DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021368
NDA 021368 describes CIALIS, which is a drug marketed by Lilly and is included in one NDA. It is available from nine suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIALIS profile page.
The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 021368
| Tradename: | CIALIS |
| Applicant: | Lilly |
| Ingredient: | tadalafil |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021368
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 021368
Suppliers and Packaging for NDA: 021368
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4462 | 0002-4462-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30) |
| CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4462 | 0002-4462-34 | 2 BLISTER PACK in 1 CARTON (0002-4462-34) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4462-79) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 21, 2003 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Feb 15, 2021 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 15, 2021 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | May 21, 2018 | Product Flag? | Substance Flag? | Delist Request? | |||
Expired US Patents for NDA 021368
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Complete Access Available with Subscription
