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: | 6,798 |
| 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 |
| National Institutes of Health (NIH) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Ltd | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 090372-001 | Nov 18, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 213163-001 | Nov 27, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 212475-002 | Sep 10, 2020 | 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 | |||
| Annora Pharma | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 212475-001 | Sep 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising Pharms | ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 204928-002 | Aug 25, 2022 | 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 | 020547-003 | Sep 17, 1999 | ⤷ 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 | 020547-001 | 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 |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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