ZAFIRLUKAST Drug Patent Profile
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When do Zafirlukast patents expire, and what generic alternatives are available?
Zafirlukast is a drug marketed by Annora Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, and Rising Pharms. and is included in four NDAs.
The generic ingredient in ZAFIRLUKAST is zafirlukast. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zafirlukast
A generic version of ZAFIRLUKAST was approved as zafirlukast by DR REDDYS LABS LTD on November 18th, 2010.
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Questions you can ask:
- What is the 5 year forecast for ZAFIRLUKAST?
- What are the global sales for ZAFIRLUKAST?
- What is Average Wholesale Price for ZAFIRLUKAST?
Summary for ZAFIRLUKAST
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 7 |
| Patent Applications: | 5,129 |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 204928-001 | 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 | |||
| 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 |
