SITAGLIPTIN PHOSPHATE - Generic Drug Details

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

Sitagliptin phosphate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sitagliptin phosphate has fifty-two patent family members in forty countries.

There are thirty-four drug master file entries for sitagliptin phosphate. Three suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Summary for SITAGLIPTIN PHOSPHATE

International Patents:	52
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	40
Patent Applications:	114
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for SITAGLIPTIN PHOSPHATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SITAGLIPTIN PHOSPHATE
DailyMed Link:	SITAGLIPTIN PHOSPHATE at DailyMed

See drug prices for SITAGLIPTIN PHOSPHATE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SITAGLIPTIN PHOSPHATE

Dosage:

TABLET;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.

Recent Clinical Trials for SITAGLIPTIN PHOSPHATE

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

Sponsor	Phase
The Affiliated Hospital of Qingdao University	Phase 1
First Affiliated Hospital Xi'an Jiaotong University	N/A
Blandine Laferrere	N/A

See all SITAGLIPTIN PHOSPHATE clinical trials

Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		50MG	TABLET;ORAL
		25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SITAGLIPTIN PHOSPHATE

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Medical Subject Heading (MeSH) Categories for SITAGLIPTIN PHOSPHATE

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Incretins

Paragraph IV (Patent) Challenges for SITAGLIPTIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUVIA	Tablets	sitagliptin phosphate	50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	021995	1	2012-11-06
JANUVIA	Tablets	sitagliptin phosphate	100 mg/20 mg	021995	1	2012-06-25
JANUVIA	Tablets	sitagliptin phosphate	100 mg/10 mg and 100 mg/40 mg	021995	1	2012-06-19
JANUVIA	Tablets	sitagliptin phosphate	25 mg, 50 mg and 100 mg	021995	6	2010-10-18

US Patents and Regulatory Information for SITAGLIPTIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes					Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No					Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No

Expired US Patents for SITAGLIPTIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006

International Patents for SITAGLIPTIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Costa Rica	8117	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV
Montenegro	00405	So fosforne kiseline i inhibitora dipeptidil peptidaze-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Hong Kong	1095144	PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
New Zealand	544026	Phosphoric acid salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine
Poland	1654263
Croatia	P20070534
Montenegro	P60208	SO FOSFORNE KISJELINE I INHIBITORA DIPEPTIDIL PEPTIDAZE-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)

Supplementary Protection Certificates for SITAGLIPTIN PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
1412357	0790041-8	Sweden		PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
0896538	07C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321