Details for New Drug Application (NDA): 021688
✉ Email this page to a colleague
NDA 021688 describes SENSIPAR, which is a drug marketed by Amgen and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SENSIPAR profile page.
The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 021688
| Tradename: | SENSIPAR |
| Applicant: | Amgen |
| Ingredient: | cinacalcet hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 021688
| Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Medical Subject Heading (MeSH) Categories for 021688
Suppliers and Packaging for NDA: 021688
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688 | NDA | A-S Medication Solutions | 50090-3529 | 50090-3529-0 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-3529-0) |
| SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688 | NDA | A-S Medication Solutions | 50090-7096 | 50090-7096-0 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-7096-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Mar 8, 2004 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,829,595 | Patent Expiration: | Sep 22, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA | ||||||||
| Patent: | 9,375,405 | Patent Expiration: | Sep 22, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Mar 8, 2004 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,829,595 | Patent Expiration: | Sep 22, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA | ||||||||
Expired US Patents for NDA 021688
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | 6,031,003 | ⤷ Subscribe |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,011,068 | ⤷ Subscribe |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | 6,011,068 | ⤷ Subscribe |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | 6,011,068 | ⤷ Subscribe |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,211,244 | ⤷ Subscribe |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,031,003 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
