007 AP RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for fludarabine phosphate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,046,322 Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5% ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Colorcon
Accenture
Daiichi Sankyo
McKesson
Johnson and Johnson
Argus Health
Baxter
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.