Regulatory Exclusivity Expiring in 2023
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Drugs with Regulatory Exclusivity Expiring in 2023
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
---|---|---|---|---|---|---|---|---|---|---|---|
Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | |
Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | RX | Yes | Yes | ⤷ Sign Up | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | RX | Yes | No | ⤷ Sign Up | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | RX | Yes | No | ⤷ Sign Up | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | RX | Yes | No | ⤷ Sign Up | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |