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DULERA Drug Profile
When do Dulera patents expire, and what generic alternatives are available?
Dulera is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-seven patent family members in twenty-six countries.
The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.
Summary for DULERA
| International Patents: | 37 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DULERA |
| Drug Sales Revenues: | Drug sales revenues for DULERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DULERA |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for DULERA |
| DailyMed Link: | DULERA at DailyMed |
Generic Entry Opportunity Date for DULERA
Generic Entry Date for DULERA*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS NDA:
Dosage:
AEROSOL, METERED;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for DULERA
| Drug Class | Corticosteroid beta2-Adrenergic Agonist |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Adrenergic beta2-Agonists |
US Patents and Regulatory Information for DULERA
| 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 | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Merck Sharp Dohme | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Merck Sharp Dohme | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Merck Sharp Dohme | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Merck Sharp Dohme | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Merck Sharp Dohme | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 DULERA
International Patents for DULERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 212355 | ➤ Sign Up |
| Indonesia | 30171 | ➤ Sign Up |
| Germany | 60003160 | ➤ Sign Up |
| Brazil | 0008699 | ➤ Sign Up |
| Spain | 2200837 | ➤ Sign Up |
| Portugal | 1156790 | ➤ Sign Up |
| Czech Republic | 294089 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for DULERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0613371 | 2002C/022 | Belgium | ➤ Sign Up | PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825 |
| 0613371 | SPC/GB02/033 | United Kingdom | ➤ Sign Up | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
