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Zydus Pharms Usa Company Profile
What is the competitive landscape for ZYDUS PHARMS USA, and when can generic versions of ZYDUS PHARMS USA drugs launch?
There is one US patent protecting ZYDUS PHARMS USA drugs. There are nine tentative approvals on ZYDUS PHARMS USA drugs.
There are two patent family members on ZYDUS PHARMS USA drugs in two countries and two hundred and thirty supplementary protection certificates in thirteen countries.
Summary for Zydus Pharms Usa
| International Patents: | 2 |
| US Patents: | 1 |
| Tradenames: | 134 |
| Ingredients: | 134 |
| NDAs: | 159 |
Drugs and US Patents for Zydus Pharms Usa
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms Usa Inc | TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 207382-003 | Nov 24, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Zydus Pharms Usa Inc | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205228-001 | Jul 17, 2017 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Zydus Pharms Usa | ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077625-001 | Oct 16, 2006 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Zydus Pharms Usa Inc | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 208961-003 | Dec 27, 2017 | AB | RX | No | No | ➤ 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 |
Paragraph IV (Patent) Challenges for ZYDUS PHARMS USA drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
Non-Orange Book US Patents for Zydus Pharms Usa
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,139,527 | Method of preparation of pitavastatin and pharmaceutical acceptable salts thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Zydus Pharms Usa Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2013516459 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2011089623 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Zydus Pharms Usa Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0040 | France | ➤ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
| 2000 00018 | Denmark | ➤ Sign Up | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
| C/GB95/028 | United Kingdom | ➤ Sign Up | PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718 |
| 2013025,C1304992 | Lithuania | ➤ Sign Up | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.
