BENZONATATE - Generic Drug Details
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What are the generic sources for benzonatate and what is the scope of freedom to operate?
Benzonatate
is the generic ingredient in two branded drugs marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, Zydus Pharms Usa, and Pfizer, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for benzonatate. Forty-four suppliers are listed for this compound.
Summary for BENZONATATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 14 |
| NDAs: | 14 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 44 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Clinical Trials: | 4 |
| Patent Applications: | 3,270 |
| Drug Prices: | Drug price trends for BENZONATATE |
| Drug Sales Revenues: | Drug sales revenues for BENZONATATE |
| What excipients (inactive ingredients) are in BENZONATATE? | BENZONATATE excipients list |
| DailyMed Link: | BENZONATATE at DailyMed |
Recent Clinical Trials for BENZONATATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 1 |
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 3 |
| Pfizer | Phase 1 |
Pharmacology for BENZONATATE
| Drug Class | Non-narcotic Antitussive |
| Physiological Effect | Decreased Tracheobronchial Stretch Receptor Activity |
Anatomical Therapeutic Chemical (ATC) Classes for BENZONATATE
US Patents and Regulatory Information for BENZONATATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | BENZONATATE | benzonatate | CAPSULE;ORAL | 040587-001 | Mar 19, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Heritage Pharms Labs | BENZONATATE | benzonatate | CAPSULE;ORAL | 040682-001 | Jul 30, 2007 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharms Labs | BENZONATATE | benzonatate | CAPSULE;ORAL | 040682-002 | Jul 30, 2007 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bionpharma | BENZONATATE | benzonatate | CAPSULE;ORAL | 081297-002 | Oct 30, 2007 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mikart | BENZONATATE | benzonatate | CAPSULE;ORAL | 040851-003 | Nov 9, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acella | BENZONATATE | benzonatate | CAPSULE;ORAL | 091310-001 | Jan 16, 2015 | AA | 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 |
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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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