DrugPatentWatch Database Preview
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. One supplier is 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: | 1 |
Clinical Trials: | 4 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DULERA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 | Document Number | Estimated Expiration |
---|---|---|
New Zealand | 513742 | ➤ Sign Up |
Japan | 5646828 | ➤ Sign Up |
Chile | 2004001170 | ➤ Sign Up |
South Africa | 200106442 | ➤ Sign Up |
Israel | 144351 | ➤ Sign Up |
Russian Federation | 2270670 | ➤ Sign Up |
Canada | 2362499 | ➤ Sign Up |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for DULERA
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
02C/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 |
C/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 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |