Details for New Drug Application (NDA): 202020
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NDA 202020 describes RAYOS, which is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RAYOS profile page.
The generic ingredient in RAYOS is prednisone. There are sixteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.
The generic ingredient in RAYOS is prednisone. There are sixteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 202020
| Tradename: | RAYOS |
| Applicant: | Horizon |
| Ingredient: | prednisone |
| Patents: | 6 |
Pharmacology for NDA: 202020
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 202020
Suppliers and Packaging for NDA: 202020
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020 | NDA | Horizon Therapeutics USA, Inc. | 75987-020 | 75987-020-01 | 1 BOTTLE in 1 CARTON (75987-020-01) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE |
| RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020 | NDA | Horizon Therapeutics USA, Inc. | 75987-020 | 75987-020-02 | 1 BOTTLE in 1 CARTON (75987-020-02) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 26, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG PREDNISONE TABLET | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET | ||||||||
Expired US Patents for NDA 202020
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-002 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-001 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-002 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-003 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-001 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-003 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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