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NASONEX Drug Profile
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Which patents cover Nasonex, and what generic alternatives are available?
Nasonex is a drug marketed by Merck Sharp Dohme and is included in one NDA.
The generic ingredient in NASONEX is mometasone furoate. There are thirty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
US ANDA Litigation and Generic Entry Outlook for Nasonex
A generic version of NASONEX was approved as mometasone furoate by PERRIGO NEW YORK on March 18th, 2002.
Summary for NASONEX
Recent Clinical Trials for NASONEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 4 |
| EMS | Phase 3 |
| Nasaleze | Phase 4 |
Pharmacology for NASONEX
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for NASONEX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NASONEX | SPRAY, METERED;NASAL | mometasone furoate | 020762 | 2009-08-07 |
US Patents and Regulatory Information for NASONEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NASONEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NASONEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 165803 | Start Trial |
| Taiwan | 329387 | Start Trial |
| Portugal | 2156840 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9520393 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NASONEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0057401 | 94C0004 | Belgium | Start Trial | PRODUCT NAME: MOMETASONI FUROAS; NAT REG.: 304 S 133 F 7 19930813; FIRST REG.: GR 10682/89 19900622 |
| 0548114 | 19875032 | Germany | Start Trial | PRODUCT NAME: MOMETASON-FUROAT-MONOHYDRAT; NAT. REGISTRATION NO/DATE: 40803.00.00 19980218; FIRST REGISTRATION: FRANKREICH NL 22055 19970219 |
| 0548114 | C980012 | Netherlands | Start Trial | PRODUCT NAME: MOMETASONI FUROAS MONOHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21613 19971209; FIRST REGISTRATION: FR NL22055 19970219 |
| 0548114 | 980012 | Netherlands | Start Trial | 980012, 20110905, EXPIRES: 20160905 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
