BENZONATATE Drug Patent Profile
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Which patents cover Benzonatate, and when can generic versions of Benzonatate launch?
Benzonatate is a drug marketed by Acella, Alembic Labs, Ascent Pharms Inc, Bionpharma Inc, Chartwell Rx, Cspc-nbp Pharm, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa. and is included in thirteen NDAs.
The generic ingredient in BENZONATATE is benzonatate. There are six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Benzonatate
A generic version of BENZONATATE was approved as benzonatate by BIONPHARMA INC on January 29th, 1993.
Summary for BENZONATATE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 42 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 4 |
| Patent Applications: | 2,877 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
See drug prices for BENZONATATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Thepharmanetwork Llc | BENZONATATE | benzonatate | CAPSULE;ORAL | 040627-002 | Jul 25, 2007 | AA | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms Usa | BENZONATATE | benzonatate | CAPSULE;ORAL | 040597-001 | Jun 8, 2007 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Acella | BENZONATATE | benzonatate | CAPSULE;ORAL | 091310-001 | Jan 16, 2015 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Nesher Pharms | BENZONATATE | benzonatate | CAPSULE;ORAL | 040795-001 | Oct 31, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Inds Inc | BENZONATATE | benzonatate | CAPSULE;ORAL | 040587-001 | Mar 19, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ascent Pharms Inc | BENZONATATE | benzonatate | CAPSULE;ORAL | 211518-003 | Feb 22, 2019 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
