Details for New Drug Application (NDA): 204819
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NDA 204819 describes ADEMPAS, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ADEMPAS profile page.
The generic ingredient in ADEMPAS is riociguat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riociguat profile page.
The generic ingredient in ADEMPAS is riociguat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riociguat profile page.
Summary for 204819
| Tradename: | ADEMPAS |
| Applicant: | Bayer Hlthcare |
| Ingredient: | riociguat |
| Patents: | 3 |
Pharmacology for NDA: 204819
| Mechanism of Action | Guanylate Cyclase Stimulators |
Suppliers and Packaging for NDA: 204819
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADEMPAS | riociguat | TABLET;ORAL | 204819 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-250 | 50419-250-01 | 90 TABLET, FILM COATED in 1 BOTTLE (50419-250-01) |
| ADEMPAS | riociguat | TABLET;ORAL | 204819 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-250 | 50419-250-03 | 2 BLISTER PACK in 1 PACKAGE (50419-250-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Oct 8, 2013 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 18, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 18, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 18, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS | ||||||||
Expired US Patents for NDA 204819
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-001 | Oct 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-002 | Oct 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-003 | Oct 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-004 | Oct 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-005 | Oct 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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