Par Sterile Products Company Profile
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What is the competitive landscape for PAR STERILE PRODUCTS, and what generic alternatives to PAR STERILE PRODUCTS drugs are available?
PAR STERILE PRODUCTS has thirty-eight approved drugs.
There are twenty US patents protecting PAR STERILE PRODUCTS drugs. There is one tentative approval on PAR STERILE PRODUCTS drugs.
There are nine patent family members on PAR STERILE PRODUCTS drugs in seven countries and sixty-five supplementary protection certificates in fourteen countries.
Summary for Par Sterile Products
| International Patents: | 9 |
| US Patents: | 20 |
| Tradenames: | 33 |
| Ingredients: | 33 |
| NDAs: | 38 |
| Patent Litigation for Par Sterile Products: | See patent lawsuits for Par Sterile Products |
Drugs and US Patents for Par Sterile Products
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | CALCITONIN-SALMON | calcitonin salmon | INJECTABLE;INJECTION | 209358-001 | Nov 10, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Par Sterile Products | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 211286-001 | Jan 17, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Par Sterile Products | TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 209382-003 | Sep 24, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-003 | Apr 21, 2023 | RX | Yes | Yes | 11,207,280 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-002 | Apr 21, 2023 | RX | Yes | Yes | 11,207,280 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Par Sterile Products | ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 205473-001 | Jul 29, 2015 | AP | RX | No | No | ⤷ 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 |
Expired US Patents for Par Sterile Products
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-002 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Try a Trial |
| Par Sterile Products | DANTRIUM | dantrolene sodium | INJECTABLE;INJECTION | 018264-001 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Try a Trial |
| Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-001 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Try a Trial |
| Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-003 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for PAR STERILE PRODUCTS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 20 units/mL, 1 mL | ➤ Subscribe | 2018-03-23 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Injection | 1 mg/mL ampules | ➤ Subscribe | 2016-03-09 |
International Patents for Par Sterile Products Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2019183416 | ⤷ Try a Trial |
| South Korea | 20180034307 | ⤷ Try a Trial |
| Canada | 3093725 | ⤷ Try a Trial |
| Australia | 2016233682 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2016149028 | ⤷ Try a Trial |
| China | 107614017 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Par Sterile Products Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 0694547 | 03C0003 | France | ⤷ Try a Trial | PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920 |
| 1453521 | 93156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 2782584 | C202130068 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
| 2701720 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
| 1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
