THEOPHYLLINE Drug Patent Profile
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Which patents cover Theophylline, and what generic alternatives are available?
Theophylline is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, Chartwell Molecular, Tris Pharma Inc, Able, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Nostrum Labs Inc, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, B Braun, Baxter Hlthcare, and Hospira Inc. and is included in fifty-three NDAs.
The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Theophylline
A generic version of THEOPHYLLINE was approved as theophylline by RHODES PHARMS on September 1st, 1982.
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Questions you can ask:
- What is the 5 year forecast for THEOPHYLLINE?
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- What is Average Wholesale Price for THEOPHYLLINE?
Summary for THEOPHYLLINE
| US Patents: | 0 |
| Applicants: | 34 |
| NDAs: | 53 |
| Finished Product Suppliers / Packagers: | 25 |
| Raw Ingredient (Bulk) Api Vendors: | 170 |
| Clinical Trials: | 111 |
| Patent Applications: | 3,962 |
| Drug Prices: | Drug price information for THEOPHYLLINE |
| DailyMed Link: | THEOPHYLLINE at DailyMed |
See drug prices for THEOPHYLLINE
Recent Clinical Trials for THEOPHYLLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tanta University | N/A |
| LG Chem | Phase 1 |
| University of Oklahoma | Phase 1/Phase 2 |
Pharmacology for THEOPHYLLINE
| Drug Class | Methylxanthine |
Medical Subject Heading (MeSH) Categories for THEOPHYLLINE
Anatomical Therapeutic Chemical (ATC) Classes for THEOPHYLLINE
US Patents and Regulatory Information for THEOPHYLLINE
THEOPHYLLINE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting THEOPHYLLINE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Braun | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | theophylline | INJECTABLE;INJECTION | 019826-003 | Aug 14, 1992 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bionpharma | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 216300-001 | Apr 26, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Able | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 040543-001 | Apr 27, 2004 | DISCN | No | 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 |
