Zafirlukast - Generic Drug Details
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What are the generic sources for zafirlukast and what is the scope of patent protection?
Zafirlukast
is the generic ingredient in two branded drugs marketed by Strides Pharma, Annora Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, and Rising Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for zafirlukast. Seven suppliers are listed for this compound.
Summary for zafirlukast
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 7 |
Patent Applications: | 6,781 |
Drug Prices: | Drug price trends for zafirlukast |
What excipients (inactive ingredients) are in zafirlukast? | zafirlukast excipients list |
DailyMed Link: | zafirlukast at DailyMed |
Recent Clinical Trials for zafirlukast
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allergy & Asthma Medical Group & Research Center | Phase 2 |
King Abdullah International Medical Research Center | Phase 3 |
Dana-Farber Cancer Institute | Phase 2 |
Pharmacology for zafirlukast
Drug Class | Leukotriene Receptor Antagonist |
Mechanism of Action | Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for zafirlukast
Paragraph IV (Patent) Challenges for ZAFIRLUKAST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACCOLATE | Tablets | zafirlukast | 10 mg and 20 mg | 020547 | 1 | 2008-02-29 |
US Patents and Regulatory Information for zafirlukast
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rising Pharms | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 204928-002 | Aug 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising Pharms | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 204928-001 | Aug 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 213163-002 | Nov 27, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 zafirlukast
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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