Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Last Updated: November 21, 2019

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Oseltamivir phosphate - Generic Drug Details

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What are the generic drug sources for oseltamivir phosphate and what is the scope of freedom to operate?

Oseltamivir phosphate is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Amneal Pharms, Hetero Labs Ltd Iii, Lupin Atlantis, Macleods Pharms Ltd, Natco Pharma Ltd, Nesher Pharms, Strides Pharma, Roche, Alvogen Pine Brook, Amneal Pharms Ny, and Teva Pharms Usa, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for oseltamivir phosphate. Twenty-four suppliers are listed for this compound.

Recent Clinical Trials for oseltamivir phosphate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Qingdao Municipal HospitalN/A
Jiangxi Qingfeng Pharmaceutical Co. Ltd.N/A
Beijing Luhe HospitalN/A

See all oseltamivir phosphate clinical trials

Recent Litigation for oseltamivir phosphate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Natco Pharma Limited2013-05-23
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED2011-08-29
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED2011-03-15

See all oseltamivir phosphate litigation

Medical Subject Heading (MeSH) Categories for oseltamivir phosphate
Synonyms for oseltamivir phosphate
(3R-(3alpha,4beta,5alpha)-Ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1)
(3R-(3alpha,4beta,5alpha))-Ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1)
(3R,4R,5S)-4-acetylamino-5-amino-3-(1-ethyl-propoxy)-cyclohex-1-enecarboxylic acid ethyl ester phosphate
(3R,4R,5S)-4-acetylamino-5-amino-3-(1-ethyl-propoxy)-cyclohex-1-enecarboxylic acid ethyl ester phosphoric acid salt
(3R,4R,5S)-ethyl 4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate phosphate
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, ethyl ester, (3R-(3alpha,4beta,5alpha)-, phosphate (1:1)
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, ethyl ester, (3R,4R,5S)-, phosphate
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, ethyl ester, (3R,4R,5S)-, phosphate (1:1)
204255-11-8
255O118
4A3O49NGEZ
AB0011433
ABP000749
AC-25911
AC1L2U9Q
ACT03369
AK143302
AKOS015896056
BC216470
BCP9001033
BCPP000138
C08093
C16H28N2O4.H3O4P
C16H28N2O4.H3PO4
CCG-230250
CHEBI:7799
CHEMBL1200340
CS-0871
D00900
DTXSID0044230
Ebilfumin (TN)
Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1)
Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate, phosphate (1:1)
ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate phosphate
Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-pentan-3-yloxycyclohexene-1-carboxylate phosphate
ethyl (3R,4R,5S)-4-acetamido-5-amino-3-pentan-3-yloxycyclohexene-1-carboxylate; phosphoric acid
ethyl (3R,4R,5S)-4-acetamido-5-amino-3-pentan-3-yloxycyclohexene-1-carboxylate;phosphoric acid
ethyl (3R,4R,5S)-5-amino-4-acetamido-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate; phosphoric acid
GS-4104
GS-4104/002
GS4104
HY-17016
I06-1861
J-013302
J-523838
J10429
KS-1184
LS-173828
MCULE-3939535663
MLS006011559
MolPort-005-938-626
Oseltamir Phosphate
Oseltamivir (phosphate)
Oseltamivir phosphate (impurity B free), European Pharmacopoeia (EP) Reference Standard
Oseltamivir phosphate (JAN/USAN)
Oseltamivir phosphate [USAN:USP]
Oseltamivir Phosphate [USAN]
Oseltamivir phosphate, >=98% (HPLC)
Oseltamivir phosphate, 98%
Oseltamivir Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material
Oseltamivir phosphate, United States Pharmacopeia (USP) Reference Standard
Osteltamivir phosphate
PGZUMBJQJWIWGJ-ONAKXNSWSA-N
phosphoric acid ethyl (3R,4R,5S)-5-amino-4-acetamido-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate
RL02533
Ro 64-0796
Ro 64-0796/002
Ro-64-0796
Ro-64-0796-002
Ro-64-0796/002
Ro-640796002
s2597
SCHEMBL8730
SMR004703323
SR-05000001499
SR-05000001499-2
SR-05000001960
SR-05000001960-1
ST24048849
Tamiflu
Tamiflu (TN)
UNII-4A3O49NGEZ
W-5362
Z1550675456
Paragraph IV (Patent) Challenges for OSELTAMIVIR PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
TAMIFLU CAPSULE;ORAL oseltamivir phosphate 021087 2011-08-02
TAMIFLU CAPSULE;ORAL oseltamivir phosphate 021087 2010-11-15
TAMIFLU FOR SUSPENSION;ORAL oseltamivir phosphate 021246

US Patents and Regulatory Information for oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nesher Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 208578-002 Feb 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Atlantis OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 208347-001 Feb 20, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209438-001 Feb 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 211823-001 Jun 24, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Nesher Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 209113-001 Sep 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209438-002 Feb 23, 2018 AB RX No 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

Expired US Patents for oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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