APRESOLINE Drug Patent Profile
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When do Apresoline patents expire, and what generic alternatives are available?
Apresoline is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in APRESOLINE is hydralazine hydrochloride; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.
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Questions you can ask:
- What is the 5 year forecast for APRESOLINE?
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Summary for APRESOLINE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 203 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,817 |
| DailyMed Link: | APRESOLINE at DailyMed |
Recent Clinical Trials for APRESOLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | N/A |
| University of Cincinnati | Phase 2 |
| Vanderbilt University Medical Center | Phase 2 |
US Patents and Regulatory Information for APRESOLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | APRESOLINE | hydralazine hydrochloride | INJECTABLE;INJECTION | 008303-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | APRESOLINE | hydralazine hydrochloride | TABLET;ORAL | 008303-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | APRESOLINE | hydralazine hydrochloride | TABLET;ORAL | 008303-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | APRESOLINE | hydralazine hydrochloride | TABLET;ORAL | 008303-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | APRESOLINE-ESIDRIX | hydralazine hydrochloride; hydrochlorothiazide | TABLET;ORAL | 012026-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | APRESOLINE | hydralazine hydrochloride | TABLET;ORAL | 008303-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
