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TIAZAC Drug Profile
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When do Tiazac patents expire, and what generic alternatives are available?
Tiazac is a drug marketed by Bausch and is included in one NDA.
The generic ingredient in TIAZAC is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Tiazac
A generic version of TIAZAC was approved as diltiazem hydrochloride by MYLAN on November 5th, 1992.
Summary for TIAZAC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,421 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TIAZAC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIAZAC |
| DailyMed Link: | TIAZAC at DailyMed |
Recent Clinical Trials for TIAZAC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 3 |
Pharmacology for TIAZAC
| Drug Class | Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Paragraph IV (Patent) Challenges for TIAZAC
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TIAZAC | CAPSULE, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 020401 |
US Patents and Regulatory Information for TIAZAC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-001 | Sep 11, 1995 | AB4 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-004 | Sep 11, 1995 | AB4 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-002 | Sep 11, 1995 | AB4 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-003 | Sep 11, 1995 | AB4 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-006 | Oct 16, 1998 | AB4 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 TIAZAC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-006 | Oct 16, 1998 | Start Trial | Start Trial |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-003 | Sep 11, 1995 | Start Trial | Start Trial |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-001 | Sep 11, 1995 | Start Trial | Start Trial |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-002 | Sep 11, 1995 | Start Trial | Start Trial |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-003 | Sep 11, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TIAZAC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69229949 | Start Trial |
| European Patent Office | 0591424 | Start Trial |
| Denmark | 0591424 | Start Trial |
| European Patent Office | 0953350 | Start Trial |
| Japan | 2000026278 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
