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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Moodys
McKinsey
Dow
McKesson

Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Cevimeline hydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Cevimeline hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Novel Labs Inc, Rising, West-ward Pharms Int, and Daiichi Sankyo Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for cevimeline hydrochloride. Six suppliers are listed for this compound.

Recent Clinical Trials for cevimeline hydrochloride

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

SponsorPhase
Roxane LaboratoriesPhase 0
University of KentuckyN/A
Duke UniversityPhase 4

See all cevimeline hydrochloride clinical trials

Recent Litigation for cevimeline hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Daiichi Sankyo Co. Ltd. v. Sandoz Inc.2009-11-25
Daiichi Sankyo Co. Ltd. v. Apotex Inc.2009-06-26

See all cevimeline hydrochloride litigation

Pharmacology for cevimeline hydrochloride
Synonyms for cevimeline hydrochloride
(-)-Cevimeline hydrochloride hemihydrate
(+-)-cis-2-Methylspiro(1,3-oxathiolan-5,3')quinuclidine hydrochloride
(+/-)-cis-2-Methylspiro[1,3-oxathiolane-5,3'-quinuclidine]
(+/-)cis-2-methylspiro(1-azabicyclo[2.2.2]octance-3,5'-(1,3)oxathiolane) hydrochloride hemihydrate
(2R,2'R)-2'-methylspiro[4-azabicyclo[2.2.2]octane-2,5'-[1,3]oxathiolane] dihydrochloride hydrate
(2R,3'R)-2-methyl-1'-azaspiro[[1,3]oxathiolane-5,3'-bicyclo[2.2.2]octane] hydrochloride
(2R,5R)-2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane]
(2R,5R)-2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane] hydrate dihydrochloride
(2R,5R)-2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane] hydrate hydrochloride
(2R,5R)-2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane] hydrochloride
(3R,2'R)-2'-Methylspiro[1-azabicyclo[2.2.2]octane-3,5'-[1,3]oxathiolane]
107220-28-0
107233-08-9
124620-89-9
153504-70-2
2-Methyspiro(1,3-oxathiolane-5,3)quinuclidine
233C089
3537AH
ABP001056
AC1L36EF
AC1L36GD
AC1L3WYG
AC1OCEXD
AF 102B
AF-102B
AF102B
AKOS025294043
AKOS025311302
AKOS030526237
AKOS030526581
AKOS032944989
AN-33787
BIDD:GT0265
C10H17NOS
C10H17NOS.ClH
Cevimeline
Cevimeline (hydrochloride)
Cevimeline (INN)
Cevimeline [INN]
Cevimeline HCl
Cevimeline hydrochloride (USAN)
Cevimeline hydrochloride [USAN]
Cevimeline hydrochloride hemihydrate
Cevimeline hydrochloride hemihydrate, >=95% (HPLC, NMR)
Cevimeline hydrochloride hemihydrates
cevimeline hydrochloride hydrate
Cevimeline hydrochloride hydrate (JAN)
cevimeline trans-sulfoxide
Cevimeline, hydrochloride salt
Cevimeline,hydrochloride salt
Cevimeline.HCl
cis-(+-)-2'-Methylspiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)oxathiolane) hydrochloride
cis-2-Methylspiro(1,3-oxathiolane-5,3')quinuclidine hydrochloride hydrate (2:2:1)
cis-2'-Methylspiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)oxathiolane) hydrochloride
CS-0397
CS-4000
CTK8E6849
D00661
D07667
DTXSID2023777
DTXSID9022788
Evoxac
Evoxac (TN)
Fks 508
FKS-508
FT-0771641
HSDB 7286
HY-70020
HY-70020B
KS-00000XL8
LS-145778
LS-145781
LS-145782
LS-172037
MolPort-006-167-486
MolPort-044-561-459
PubChem19118
RT-011982
Saligren
Saligren (TN)
SCHEMBL188381
SCHEMBL1995469
SCHEMBL838481
SND 5008
SND 5008, AF-102B, FKS-508
SND-5008
SNI-2011
SNK 508
SNK-508
Spiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)-oxathiolane), 2'-methyl-, (2'R,3R)-rel-
Spiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)-oxathiolane), 2'-methyl-, cis-
Spiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)oxathiolane), 2'-methyl-, hydrochloride, cis-
Spiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)oxathiolane), 2'-methyl-, hydrochloride, cis-(+-)-
Spiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)oxathiolane), 2'-methyl-, hydrochloride, hydrate (2:1), cis-
UNII-H0913EZ23C component SURWTGAXEIEOGY-GHXDPTCOSA-N
UNII-K9V0CDQ56E component WUTYZMFRCNBCHQ-PSASIEDQSA-N
UNII-P81Q6V85NP component ZSTLCHCDLIUXJE-GMLJRNIPSA-N
W-5959
X7254
ZINC10163
Paragraph IV (Patent) Challenges for CEVIMELINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
EVOXAC CAPSULE;ORAL cevimeline hydrochloride 020989 2009-02-27

US Patents and Regulatory Information for cevimeline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Apotex Inc CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091260-001 Aug 25, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091591-001 Jul 8, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Rising CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 203775-001 Jun 4, 2014 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 cevimeline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000   Start Trial   Start Trial
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000   Start Trial   Start Trial
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Medtronic
Baxter
Express Scripts
AstraZeneca

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.