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TEMBEXA Drug Patent Profile

When do Tembexa patents expire, and when can generic versions of Tembexa launch?

Tembexa is a drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this drug.

This drug has forty-seven patent family members in fifteen countries.

The generic ingredient in TEMBEXA is brincidofovir. Two suppliers are listed for this compound. Additional details are available on the brincidofovir profile page.

DrugPatentWatch^® Generic Entry Outlook for Tembexa

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 31, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TEMBEXA

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	207
What excipients (inactive ingredients) are in TEMBEXA?	TEMBEXA excipients list
DailyMed Link:	TEMBEXA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEMBEXA

Constraining patent/regulatory exclusivity:

9,303,051

NDA:

214460

Dosage:

SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

8,962,829

NDA:

214461

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for TEMBEXA

TEMBEXA is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,303,051.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes	9,303,051		Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	8,962,829		Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	10,112,909
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	9,371,344		Y
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes

International Patents for TEMBEXA

When does loss-of-exclusivity occur for TEMBEXA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TEMBEXA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3020720	DÉRIVÉS ESTERS PHOSPHONATES ET LEURS PROCÉDÉS DE SYNTHÈSE (PHOSPHONATE ESTER DERIVATIVES AND METHODS OF SYNTHESIS THEREOF)
Japan	2016094388	ホスホン酸エステル誘導体およびその合成方法 (PHOSPHONATE ESTER DERIVATIVE AND METHOD OF SYNTHESIS THEREOF)
Eurasian Patent Organization	201691006	МОРФОЛОГИЧЕСКИЕ ФОРМЫ ГЕКСАДЕЦИЛОКСИПРОПИЛОВЫХ СЛОЖНЫХ ЭФИРОВ ФОСФОНОВОЙ КИСЛОТЫ И СПОСОБЫ ИХ СИНТЕЗА
Russian Federation	2581045	ПРОИЗВОДНЫЕ ЭФИРОВ ФОСФОНОВЫХ КИСЛОТ И СПОСОБЫ ИХ СИНТЕЗА (PHOSPHONIC ACID ESTERS AND METHODS FOR SYNTHESIS THEREOF)
Mexico	2016006241	FORMAS MORFICAS DE ESTERES DE HEXADECILOXIPROPIL-FOSFONATO. (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS.)
Israel	302520	צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)

TEMBEXA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TEMBEXA

Introduction to TEMBEXA

TEMBEXA, also known as brincidofovir, is an oral antiviral drug approved by the U.S. Food and Drug Administration (FDA) in June 2021 for the treatment of human smallpox disease caused by the variola virus in adult and pediatric patients, including neonates[4].

Market Need and Demand

The demand for TEMBEXA is driven by the need for medical countermeasures against smallpox, a highly infectious and potentially deadly disease. Governments and health organizations worldwide are keen to maintain strategic stockpiles of effective treatments to prepare for potential pandemics. This need is underscored by the U.S. government's ongoing efforts to procure and stockpile TEMBEXA[1][4].

Chimerix and the Development of TEMBEXA

Chimerix, Inc., a biopharmaceutical company, developed TEMBEXA with the mission of improving and extending the lives of patients facing deadly diseases. The company's efforts in developing TEMBEXA were significant, with research and development expenses increasing to $15.3 million in the third quarter of 2022[2].

Sale to Emergent BioSolutions

In May 2022, Chimerix announced the sale of its exclusive worldwide rights to TEMBEXA to Emergent BioSolutions for up to $337.5 million, plus royalties. This transaction included a $225 million upfront payment and potential milestone payments of up to $100 million contingent on future procurement options by the U.S. government[3][5].

Financial Implications of the Sale

The sale of TEMBEXA to Emergent BioSolutions had a substantial financial impact on Chimerix. The company received a significant upfront payment, which helped secure substantial capital to fund its operations and focus on its development pipeline. The transaction also included sales-based royalties, ensuring Chimerix would benefit from future worldwide procurement of TEMBEXA[3][5].

Procurement Contracts and Revenue

Chimerix secured a $9.3 million international procurement agreement for TEMBEXA before the sale to Emergent. This contract highlighted the drug's utility as a medical countermeasure and the importance of maintaining strategic stockpiles[1].

After the sale, Emergent BioSolutions executed contract options valued at $67.4 million to procure additional treatment courses of TEMBEXA, supporting the U.S. government's national preparedness efforts. These contracts are part of a 10-year agreement with a maximum potential value of $568 million[4].

Financial Performance Post-Sale

Following the sale of TEMBEXA, Chimerix reported significant financial improvements. In the third quarter of 2022, the company's revenues increased, largely due to the procurement revenue from TEMBEXA. Chimerix recorded $31.971 million in procurement revenue and a net income of $241.362 million, a substantial turnaround from previous losses[2].

Royalty Structure

Under the terms of the agreement with Emergent, Chimerix is entitled to receive a 15% royalty on gross profit associated with international revenue and a 20% royalty on gross profit associated with U.S. revenue from sales in excess of 1.7 million treatment courses of therapy[1].

Market Positioning and Partnerships

The acquisition by Emergent BioSolutions positions TEMBEXA within a leading global biodefense company, leveraging Emergent's long history of partnering with the U.S. government to address public health threats. This partnership is expected to maximize the long-term potential of TEMBEXA and ensure pandemic preparedness[3][5].

Regulatory and Government Support

The U.S. government, through the Biomedical Advanced Research and Development Authority (BARDA), has been a key player in the procurement and stockpiling of TEMBEXA. BARDA issued a sole source request for proposal to procure up to 1.7 million treatment courses of TEMBEXA, further solidifying the drug's importance in national preparedness efforts[5].

Future Outlook

The future outlook for TEMBEXA is promising, with ongoing procurement contracts and the potential for additional milestone payments. The drug's inclusion in the U.S. Strategic National Stockpile and its approval for all ages, including neonates, ensure its continued relevance in public health preparedness[4].

Market Expansion

The acquisition by Emergent BioSolutions also opens up opportunities for market expansion. With Emergent's global reach and experience in medical countermeasures, TEMBEXA is poised to become a critical component in international smallpox preparedness strategies[5].

Key Takeaways

• Approval and Indication: TEMBEXA is FDA-approved for treating human smallpox disease in all ages.
• Sale to Emergent: Chimerix sold TEMBEXA to Emergent BioSolutions for up to $337.5 million plus royalties.
• Procurement Contracts: Significant procurement contracts with the U.S. government, including a $67.4 million contract executed by Emergent.
• Financial Impact: The sale significantly improved Chimerix's financial position, with substantial upfront and potential milestone payments.
• Market Positioning: TEMBEXA is now part of Emergent BioSolutions' portfolio, enhancing its market presence and long-term value.
• Regulatory Support: Strong support from BARDA and the U.S. government for procurement and stockpiling.

FAQs

Q: What is TEMBEXA, and what is it used for?

A: TEMBEXA, or brincidofovir, is an oral antiviral drug approved by the FDA for the treatment of human smallpox disease caused by the variola virus in adult and pediatric patients, including neonates.

Q: Who developed TEMBEXA?

A: TEMBEXA was developed by Chimerix, Inc., a biopharmaceutical company.

Q: Who acquired the rights to TEMBEXA?

A: Emergent BioSolutions acquired the exclusive worldwide rights to TEMBEXA from Chimerix in May 2022.

Q: What was the financial arrangement for the sale of TEMBEXA?

A: The sale included a $225 million upfront payment, potential milestone payments of up to $100 million, and sales-based royalties.

Q: How does the U.S. government support the procurement of TEMBEXA?

A: The U.S. government, through BARDA, has issued procurement contracts and maintains strategic stockpiles of TEMBEXA to ensure national preparedness against smallpox.

Cited Sources:

1. Chimerix Announces $9.3 Million International TEMBEXA Procurement Agreement - BioSpace
2. Chimerix Reports Third Quarter 2022 Financial Results and - Chimerix IR
3. Chimerix Announces Sale of TEMBEXA to Emergent BioSolutions - Chimerix IR
4. Emergent BioSolutions Announces the Execution of Contract Options Valued at $67.4 Million to Procure Additional TEMBEXA - BioSpace
5. Emergent BioSolutions to Acquire from Chimerix its Exclusive Worldwide Rights to TEMBEXA - BioSpace