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DIACOMIT Drug Profile

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When do Diacomit patents expire, and when can generic versions of Diacomit launch?

Diacomit is a drug marketed by Biocodex Sa and is included in two NDAs.

The generic ingredient in DIACOMIT is stiripentol. One supplier is listed for this compound. Additional details are available on the stiripentol profile page.

Summary for DIACOMIT

US Patents:	0
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	33
Patent Applications:	375
Formulation / Manufacturing:	see details
DailyMed Link:	DIACOMIT at DailyMed

Generic Entry Opportunity Date for DIACOMIT

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM

NDA:

206709

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM

NDA:

207223

Dosage:

FOR SUSPENSION;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.

Synonyms for DIACOMIT

(1E)-1-(2H-1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

(E)-1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-pent-1-en-3-ol

(E)-1-(1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

(E)-1-(3,4-Methylenedioxyphenyl)-4,4-dimethyl-1-penten-3-ol

(E)-1-(Benzo[d][1,3]dioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

1-(1,3-benzodioxol-5-yl)-4,4- dimethyl-1-penten-3-ol

1-(1,3-Benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol

1-(1,3-Benzodioxol-5yl)-4,4-dimethyl-1-penten-3-ol

1-(Benzo[d][1,3]dioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

1-Penten-3-ol, 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-

1-Penten-3-ol, 4,4-dimethyl-1-(3,4-methylenedioxyphenyl)-

137767-55-6

4,4-Dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-ol

4,4-Dimethyl-1-(3,4-methylenedioxyphenyl)-1-penten-3-ol

4,4-Dimethyl-1-[(3,4-methylenedioxy)phenyl]-1-penten-3-ol

4,4-dimethyl-1-[3,4(methylenedioxy)-phenyl]-1-penten-3-ol

49763-96-4

5-19-02-00640 (Beilstein Handbook Reference)

763S964

8269AH

AC1NSKO6

AKOS025149123

AKOS027255159

AN-41512

BCP10434

BCX 2600

BCX-2600

BCX2600

BRN 1313047

C14H18O3

CAS-49763-96-4

CCG-101092

CHEBI:94435

CHEMBL1983350

CPD000449279

CS-7801

D-306

D02XSA

D05928

DB09118

DSSTox_CID_28994

DSSTox_GSID_49068

DSSTox_RID_83259

DTXSID6049068

EBD2763

EINECS 256-480-9

Estiripentol

Estiripentol [INN-Spanish]

GTPL5469

HMS2052K07

HMS2232P06

HY-103392

IBLNKMRFIPWSOY-FNORWQNLSA-N

LS-102117

ME-2080

MFCD00869310

MLS000758313

MLS001424144

MolPort-005-942-442

NC00342

NCGC00185769-01

SAM001247042

SC-53649

SCHEMBL216436

SCHEMBL2533815

SMR000449279

STIRIPENTOL

Stiripentol (JAN/USAN/INN)

Stiripentol (oral)

Stiripentol (oral), Laboratoires Biocodex

Stiripentol [USAN:INN]

Stiripentol, >=98% (HPLC)

Stiripentolum

Stiripentolum [INN-Latin]

Tox21_113622

US Patents and Regulatory Information for DIACOMIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-001	Aug 20, 2018		RX	Yes	No
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-001	Aug 20, 2018		RX	Yes	No
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-001	Aug 20, 2018		RX	Yes	No