SIMVASTATIN; SITAGLIPTIN PHOSPHATE - Generic Drug Details
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What are the generic sources for simvastatin; sitagliptin phosphate and what is the scope of patent protection?
Simvastatin; 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 three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Simvastatin; sitagliptin phosphate has fifty-two patent family members in forty countries.
Summary for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
| International Patents: | 52 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SIMVASTATIN; SITAGLIPTIN PHOSPHATE |
| DailyMed Link: | SIMVASTATIN; SITAGLIPTIN PHOSPHATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
*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.
Anatomical Therapeutic Chemical (ATC) Classes for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Paragraph IV (Patent) Challenges for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JUVISYNC | Tablets | simvastatin; sitagliptin phosphate | 50 mg/10 mg 50 mg/20 mg 50 mg/40 mg | 202343 | 1 | 2012-11-06 |
| JUVISYNC | Tablets | simvastatin; sitagliptin phosphate | 100 mg/20 mg | 202343 | 1 | 2012-06-25 |
| JUVISYNC | Tablets | simvastatin; sitagliptin phosphate | 100 mg/10 mg and 100 mg/40 mg | 202343 | 1 | 2012-06-19 |
US Patents and Regulatory Information for SIMVASTATIN; 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 | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-002 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-003 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-001 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-005 | Sep 18, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-004 | Sep 18, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-006 | Sep 18, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 SIMVASTATIN; SITAGLIPTIN PHOSPHATE
International Patents for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 100430397 | ⤷ Sign Up | |
| Montenegro | P60208 | SO FOSFORNE KISJELINE I INHIBITORA DIPEPTIDIL PEPTIDAZE-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR) | ⤷ Sign Up |
| Japan | 2006516268 | ⤷ Sign Up | |
| Mexico | PA05013931 | SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV. (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR.) | ⤷ Sign Up |
| Spain | 2291907 | ⤷ Sign Up | |
| Ukraine | 86026 | СОЛЬ ФОСФОРНОЙ КИСЛОТЫ ИНГИБИТОРА ДИПЕПТИДИЛПЕПТИДАЗЫ-IV;СІЛЬ ФОСФОРНОЇ КИСЛОТИ ІНГІБІТОРА ДИПЕПТИДИЛПЕПТИДАЗИ-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR) | ⤷ Sign Up |
| Australia | 2004253889 | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | 26/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402 |
| 0720599 | 122004000026 | Germany | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402 |
| 0720599 | SPC/GB05/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
